722 Senior Cra jobs in India
Clinical Research Associate (CRA)
Posted today
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The ideal candidate will possess a strong understanding of clinical trial processes, regulatory guidelines (GCP, ICH), and medical terminology. You will conduct site initiation visits, interim monitoring visits, and close-out visits. Your responsibilities include training site staff on study protocols, managing study supplies, and resolving data queries. Exceptional organizational skills, attention to detail, and the ability to manage time effectively are essential for this demanding role. You will communicate regularly with investigators, study coordinators, and internal project teams. This position requires a high degree of autonomy and the ability to work independently while maintaining strong collaborative relationships. Travel may be required for site visits, but the core operations and support are managed remotely.
Responsibilities:
- Monitor clinical trial sites to ensure adherence to protocols and GCP guidelines.
- Verify the accuracy, completeness, and integrity of clinical trial data.
- Conduct site initiation, interim monitoring, and close-out visits.
- Train and support site personnel on study requirements and procedures.
- Ensure compliance with regulatory requirements and ethical standards.
- Manage study documentation and regulatory binders.
- Identify and resolve site issues and deviations.
- Communicate effectively with investigators, study coordinators, and study teams.
- Oversee drug accountability and sample collection procedures.
- Prepare monitoring visit reports and follow up on action items.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, 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.
- In-depth knowledge of clinical trial processes and regulatory guidelines (GCP, ICH).
- Excellent understanding of medical terminology and therapeutic areas.
- Strong analytical, problem-solving, and organizational skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Excellent written and verbal communication skills.
- Ability to travel to sites as needed (up to X% - adjust as appropriate).
- Proven ability to work independently and manage workload effectively.
- Detail-oriented with a commitment to data quality and patient safety.
Clinical Research Associate (CRA)
Posted today
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Job Description
As a CRA, you will be instrumental in ensuring the smooth execution and integrity of clinical trials. Your primary responsibilities will involve monitoring investigational sites to verify adherence to protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. You will conduct site qualification, initiation, interim monitoring, and close-out visits, ensuring all study-related documentation is accurate, complete, and filed appropriately. This includes reviewing source documents, case report forms (CRFs), and drug accountability records. You will also serve as the main point of contact between the sponsor and the investigational sites, fostering strong relationships and addressing any issues or queries that arise promptly and effectively.
Key Responsibilities:
- Perform site visits (qualification, initiation, routine monitoring, close-out) according to the Clinical Monitoring Plan.
- Verify the rights and well-being of study subjects.
- Ensure the accuracy, completeness, and quality of study data through source data verification.
- Monitor compliance with the study protocol, SOPs, GCP, and applicable regulatory requirements.
- Maintain regulatory binders and essential study documents at the site and in the sponsor's files.
- Communicate effectively with investigators, site staff, and study team members.
- Identify and report adverse events (AEs) and serious adverse events (SAEs) in a timely manner.
- Prepare visit reports and follow-up on action items.
- Assist in the recruitment and retention of study participants.
- Contribute to the training of site personnel on study procedures.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Proven experience as a Clinical Research Associate or in a similar clinical research role.
- In-depth knowledge of ICH-GCP guidelines and local regulatory requirements.
- Excellent understanding of clinical trial processes and documentation.
- Strong attention to detail and organizational skills.
- Exceptional interpersonal and communication skills, both written and verbal.
- Ability to travel to investigational sites as required.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Problem-solving abilities and a proactive approach to identifying and resolving issues.
Clinical Research Associate (CRA)
Posted today
Job Viewed
Job Description
Clinical Research Associate (CRA)
Posted today
Job Viewed
Job Description
Responsibilities:
- Monitor clinical trial activities at assigned investigative sites.
- Ensure compliance with study protocols, GCP, and regulatory requirements.
- Verify the accuracy, completeness, and integrity of clinical data.
- Conduct site initiation, interim monitoring, and close-out visits.
- Review essential trial documents and regulatory binders.
- Communicate effectively with investigators, study coordinators, and site staff.
- Identify and resolve site-level issues and discrepancies.
- Report on study progress, risks, and potential issues to management.
