46 Clinical Research Associate jobs in Hyderabad
Senior Clinical Research Associate
500001 Hyderabad, Andhra Pradesh
₹90000 Annually
WhatJobs
Posted 16 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a highly skilled Senior Clinical Research Associate to join their team in Hyderabad, Telangana . This critical role will involve overseeing and managing clinical trials, ensuring compliance with regulatory standards, and contributing to the development of life-saving medications. The ideal candidate will possess extensive knowledge of clinical trial processes, strong analytical skills, and a meticulous approach to data management and site monitoring.
Key Responsibilities include:
Qualifications:
Key Responsibilities include:
- Conducting site feasibility visits, initiation visits, routine monitoring visits, and close-out visits for clinical trials.
- Ensuring that clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and applicable regulatory requirements (e.g., GCP, ICH guidelines).
- Managing study conduct at assigned clinical sites, ensuring subject safety and data integrity.
- Training and mentoring junior CRAs and site staff on trial-related procedures.
- Reviewing and verifying source documents, case report forms (CRFs), and study-related documentation.
- Identifying, assessing, and resolving site-specific issues and risks.
- Communicating effectively with investigators, site staff, project teams, and other stakeholders.
- Tracking study progress, timelines, and budget adherence at the site level.
- Preparing monitoring visit reports and ensuring timely follow-up on action items.
- Contributing to the development of clinical trial protocols and other study documents.
- Participating in investigator meetings and training sessions.
- Ensuring all regulatory requirements and documentation are met for assigned sites.
- Maintaining up-to-date knowledge of therapeutic areas and relevant scientific advancements.
Qualifications:
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related discipline. Advanced degree (MSc, PhD) is preferred.
- Minimum of 4-6 years of experience as a Clinical Research Associate or in a similar role within the pharmaceutical or biotechnology industry.
- In-depth knowledge of GCP, ICH guidelines, and other relevant regulatory requirements.
- Proven experience in monitoring clinical trials across various therapeutic areas.
- Excellent written and verbal communication skills, with strong report-writing abilities.
- Strong organizational, problem-solving, and analytical skills.
- Ability to travel extensively to clinical sites as required.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Demonstrated ability to manage multiple projects and meet deadlines.
- Experience in mentoring or leading junior team members.
- Strong interpersonal skills for effective collaboration with diverse teams.
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0
Clinical Research Associate (CRA)
500001 Hyderabad, Andhra Pradesh
₹80000 Annually
WhatJobs
Posted 18 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company renowned for its innovative drug development, is seeking a highly skilled and motivated Clinical Research Associate (CRA) to join their team based in Hyderabad, Telangana, IN . This critical role involves overseeing and managing clinical trials to ensure compliance with protocols, regulations, and Good Clinical Practice (GCP) guidelines. You will be responsible for monitoring study sites, ensuring the accuracy and completeness of data, and verifying the rights and well-being of study participants.
Key Responsibilities:
Qualifications:
This is an exceptional opportunity for a dedicated CRA to contribute to groundbreaking research and patient care within a world-class pharmaceutical organization located in Hyderabad, Telangana, IN .
Key Responsibilities:
- Conduct site initiation, monitoring, and close-out visits to ensure adherence to study protocols and regulatory requirements.
- Verify the accuracy, completeness, and integrity of clinical trial data through source data verification.
- Ensure compliance with GCP, FDA regulations, and other relevant health authority guidelines.
- Train and support site personnel on study-related procedures, data collection, and regulatory requirements.
- Manage communication between the study sponsor and the clinical sites.
- Identify, document, and resolve site-level issues and deviations.
- Prepare and present study progress reports to management.
- Ensure timely submission of essential study documents.
- Maintain effective working relationships with investigators, site staff, and other stakeholders.
- Participate in the development and review of study protocols and Case Report Forms (CRFs).
Qualifications:
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related scientific discipline.
- Minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical research role.
- Thorough understanding of ICH-GCP guidelines and regulatory requirements for clinical trials.
- Demonstrated experience in site monitoring and data verification.
- Excellent communication, interpersonal, and problem-solving skills.
- Strong organizational skills with meticulous attention to detail.
- Ability to travel to various study sites as required.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
This is an exceptional opportunity for a dedicated CRA to contribute to groundbreaking research and patient care within a world-class pharmaceutical organization located in Hyderabad, Telangana, IN .
This advertiser has chosen not to accept applicants from your region.
