1,108 Clinical Study jobs in India

Clinical Study Report (Csr) Writer

Bengaluru, Karnataka Apotex Research Private Limited

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**About Apotex Inc.**

**Job Summary**:
Responsible for execution of the study and system related activities as per the established Standard Operating Procedures (SOP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and regulatory requirements.

**Responsibilities**:

- Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Center’s Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures.
- Entry of the study data in the required formats / data base for report table preparation and CDISC datasets preparation.
- Performs the collection, recording, retrieval of information, verify the accuracy of the information, manage data storage and retrieval systems.
- Review of report tables.
- Performs the activities related to requisition, receiving and accountability of the forms for the study.
- Ensure readiness of the department to face regulatory audit by following good documentation practices, GCP & relevant SOPs.
- Organizing files and collecting clinical data to be entered into the databases or in required formats.
- Assists in reconciliation of the study data.
- Coordinates / communicates internal and / or with cross functional departments for study relevant activities.
- Perform study activities as per the study specific protocol requirements and other duties as assigned by the Clinical Operations Management/delegate as training and experience allow.
- Responsible for handling (receiving, Issuing, Storage etc.,) of Clinical Study Materials in stores.
- Performs work in accordance with all established regulatory, compliance and safety requirements.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.

**Job Requirements**:

- Education
- B.Pharm / Pharm D / B.Sc. in Life Science related filed.
- Knowledge, Skills and Abilities
- Good skills in MS Office.
- Good in Communication skills.
- Flexible to work
- Experience
- 0-2 years in Clinical Reasearch

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
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Clinical Research Associate

400601 Thane, Maharashtra ₹60000 month WhatJobs

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full-time
Are you a detail-oriented and experienced professional in the pharmaceutical or clinical research field? Our client, a leading pharmaceutical company dedicated to advancing healthcare, is seeking a motivated Clinical Research Associate (CRA) to join their team in Thane, Maharashtra, IN . This role offers a hybrid working model, combining the benefits of remote flexibility with essential on-site collaboration. As a CRA, you will play a crucial role in ensuring the quality and integrity of clinical trials by monitoring study sites, verifying data accuracy, and ensuring compliance with protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. You will be responsible for site selection, initiation, monitoring, and close-out activities, building strong relationships with investigators and site staff. Your key duties will include reviewing patient records, ensuring proper documentation, and reporting trial progress. The ideal candidate will possess a strong understanding of clinical trial processes, excellent organizational and communication skills, and the ability to travel to study sites as needed. A background in life sciences, nursing, or a related field, coupled with prior experience as a CRA or in a clinical research support role, is essential. We are looking for individuals who are proactive, analytical, and committed to upholding the highest ethical and scientific standards. This is an excellent opportunity to contribute to the development of life-saving therapies and grow your career within a reputable organization. If you are driven by a passion for medical advancement and possess the required skills and experience, we encourage you to apply.
Key Responsibilities:
  • Conduct site selection, initiation, interim monitoring, and close-out visits.
  • Ensure adherence to protocols, SOPs, GCP, and regulatory requirements at study sites.
  • Verify the accuracy, completeness, and integrity of clinical data.
  • Manage communication and relationships with investigators and site staff.
  • Train site personnel on study procedures and protocols.
  • Review essential documents and regulatory binders.
  • Prepare monitoring reports and track action items.
  • Identify and escalate site-level issues and risks.
  • Participate in investigator meetings and provide feedback.
  • Ensure timely submission of study-related documentation.
Qualifications:
  • Proven experience as a Clinical Research Associate (CRA) or similar role.
  • In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
  • Experience with clinical trial monitoring and site management.
  • Strong understanding of medical terminology and clinical research processes.
  • Excellent attention to detail and organizational skills.
  • Proficiency in data management and electronic data capture (EDC) systems.
  • Strong written and verbal communication skills.
  • Ability to travel to sites as required.
  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
  • Working knowledge of study documentation and regulatory submissions.
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Clinical Research Associate

500001 Shaikpet, Andhra Pradesh ₹70000 Annually WhatJobs

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full-time
Our client, a prominent pharmaceutical company, is looking for a meticulous and experienced Clinical Research Associate (CRA) to join their team. This role is integral to the successful execution of clinical trials, ensuring adherence to protocols, regulatory requirements, and ethical standards. You will be responsible for monitoring trial sites, collecting data, and ensuring the safety and well-being of trial participants. This is a hybrid position, offering a balance of remote work and essential on-site monitoring activities at clinical trial locations in and around **Hyderabad, Telangana, IN**.