- Ensure proper handling and reporting of adverse events.
- Train site personnel on study procedures and requirements.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
- Minimum of 3 years of experience as a Clinical Research Associate (CRA) or in a similar clinical trial monitoring role.
- In-depth knowledge of ICH-GCP guidelines and clinical trial regulations.
- Experience with clinical trial monitoring tools and electronic data capture (EDC) systems.
- Excellent organizational, time management, and problem-solving skills.
- Strong attention to detail and accuracy.
- Ability to travel to clinical sites as required.
- Excellent interpersonal and communication skills.
- Ability to work independently and as part of a team.
- Knowledge of medical terminology and clinical procedures.
Clinical Research Associate (CRA)
Posted 2 days ago
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Job Description
Responsibilities:
- Monitor clinical trial sites to ensure compliance with protocols, SOPs, and regulatory requirements.
- Verify the accuracy, completeness, and consistency of clinical data.
- Conduct site initiation, interim, and close-out visits.
- Ensure proper Investigational Product (IP) accountability and management.
- Build and maintain strong working relationships with principal investigators and study coordinators.
- Identify, evaluate, and recommend new study sites.
- Resolve issues identified during site visits and track their resolution.
- Prepare and present monitoring reports in a timely manner.
- Ensure timely drug and clinical supply delivery to sites.
- Maintain accurate and up-to-date trial documentation.
- Participate in Investigator meetings and provide training to site personnel.
- Contribute to the development and review of study-related documents, such as protocols and case report forms (CRFs).
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related scientific discipline.
- Minimum of 3-5 years of direct experience as a Clinical Research Associate.
- Thorough understanding of ICH-GCP guidelines and regulatory requirements.
- Experience with various therapeutic areas is an asset.
- Proficiency in clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
- Excellent written and verbal communication skills.
- Strong organizational and time management abilities.
- Ability to travel frequently to study sites (approximately 50-60% travel).
- Detail-oriented with a high level of accuracy.
- Problem-solving skills and the ability to work independently.
- Valid driver's license and passport for travel.
Clinical Research Associate (CRA)
Posted 5 days ago
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Job Description
Responsibilities:
- Monitor clinical trial sites to ensure adherence to protocols, SOPs, and regulatory requirements (e.g., GCP, FDA).
- Verify the accuracy, completeness, and integrity of clinical trial data through source document verification.
- Ensure proper informed consent procedures are followed and that all study-related documentation is accurate and up-to-date.
- Act as the primary liaison between study sites and the sponsor company, addressing site staff queries and issues.
- Train site personnel on study-specific procedures and regulatory requirements.
- Conduct pre-study, initiation, interim, and close-out visits at clinical trial sites.
- Manage site issues and ensure timely resolution.
- Review and approve site budgets and payments.
- Prepare monitoring visit reports and follow up on action items.
- Ensure the safety and well-being of study participants.
- Contribute to the development of study protocols and other study-related documents.
- Maintain effective communication with investigators, study coordinators, and other study personnel.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Master's degree preferred.
- Minimum of 3-5 years of experience as a Clinical Research Associate or in a similar clinical trial management role.
- In-depth knowledge of Good Clinical Practice (GCP) guidelines and other relevant regulatory requirements.
- Strong understanding of clinical trial processes and methodologies.
- Excellent monitoring, data verification, and problem-solving skills.
- Exceptional organizational, time management, and communication skills.
- Ability to travel to study sites as required.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Detail-oriented with a commitment to accuracy and compliance.
Clinical Research Associate (CRA)
Posted 7 days ago
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Job Description
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Clinical Research Associate (CRA)
Posted 9 days ago
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Job Description
- Conduct pre-study, initiation, monitoring, and close-out visits for clinical trial sites.
- Ensure compliance with study protocols, Standard Operating Procedures (SOPs), and regulatory guidelines (GCP, ICH).
- Verify the accuracy, completeness, and integrity of clinical trial data by reviewing source documents.
- Monitor patient safety and report adverse events and serious adverse events promptly.
- Train and support site staff on study-specific procedures and requirements.
