2,532 Cra jobs in India
Clinical Research Associate (CRA)
Posted today
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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 3 days ago
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Job Description
Clinical Research Associate (CRA)
Posted 4 days ago
Job Viewed
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 4 days ago
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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 6 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.
Clinical Research Associate (CRA)
Posted 6 days ago
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Job Description
Clinical Research Associate (CRA)
Posted 6 days ago
Job Viewed
Job Description
Responsibilities:
- Plan, manage, and conduct on-site and remote monitoring visits for clinical trials.
- Ensure study conduct in accordance with protocol, SOPs, GCP, and regulatory requirements.
- Verify accuracy, completeness, and quality of clinical data.
- Manage site relationships, providing guidance and support to investigators and study staff.
- Initiate, monitor, and close-out clinical trial sites.
- Review and track regulatory documents and essential study files.
- Oversee drug accountability and study supplies.
- Report site progress, identify issues, and implement corrective actions.
- Ensure subject safety and adherence to ethical principles.
- Prepare monitoring reports and contribute to study documentation.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 3 years of experience as a Clinical Research Associate (CRA).
- Thorough knowledge of GCP, ICH guidelines, and regulatory requirements.
- Experience with various phases of clinical trials.
- Strong monitoring skills and ability to identify and resolve site issues.
- Excellent written and verbal communication skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to study sites as required.
- Strong organizational and time-management skills.
- Detail-oriented with a commitment to data integrity and patient safety.
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Clinical Research Associate (CRA)
Posted 7 days ago
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Job Description
Key Responsibilities:
- Perform site selection, initiation, monitoring, and close-out visits in accordance with clinical trial protocols and regulatory requirements.
- Ensure the quality and integrity of clinical trial data through source data verification and query resolution.
- Verify that the trial is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and applicable regulatory requirements.
- Monitor patient safety and report adverse events and serious adverse events according to established procedures.
- Train and support site staff on trial procedures, regulatory requirements, and protocol compliance.
- Maintain accurate and complete trial documentation, including monitoring reports and essential documents.
- Collaborate effectively with investigators, site personnel, study sponsors, and other stakeholders.
- Manage study timelines and ensure timely completion of trial milestones.
- Troubleshoot and resolve site-specific issues that may arise during the trial.
- Prepare for and participate in regulatory authority inspections and audits.
- Contribute to the continuous improvement of clinical research processes and best practices.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
- Minimum of 3 years of experience as a Clinical Research Associate or equivalent.
- In-depth knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements (e.g., ICH).
- Proven experience in clinical trial monitoring and site management.
- Strong understanding of medical terminology and clinical trial procedures.
- Excellent communication, interpersonal, and organizational skills.
- Ability to travel to clinical trial sites as required.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Detail-oriented with a strong commitment to accuracy and quality.
- Ability to work independently and manage multiple priorities effectively.
Clinical Research Associate (CRA)
Posted 7 days ago
Job Viewed
Job Description
Clinical Research Associate (CRA)
Posted 7 days ago
Job Viewed
Job Description
- Conduct site initiation, monitoring, and close-out visits in accordance with study protocols and GCP.
- Verify the accuracy, completeness, and integrity of clinical trial data through source document verification.
- Ensure compliance with study protocols, investigational plans, and applicable regulatory requirements (e.g., FDA, EMA, DCGI).
- Train and support site staff on study procedures, data collection, and regulatory compliance.
- Manage communication between study sites, the sponsor, and other stakeholders.
- Identify and resolve site-level issues and escalate critical matters as needed.
- Ensure timely submission of study-related documents and reports.
- Maintain accurate and up-to-date study documentation and trial master files.
- Participate in protocol review and development as required.
- Contribute to the overall quality and success of the clinical trial program.
- 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.
- In-depth knowledge of GCP, ICH guidelines, and local 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 multitasking skills.
- Exceptional written and verbal communication skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently and collaboratively in a hybrid work environment.
- Attention to detail and a commitment to data accuracy and patient safety.