Key Responsibilities:
  • Monitor clinical trial sites to ensure compliance with protocols, SOPs, and regulatory guidelines (e.g., GCP, ICH).
  • Verify the accuracy, completeness, and integrity of clinical trial data.
  • Perform source data verification (SDV) and review source documents.
  • Manage communication between investigators, site staff, and the sponsor.
  • Ensure timely submission of required study documents and reports.
  • Oversee the recruitment and enrollment of study participants.
  • Train site staff on study protocols and procedures.
  • Identify and report adverse events and deviations from protocol.
  • Conduct site initiation, monitoring, and close-out visits.
  • Maintain organized and up-to-date trial documentation and site files.
  • Collaborate with clinical operations teams and data management.
  • Ensure the safety and rights of study participants are protected.
Qualifications:
  • Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field. Advanced degree is a plus.
  • Minimum of 3-5 years of experience as a Clinical Research Associate or in a similar role.
  • In-depth knowledge of clinical trial processes, GCP, and regulatory requirements.
  • Excellent monitoring, data collection, and documentation skills.
  • Strong understanding of medical terminology and disease states.
  • Effective communication, interpersonal, and organizational abilities.
  • Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
  • Ability to travel to clinical sites as required for monitoring.
  • Strong analytical and problem-solving skills.
  • Commitment to ethical research practices.
This hybrid role is based in **Hyderabad, Telangana, IN**, offering a dynamic career opportunity within the pharmaceutical sector. Join our client and contribute to the advancement of life-saving treatments.
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Clinical Research Associate

208001 Kanpur, Uttar Pradesh ₹800000 Annually WhatJobs

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full-time
Our client, a global pharmaceutical company, is seeking a diligent and experienced Clinical Research Associate (CRA) to support their ongoing clinical trials. This hybrid role involves regular site visits to hospitals and research centers in and around Kanpur, Uttar Pradesh , balanced with remote work for data management, reporting, and coordination. You will play a vital role in ensuring the quality and integrity of clinical trial data.

Key Responsibilities:
  • Monitor clinical trial sites to ensure adherence to Good Clinical Practice (GCP), protocols, and regulatory requirements.
  • Verify the accuracy, completeness, and validity of clinical data collected at study sites.
  • Conduct site initiation visits, routine monitoring visits, and close-out visits.
  • Manage communication between investigative sites and the study team.
  • Train site staff on study protocols, procedures, and data collection requirements.
  • Ensure the proper handling and storage of investigational products and study-related materials.
  • Identify, document, and resolve site-specific issues and deviations.
  • Prepare monitoring reports and follow up on action items with site personnel.
  • Facilitate drug accountability and maintain study documentation at investigator sites.
  • Collaborate with study statisticians, data managers, and medical monitors.
  • Ensure timely submission of all required study documents to regulatory authorities and ethics committees.
  • Contribute to the development and review of study protocols and case report forms (CRFs).
Qualifications:
  • Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field. A Master's degree is preferred.
  • Minimum of 3 years of experience as a Clinical Research Associate or in a similar role within the pharmaceutical or biotech industry.
  • In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.
  • Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
  • Strong understanding of medical terminology and clinical trial processes.
  • Excellent organizational skills, attention to detail, and ability to manage multiple priorities.
  • Proficient in Microsoft Office Suite, particularly Word, Excel, and PowerPoint.
  • Effective communication and interpersonal skills, with the ability to build strong relationships with site staff.
  • Ability to travel frequently to clinical sites and work effectively in a hybrid environment.
  • Problem-solving skills and the ability to work independently with minimal supervision.
  • Experience in oncology or cardiovascular clinical trials is a significant advantage.
Join our client's team and contribute to the advancement of life-saving therapies through rigorous clinical research, with a flexible hybrid working model.
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Clinical Research Associate

226001 Lucknow, Uttar Pradesh ₹75000 Annually WhatJobs

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full-time
Our client, a rapidly growing pharmaceutical company, is seeking a meticulous and experienced Clinical Research Associate (CRA) to join their team in Lucknow, Uttar Pradesh . This role plays a vital part in ensuring the successful execution of clinical trials, adhering strictly to regulatory guidelines and protocols. The ideal candidate will be responsible for monitoring clinical trial sites, ensuring data accuracy, patient safety, and overall compliance with Good Clinical Practice (GCP) standards. Key responsibilities include site initiation visits, routine monitoring visits, and site closure visits. You will review patient records, source documents, and case report forms (CRFs) to verify data integrity. The CRA will also liaise with investigators and site staff, providing training and support as needed, and resolving any discrepancies or issues that arise. Effective communication and problem-solving skills are essential for managing relationships with multiple stakeholders. Travel to clinical trial sites will be a necessary component of this role, balanced with remote administrative tasks. Staying updated on evolving regulatory requirements and industry best practices is crucial. This position offers a compelling opportunity to contribute to the advancement of medical research and the development of life-saving therapies within a dynamic and professional setting. The successful applicant will demonstrate a strong commitment to ethical research conduct and patient well-being.
Key Qualifications:
  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
  • Minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical trial role.
  • In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
  • Experience with clinical trial monitoring, site management, and data verification.
  • Strong understanding of medical terminology and clinical research processes.
  • Excellent communication, organizational, and time management skills.
  • Ability to travel to sites as required.
  • Proficiency in clinical trial management software and EDC systems is a plus.