1
Senior Clinical Research Associate
500081 Hyderabad, Andhra Pradesh
₹70000 Monthly
WhatJobs
Posted 18 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is looking for an experienced Senior Clinical Research Associate (CRA) to join their team in Hyderabad, Telangana, IN . This role offers a hybrid work model, allowing for a balance between remote flexibility and in-office collaboration. The Senior CRA will play a pivotal role in ensuring the successful execution of clinical trials, adhering to strict regulatory guidelines and company standards.
As a Senior CRA, you will be responsible for monitoring clinical trial sites, ensuring data integrity, and safeguarding patient safety. Your expertise will be crucial in managing multiple studies simultaneously, building strong relationships with investigators and site staff, and driving the overall quality of research.
Key Responsibilities:
As a Senior CRA, you will be responsible for monitoring clinical trial sites, ensuring data integrity, and safeguarding patient safety. Your expertise will be crucial in managing multiple studies simultaneously, building strong relationships with investigators and site staff, and driving the overall quality of research.
Key Responsibilities:
- Conduct site visits (pre-study, initiation, interim monitoring, and close-out) to assess protocol compliance, data accuracy, and patient safety.
- Ensure that clinical trials are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and all applicable regulatory requirements.
- Verify the accuracy and completeness of source data and source documents through comparison with case report forms (CRFs).
- Train and mentor junior CRAs and site staff on trial procedures, GCP, and regulatory compliance.
- Manage and maintain effective communication with clinical trial investigators, site staff, and internal project teams.
- Identify, evaluate, and escalate potential risks and issues related to clinical trial conduct and data quality.
- Prepare and present monitoring visit reports, ensuring timely resolution of action items.
- Assist in the development of trial-related documents, such as protocols, informed consent forms, and monitoring plans.
- Ensure all investigational product is accounted for and managed appropriately at the trial sites.
- Contribute to the continuous improvement of clinical research processes and SOPs.
- Bachelor's or Master's degree in Life Sciences, Pharmacy, Nursing, or a related field.
- Minimum of 5 years of experience as a Clinical Research Associate, with demonstrated experience in monitoring complex clinical trials.
- Thorough understanding of ICH-GCP guidelines and relevant regulatory requirements (e.g., CDSCO).
- Proven ability to manage multiple clinical trial sites and studies simultaneously.
- Excellent interpersonal, communication, and presentation skills.
- Strong organizational skills and attention to detail.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to clinical trial sites as required (approximately 50-60% travel).
- Experience in (Specific Therapeutic Area, e.g., Oncology, Cardiology) is highly desirable.
This advertiser has chosen not to accept applicants from your region.
2
Senior Clinical Research Associate
500030 Hyderabad, Andhra Pradesh
₹1200000 Annually
WhatJobs
Posted 18 days ago
Job Viewed
Job Description
Our client, a leading innovator in pharmaceutical research and development, is seeking a highly experienced Senior Clinical Research Associate (CRA) to join their dynamic team in **Hyderabad, Telangana, IN**. This is a critical role responsible for ensuring the successful execution of clinical trials according to Good Clinical Practice (GCP), protocol, and regulatory requirements. The Senior CRA will oversee all site management activities, including site selection, initiation, monitoring, and close-out.
Responsibilities:
Responsibilities:
- Identify, evaluate, and select clinical trial sites, ensuring they meet all necessary ethical and regulatory standards.
- Initiate study sites, conduct pre-study visits, and ensure that all regulatory requirements and documentation are met before study commencement.
- Conduct routine monitoring visits (on-site and remote) to assess patient safety, data integrity, protocol compliance, and adherence to regulatory requirements.
- Manage a portfolio of clinical sites, building strong relationships with investigators and site staff.
- Prepare and present comprehensive monitoring visit reports, identifying deviations and proposing corrective actions.
- Oversee the management of investigational product and study supplies at study sites.
- Ensure timely resolution of site issues and implementation of action plans to improve site performance.
- Assist in the preparation of regulatory submissions and respond to inquiries from regulatory authorities.
- Mentor and provide guidance to junior CRAs, fostering a collaborative team environment.
- Contribute to the development and refinement of clinical trial protocols and standard operating procedures (SOPs).
- Bachelor's or Master's degree in Life Sciences, Pharmacy, Nursing, or a related scientific field.
- Minimum of 5 years of experience as a Clinical Research Associate, with a proven track record of managing complex clinical trials.
- In-depth knowledge of ICH-GCP guidelines, local regulatory requirements, and clinical trial processes.
- Strong understanding of medical terminology, clinical procedures, and data management.
- Excellent communication, interpersonal, and negotiation skills.
- Ability to travel up to 50% of the time to various study sites.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Demonstrated ability to work independently and as part of a cross-functional team.