- Build and maintain strong working relationships with principal investigators and study coordinators.
- Resolve data discrepancies and ensure timely query resolution.
- Manage site supplies and ensure proper storage and handling of investigational products.
- Prepare and submit monitoring visit reports in a timely manner.
- Participate in investigator meetings and training sessions.
- Ensure site regulatory binders are complete and up-to-date.
- 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 related clinical research role.
- In-depth knowledge of GCP, ICH guidelines, and other relevant regulatory requirements.
- Proven experience in conducting site monitoring visits and data verification.
- Excellent understanding of clinical trial processes and documentation.
- Strong organizational, time management, and problem-solving skills.
- Exceptional written and verbal communication and interpersonal skills.
- Ability to travel to clinical trial sites as required.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems is a plus.
- A commitment to maintaining the highest ethical standards in clinical research.
Clinical Research Associate (CRA)
Posted 9 days ago
Job Viewed
Job Description
Responsibilities:
- Conduct pre-study, initiation, routine, and close-out visits to clinical trial sites.
- Monitor study conduct to ensure adherence to the clinical protocol, GCP, and regulatory requirements.
- Verify the accuracy, completeness, and integrity of clinical data through source data verification (SDV).
- Ensure proper documentation and maintenance of Trial Master File (TMF).
- Assess patient safety and report adverse events and serious adverse events according to protocol.
- Manage investigational product accountability at study sites.
- Train site personnel on study procedures and protocol requirements.
- Build and maintain strong working relationships with investigators and study coordinators.
- Prepare monitoring reports and follow up on action items.
- Identify site issues and escalate them to the Clinical Operations Manager as needed.
- Contribute to the development of study-related documents, such as protocols and case report forms.
- Ensure timely submission of essential documents.
- Communicate effectively with internal teams, including project managers, data managers, and medical monitors.
- Travel to study sites as required by the study protocol and business needs.
- Stay updated on regulatory guidelines and industry best practices.
- 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.
- In-depth knowledge of ICH-GCP guidelines and relevant regulatory requirements.
- Proven experience in monitoring clinical trials across various therapeutic areas.
- Excellent understanding of clinical trial processes, from initiation to close-out.
- Strong medical knowledge and ability to interpret clinical data.
- Exceptional attention to detail and accuracy.
- Outstanding written and verbal communication skills.
- Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Ability to work independently, manage multiple priorities, and meet deadlines.
- Willingness to travel to sites and work in a hybrid model.
- Good problem-solving and critical thinking abilities.
Clinical Research Associate (CRA)
Posted 11 days ago
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Job Description
Responsibilities:
- Identify, evaluate, and select potential clinical trial sites.
- Initiate, monitor, and close-out clinical trial sites according to protocol, GCP, and regulatory requirements.
- Conduct pre-study, initiation, interim, and close-out monitoring visits as required.
- Verify the accuracy, completeness, and validity of clinical data collected at study sites.
- Ensure adherence to the study protocol, informed consent procedures, and regulatory guidelines.
- Train site staff on study procedures, data collection, and regulatory requirements.
- Manage site-level issues and deviations, escalating when necessary.
- Maintain study documentation and ensure the site regulatory binder is up-to-date.
- Build and maintain strong relationships with investigators and site staff.
- Report on site performance and identify risks and mitigation strategies.
- Participate in Investigator Meetings and provide training to site personnel.
- Oversee drug accountability and ensure proper storage and dispensing.
- Prepare monitoring reports and communicate findings to the study team.
- Ensure timely data entry and query resolution by the site.
- Stay current with industry best practices and regulatory changes affecting clinical research.
- 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 monitoring role.
- Thorough understanding of ICH-GCP guidelines and local regulatory requirements.
- Experience with various therapeutic areas is a plus.
- Excellent organizational, time management, and problem-solving skills.
- Strong written and verbal communication abilities.
- Proficiency in using clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
- Ability to travel to sites as required (estimated 40-60% travel).
- Detail-oriented with a high level of accuracy.
- Ability to work independently and collaboratively within a team environment.
- Strong negotiation and influencing skills.
- Commitment to ethical research practices and patient safety.