If you are passionate about clinical research and possess the required expertise, we encourage you to apply.
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Clinical Research Associate

160001 Chandigarh, Chandigarh ₹75000 Annually WhatJobs

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full-time
Our client, a leading pharmaceutical company, is seeking a dedicated and detail-oriented Clinical Research Associate (CRA) to join their growing research team. This is a fully remote position, offering the flexibility to conduct essential research activities from anywhere in India. As a CRA, you will play a critical role in overseeing and managing clinical trials, ensuring adherence to protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. You will be responsible for site selection, initiation, monitoring, and close-out visits, as well as data collection and management. Your primary focus will be to ensure the safety and integrity of study participants and the accuracy of the data collected.

Key responsibilities include developing and finalizing clinical trial protocols, managing study documentation, and providing training to study site staff. You will serve as the main point of contact for investigators and study sites, addressing any queries or issues that arise during the trial. The role involves extensive travel to clinical sites across various regions, although the core responsibilities and management are conducted remotely. You will review source documents, electronic data capture (EDC) systems, and investigational product accountability to ensure data quality and compliance. This position requires strong organizational skills, meticulous attention to detail, and the ability to work independently while collaborating effectively with cross-functional teams. We are looking for an individual passionate about advancing medical research and committed to upholding the highest standards of ethical conduct and scientific rigor. Join our client and contribute to bringing life-changing therapies to patients.

Qualifications:
  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
  • Minimum of 3 years of experience as a Clinical Research Associate or in a similar role within the pharmaceutical industry.
  • In-depth knowledge of clinical trial processes, ICH-GCP guidelines, and regulatory requirements.
  • Experience with EDC systems and clinical trial management software.
  • Excellent communication, interpersonal, and problem-solving skills.
  • Ability to manage multiple priorities and meet strict deadlines in a remote work environment.
  • Willingness to travel as required for site visits.
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Clinical Research Associate

682001 Kochi, Kerala ₹850000 Annually WhatJobs

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full-time
Our client, a leading pharmaceutical company, is actively recruiting a skilled Clinical Research Associate (CRA) to join their esteemed team in Kochi, Kerala . This role is integral to the successful execution of clinical trials, ensuring that they are conducted, recorded, and reported in accordance with protocol, standard operating procedures, and applicable regulatory requirements. The CRA will be responsible for site selection, initiation, monitoring, and close-out visits. You will ensure that study protocols are adhered to, patient safety is maintained, and data integrity is upheld throughout the trial.

Key responsibilities include verifying data accuracy, managing investigational product, and ensuring compliance with Good Clinical Practice (GCP) guidelines. The CRA will build and maintain strong working relationships with clinical investigators and site staff, providing training and support as needed. Excellent written and verbal communication skills are essential for preparing monitoring reports, communicating with regulatory authorities, and collaborating with internal teams. The ideal candidate will possess a strong understanding of clinical trial processes, regulatory affairs, and medical terminology. A meticulous approach to documentation and a commitment to quality are paramount. This is an excellent opportunity for a dedicated professional to contribute to the development of life-saving medicines and advance their career in the dynamic pharmaceutical industry. We are looking for an individual who is proactive, detail-oriented, and capable of managing multiple priorities in a challenging yet rewarding environment.
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Clinical Research Associate

751001 Bhubaneswar, Orissa ₹60000 month WhatJobs

Posted 1 day ago

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full-time
Our client is seeking a diligent and experienced Clinical Research Associate (CRA) to join their pharmaceutical team in Bhubaneswar. This hybrid role requires a blend of on-site presence for essential clinical trial activities and remote work for data management and reporting. As a CRA, you will play a pivotal role in ensuring the successful execution of clinical trials, adhering strictly to Good Clinical Practice (GCP) guidelines and regulatory requirements. Your responsibilities will include site initiation, monitoring, and close-out visits, verifying the accuracy and completeness of source data, and ensuring patient safety and data integrity. You will be the primary point of contact for investigative sites, providing training and support to clinical site staff. This position demands meticulous attention to detail, strong organizational skills, and the ability to manage multiple projects simultaneously. The ideal candidate will possess a solid understanding of drug development processes and clinical trial protocols.