This advertiser has chosen not to accept applicants from your region.
3
Senior Clinical Research Associate (CRA)
500030 Hyderabad, Andhra Pradesh
₹90000 Monthly
WhatJobs
Posted today
Job Viewed
Job Description
Our client, a leading pharmaceutical innovator, is seeking a dedicated and experienced Senior Clinical Research Associate (CRA) to join their esteemed team in Hyderabad, Telangana, IN . This pivotal role involves overseeing and managing clinical trials, ensuring compliance with regulatory standards, and contributing to the successful development of new therapeutic agents. The Senior CRA will be responsible for site selection, initiation, monitoring, and closure of clinical trial sites, as well as ensuring the accuracy and integrity of data collected. You will serve as the primary point of contact for investigative sites, providing training and support to site personnel, and resolving any issues that may arise during the trial.
Responsibilities:
Responsibilities:
- Conduct pre-study, initiation, interim, and close-out visits for clinical trial sites according to protocol and regulatory guidelines.
- Monitor study conduct, ensuring compliance with Good Clinical Practice (GCP), FDA regulations, and other applicable guidelines.
- Verify the accuracy, completeness, and validity of clinical data through source document review and source data verification (SDV).
- Manage site relationships, providing ongoing training, support, and motivation to investigators and study staff.
- Ensure timely submission of essential documents and maintenance of the Trial Master File (TMF).
- Identify, document, and escalate study-related issues, deviations, and adverse events.
- Prepare and present monitoring reports and site performance summaries to the study team.
- Collaborate with internal study teams, including project managers, data managers, and medical monitors.
- Contribute to the development of study protocols, case report forms (CRFs), and other study-related documents.
- Ensure adherence to project timelines and budgets.
- Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
- Minimum of 5 years of experience as a Clinical Research Associate in the pharmaceutical or biotech industry.
- In-depth knowledge of ICH-Good Clinical Practice (GCP) guidelines and applicable regulatory requirements (e.g., FDA, EMA).
- Proven experience in site management, monitoring, and data verification.
- Excellent understanding of clinical trial processes and documentation.
- Strong analytical and problem-solving skills.
- Exceptional organizational and time management abilities.
- Outstanding communication, interpersonal, and negotiation skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to investigative sites as required (approximately 50-60%).
This advertiser has chosen not to accept applicants from your region.
4
Senior Clinical Research Associate (CRA)
500001 Hyderabad, Andhra Pradesh
₹900000 Annually
WhatJobs
Posted today
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking an experienced Senior Clinical Research Associate (CRA) to join their dynamic team. This role plays a crucial part in the successful execution of clinical trials, ensuring compliance with protocols, regulatory requirements, and ethical standards. The Senior CRA will be responsible for monitoring study sites, managing data integrity, and ensuring patient safety throughout the trial lifecycle. This hybrid position offers a blend of remote work flexibility and essential on-site engagement with study sites and internal teams.
Responsibilities:
Responsibilities:
- Conduct site initiation, interim monitoring, and site closure visits in accordance with Good Clinical Practice (GCP) and regulatory guidelines.
- Verify the accuracy and completeness of clinical data, ensuring data integrity and protocol adherence.
- Train and support investigators and site staff on study procedures, protocol requirements, and regulatory compliance.
- Manage communication between study sites, the clinical operations team, and other relevant departments.
- Ensure timely resolution of site-related issues and discrepancies.
- Maintain accurate and up-to-date study documentation, including site files and monitoring reports.
- Participate in the selection and qualification of study sites and investigators.
- Contribute to the development of clinical trial protocols and other study documents.
- Monitor study progress, identify potential risks, and implement mitigation strategies.
- Stay informed about regulatory changes and industry best practices in clinical research.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field. Advanced degree preferred.
- Minimum of 5-7 years of experience as a Clinical Research Associate (CRA) or in a similar clinical trial management role.
- Thorough understanding of ICH-GCP guidelines and applicable regulatory requirements.
- Demonstrated experience in site monitoring, data verification, and regulatory compliance.
- Excellent organizational, time management, and problem-solving skills.
- Strong interpersonal and communication skills, with the ability to build rapport with site personnel and internal teams.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to study sites as required.
- Adaptability to work effectively in a hybrid work environment, balancing remote tasks with on-site responsibilities.
This advertiser has chosen not to accept applicants from your region.
5
Senior Clinical Research Associate (CRA)
500081 Hyderabad, Andhra Pradesh
₹110000 Annually
WhatJobs
Posted 5 days ago
Job Viewed
Job Description
Our client is seeking a highly experienced and dedicated Senior Clinical Research Associate (CRA) to oversee and manage clinical trials in accordance with established protocols and regulatory guidelines. This role is crucial for ensuring the integrity, accuracy, and reliability of clinical trial data, contributing to the development of life-saving therapies. The ideal candidate will possess extensive knowledge of Good Clinical Practice (GCP), clinical trial monitoring techniques, and regulatory requirements. A strong ability to build rapport with investigators, site staff, and internal teams is essential. This hybrid role offers the flexibility to balance remote work with necessary on-site visits.
Responsibilities:
Qualifications:
This hybrid role, servicing Hyderabad, Telangana, IN , offers a compelling opportunity to contribute to groundbreaking pharmaceutical research while maintaining a flexible work-life balance.
Responsibilities:
- Conduct site initiation, monitoring, and close-out visits for clinical trials according to protocol, GCP, and regulatory requirements.
- Ensure the rights, safety, and well-being of study participants are protected.
- Verify that study conduct is in compliance with the Investigational Plan, protocol amendments, and applicable regulations.
- Monitor the accuracy, completeness, and quality of study data.
- Manage assigned clinical sites, ensuring efficient study conduct and timely data collection.
- Resolve site-level issues and deviations promptly and effectively.
- Train and support investigators and site staff on study procedures, data collection, and regulatory compliance.
- Prepare and present site status reports to internal teams and management.
- Ensure timely submission of all required regulatory documentation.
- Maintain accurate and complete study documentation and site files.
- Collaborate with project managers, data managers, and other study personnel.
- Identify and report Adverse Events (AEs) and Serious Adverse Events (SAEs) according to protocol.
- Ensure drug accountability and accurate dispensing records are maintained at sites.
- Participate in Investigator Meetings and other study-related team meetings.
- Contribute to the development of clinical study protocols and other study documents.
Qualifications:
- Bachelor's degree in a life science, nursing, pharmacy, or related discipline.
- Minimum of 5-7 years of experience as a Clinical Research Associate.
- Thorough understanding and application of ICH-GCP guidelines and other relevant regulatory requirements (e.g., FDA, EMA).
- Proven experience in site monitoring, data review, and issue resolution.
- Excellent communication, interpersonal, and organizational skills.
- Ability to work independently and manage multiple priorities effectively.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Strong attention to detail and a commitment to data integrity.
- Ability to travel to clinical sites as required (up to 50% may be expected).
- Experience in specific therapeutic areas is a plus.
- Certification from ACRP or SoCRA is desirable.
- Comfortable using technology for remote communication and documentation.
This hybrid role, servicing Hyderabad, Telangana, IN , offers a compelling opportunity to contribute to groundbreaking pharmaceutical research while maintaining a flexible work-life balance.
This advertiser has chosen not to accept applicants from your region.
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6
Senior Clinical Research Associate (CRA)
500081 Hyderabad, Andhra Pradesh
₹90000 Annually
WhatJobs
Posted 10 days ago
Job Viewed
Job Description
Our client is seeking a highly motivated and experienced Senior Clinical Research Associate (CRA) to join their dynamic pharmaceutical team in **Hyderabad, Telangana, IN**. This role is pivotal in ensuring the successful execution of clinical trials, adhering strictly to Good Clinical Practice (GCP) guidelines and regulatory requirements. The Senior CRA will be responsible for the comprehensive management and monitoring of clinical trial sites. Key responsibilities include site initiation, regular monitoring visits (both on-site and remote), ensuring accurate and timely data collection, and managing investigational product accountability. You will also play a crucial role in resolving site-specific issues, facilitating communication between the sponsor and the investigators, and ensuring patient safety and data integrity. The ideal candidate will possess a strong understanding of clinical trial phases, study protocols, and therapeutic areas. Furthermore, you will be expected to train and mentor junior CRAs, contributing to the overall growth and expertise of the clinical operations department. This hybrid role requires flexibility, with a blend of remote work and on-site presence at our **Hyderabad, Telangana, IN** office, as well as travel to clinical trial sites. We are looking for an individual with excellent organizational, interpersonal, and problem-solving skills. A bachelor's degree in a life science, nursing, or a related field is required, with a Master's degree being a significant advantage. A minimum of 5-7 years of direct CRA experience is essential, along with a proven track record of successfully managing multiple trials simultaneously. Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems is a must. The ability to adapt to evolving trial needs and a commitment to continuous learning are highly valued. Join us in advancing pharmaceutical research and making a tangible impact on patient lives from our **Hyderabad, Telangana, IN** hub.
This advertiser has chosen not to accept applicants from your region.