Key responsibilities:
  • Conduct pre-study, initiation, routine monitoring, and close-out visits for assigned clinical trial sites.
  • Verify the accuracy, completeness, and quality of clinical data by comparing source documents with case report forms (CRFs).
  • Ensure compliance with the study protocol, investigational plan, FDA regulations, and Good Clinical Practice (GCP) guidelines.
  • Manage and resolve data discrepancies and queries in a timely manner.
  • Provide training and ongoing support to site personnel, including investigators and study coordinators.
  • Monitor site progress, identify potential issues, and implement corrective actions as needed.
  • Maintain essential trial documentation and regulatory files.
  • Communicate effectively with study teams, investigators, and relevant stakeholders.
  • Prepare visit reports and other necessary documentation.

Qualifications:
  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
  • Minimum of 3 years of experience as a Clinical Research Associate.
  • Thorough knowledge of ICH-GCP guidelines and regulatory requirements.
  • Experience in monitoring clinical trials across various therapeutic areas.
  • Strong understanding of clinical trial processes and documentation.
  • Excellent communication, interpersonal, and problem-solving skills.
  • Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
  • Ability to travel to clinical sites as required for monitoring activities.
  • Detail-oriented with strong organizational and time management skills.
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Clinical Research Associate

600001 Chennai, Tamil Nadu ₹80000 Annually WhatJobs

Posted 1 day ago

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full-time
Our client, a leading pharmaceutical company, is seeking a dedicated Clinical Research Associate (CRA) to join their growing team. This role is primarily based in **Chennai, Tamil Nadu**, requiring regular site visits. As a CRA, you will play a vital role in ensuring the quality and integrity of clinical trials by monitoring study conduct at investigative sites. Your responsibilities will include verifying data, ensuring compliance with protocols and regulations, and managing relationships with study personnel. This is a critical position for ensuring the successful development of new pharmaceutical products.
Responsibilities:
  • Monitor clinical trial sites to ensure adherence to protocol, GCP guidelines, and regulatory requirements.
  • Verify accuracy and completeness of clinical data through source document verification.
  • Manage site communications and resolve issues that may arise during the trial.
  • Conduct site initiation visits, interim monitoring visits, and close-out visits.
  • Ensure proper drug accountability and storage at investigative sites.
  • Train study site staff on study procedures and regulatory requirements.
  • Prepare monitoring reports and follow up on action items.
  • Collaborate with study teams to ensure timely enrollment and data collection.
  • Maintain updated knowledge of regulatory requirements and company policies.
  • Ensure the safety and rights of study participants are protected.

Qualifications:
  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field.
  • Minimum of 2 years of experience as a Clinical Research Associate or in a similar role.
  • In-depth knowledge of ICH-GCP guidelines and regulatory requirements.
  • Strong understanding of clinical trial processes and documentation.
  • Excellent monitoring and auditing skills.
  • Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
  • Exceptional attention to detail and accuracy.
  • Strong organizational and time management skills.
  • Excellent written and verbal communication skills.
  • Ability to travel to clinical sites as required.

This role offers a competitive compensation package and the opportunity to contribute to groundbreaking medical research.
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Clinical Research Associate

695001 Thiruvananthapuram, Kerala ₹75000 Annually WhatJobs

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full-time
Our client, a leading pharmaceutical innovator, is seeking a meticulous and driven Clinical Research Associate (CRA) to join their team in Thiruvananthapuram, Kerala, IN . This hybrid role involves monitoring clinical trials to ensure data accuracy, patient safety, and adherence to regulatory guidelines. You will be responsible for site initiation, routine monitoring, and close-out visits, ensuring all study-related activities are conducted in accordance with protocols, Good Clinical Practice (GCP), and applicable regulations. Your role will include reviewing and verifying case report forms (CRFs), source documents, and other study records, as well as managing investigational product accountability. Effective communication with investigators, site staff, and internal project teams is crucial.

The successful candidate will possess a strong understanding of clinical trial processes and regulatory requirements within the pharmaceutical industry. You will be adept at identifying and resolving issues that arise during trial conduct, ensuring the integrity of the study data. This position requires excellent organizational skills, attention to detail, and the ability to manage multiple projects simultaneously. The hybrid nature of this role means you will spend a significant portion of your time at clinical trial sites, with the remaining time working remotely. This offers a blend of hands-on site interaction and the flexibility of remote work. You will be expected to travel to sites as needed, typically within the region.

Key responsibilities include conducting pre-study visits, site initiation visits, routine monitoring visits, and close-out visits. You will also be responsible for preparing monitoring reports, maintaining study documentation, and ensuring compliance with all study-related procedures. The ideal candidate will have a Bachelor's degree in a life science, nursing, or related field, with a minimum of 3 years of experience as a CRA or in a similar clinical research role. Knowledge of ICH-GCP guidelines and experience with electronic data capture (EDC) systems are essential. Strong written and verbal communication skills are required, along with proficiency in Microsoft Office Suite. Join our client's dedicated team and contribute to the advancement of life-saving therapies.
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