7
Lead Clinical Research Associate (CRA)
500001 Hyderabad, Andhra Pradesh
₹90000 Annually
WhatJobs
Posted 17 days ago
Job Viewed
Job Description
Join our innovative pharmaceutical company as a Lead Clinical Research Associate (CRA) in a fully remote capacity, contributing to groundbreaking drug development initiatives. This senior role is crucial for ensuring the successful execution and integrity of clinical trials across various therapeutic areas. As the Lead CRA, you will provide expert oversight and mentorship to a team of CRAs, ensuring adherence to Good Clinical Practice (GCP) guidelines, regulatory requirements, and study protocols. Your responsibilities will include developing and managing clinical trial budgets, leading site selection and initiation visits, monitoring study progress, and ensuring data accuracy and completeness. You will serve as the primary point of contact for clinical trial sites, investigators, and internal project teams, fostering strong collaborative relationships. The ideal candidate possesses a Bachelor's or Master's degree in a life science or healthcare-related field, combined with extensive experience (minimum 8 years) as a Clinical Research Associate, with at least 3 years in a lead or supervisory capacity. Proven experience in managing complex multi-center clinical trials and a thorough understanding of regulatory submissions and compliance are mandatory. Exceptional communication, leadership, and problem-solving skills are essential for effectively managing a remote team and diverse stakeholders. You must be proficient in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems. This remote position requires a high degree of self-motivation, excellent organizational skills, and the ability to travel as needed for site visits or critical meetings. We are seeking a highly motivated professional dedicated to advancing patient care through rigorous scientific research and clinical excellence. Your expertise will be vital in bringing life-changing therapies to market. This role is based in Hyderabad, Telangana, IN , but operates entirely remotely.
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8
Senior Clinical Research Associate - Remote
500001 Hyderabad, Andhra Pradesh
₹90000 Monthly
WhatJobs
Posted 18 days ago
Job Viewed
Job Description
Our client is seeking a highly experienced and dedicated Senior Clinical Research Associate (CRA) to join our fully remote clinical operations team. This critical role involves overseeing and managing clinical trials at various research sites, ensuring adherence to protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. As a remote Senior CRA, you will be responsible for remote monitoring of study sites, conducting virtual source data verification, and providing essential support to investigators and site staff. Your expertise will be vital in ensuring the integrity, accuracy, and timeliness of clinical trial data. You will conduct remote pre-study visits, initiation visits, routine monitoring visits (where applicable remotely), and close-out visits, all while maintaining comprehensive documentation. A strong understanding of therapeutic areas, drug development processes, and regulatory frameworks is essential. You will build and maintain strong relationships with clinical investigators and site personnel, fostering a collaborative and effective research environment. This position demands exceptional organizational skills, meticulous attention to detail, and outstanding communication abilities. The ability to work autonomously, manage your time effectively, and adapt to the evolving needs of clinical trials in a remote setting is paramount. You will be expected to identify potential risks and issues at study sites and implement corrective and preventive actions proactively. We are looking for a candidate who is passionate about advancing medical research and committed to upholding the highest standards of clinical trial conduct. This is an excellent opportunity to contribute your skills to groundbreaking pharmaceutical research from the comfort of your home. The **Hyderabad, Telangana** region, while not your physical workspace, is where our client's primary research and development hubs are located, and your contributions will directly impact their pharmaceutical pipeline. Responsibilities:
- Perform remote monitoring of clinical trial sites to ensure compliance with protocols, GCP, and regulatory guidelines.
- Conduct virtual source data verification and review study documentation remotely.
- Ensure accurate and timely data collection and reporting.
- Build and maintain strong relationships with investigators, site staff, and study sponsors.
- Provide training and ongoing support to clinical site personnel.
- Identify, assess, and resolve study-related issues and deviations.
- Prepare and deliver comprehensive monitoring visit reports.
- Ensure all study-related documentation is accurate, complete, and archived appropriately.
- Contribute to the development and refinement of clinical trial protocols and study plans.
- Stay updated on relevant therapeutic areas, clinical research trends, and regulatory changes.
- Manage multiple clinical trials and sites simultaneously.
- Uphold the highest ethical standards in all aspects of clinical research.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Advanced degree preferred.
- Minimum of 5 years of experience as a Clinical Research Associate.
- Extensive knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
- Proven experience in remote monitoring and virtual site management.
- Strong understanding of various therapeutic areas.
- Excellent communication, interpersonal, and organizational skills.
- Ability to work independently and manage time effectively in a remote setting.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Detail-oriented with strong analytical and problem-solving abilities.
This advertiser has chosen not to accept applicants from your region.
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