1,189 Senior Cra jobs in India
Cra - Global Clinical Trials
Posted today
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- Identifying investigators, perform feasibility and assessing sites with regard to protocol and local requirements.
- Acting as the main line of communication between the sponsor and the investigators.
- Training of investigator and the clinical site staff on all trial requirements & procedures.
- Assisting trial team with site budget negotiation and execution of site contracts.
- Conducting site visits and preparing monitoring reports (e.g. selections, initiation, periodic, close-out).
- Verification of source documents,IP accountability, lab data review etc.
- Willingness to travel for 15-16 days of month to various locations inIndia.
- Assisting with and/or prepare all necessary documentation for IEC/IRB and regulatory submissions.
**Job Requirements**:
- Bachelor's or Master's degree in Lifesciences.
- 3-4 years of experience & good understanding of clinical research.
- Excellent communication skills.
- Ability to be autonomous and self-motivated.
- Fluent in English.
- Travel required.
Clinical Research Associate (CRA)
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Key responsibilities include initiating, monitoring, and closing out clinical trial sites. You will conduct routine monitoring visits (remote and on-site as needed), verifying the accuracy and completeness of data, and ensuring proper source document verification. You will also be responsible for reviewing regulatory documents, managing investigational product, and ensuring compliance with protocol requirements. The role involves close collaboration with investigators, study coordinators, and internal study teams to resolve any site-specific issues and ensure the timely recruitment and retention of participants. You will also be tasked with preparing site monitoring reports and communicating findings to the study team.
The ideal candidate will have a Bachelor's degree in a life science, nursing, pharmacy, or a related field. A minimum of 3-5 years of direct CRA experience is required. Strong knowledge of ICH-GCP guidelines, FDA regulations, and clinical trial processes is essential. Excellent organizational, communication, and interpersonal skills are necessary for building strong relationships with study sites. The ability to work independently and manage multiple priorities in a remote setting is crucial. Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems is expected. If you are passionate about advancing pharmaceutical research and contributing to significant breakthroughs from a remote location, we encourage you to apply.
Clinical Research Associate (CRA)
Posted today
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Job Description
Key responsibilities include identifying, evaluating, and initiating new clinical trial sites, as well as ongoing site management and close-out activities. You will conduct pre-study visits, site initiation visits, routine monitoring visits, and close-out visits, assessing protocol adherence, data integrity, and regulatory compliance. The CRA will serve as the primary liaison between the study site staff and the sponsor, providing training and support to site personnel. You will review essential documents, Case Report Forms (CRFs), and source data, ensuring they are accurate, complete, and timely. Troubleshooting site issues, implementing corrective actions, and tracking progress are critical aspects of the role.
We are looking for a highly organized individual with excellent attention to detail and strong analytical skills. Exceptional communication, interpersonal, and problem-solving abilities are essential for effective site interaction and collaboration. A Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline is required. A minimum of 3-5 years of experience as a CRA or in a similar clinical research role is necessary. Previous experience with various therapeutic areas is a plus. Knowledge of clinical trial management systems (CTMS) and electronic data capture (EDC) systems is highly desirable. Join our client and contribute to advancing life-saving medicines from their operations in Delhi .
- Monitor clinical trial sites.
- Ensure data accuracy and integrity.
- Verify subject eligibility and safety.
- Perform site initiation and close-out visits.
- Liaise between sites and the sponsor.
- Train site personnel on protocols.
- Review essential regulatory documents.
- Track study progress and identify issues.
- Implement corrective action plans.
- Adhere to GCP and regulatory guidelines.
Clinical Research Associate (CRA)
Posted 1 day ago
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Job Description
Key Responsibilities:
- Monitor clinical trial sites to ensure compliance with protocols and regulations.
- Verify the accuracy, completeness, and integrity of clinical data.
- Conduct site initiation, interim, and close-out visits.
- Train and support site staff on study-related procedures.
- Manage communication between sponsors, investigators, and study personnel.
- Ensure timely reporting of adverse events and protocol deviations.
- Review source documents and electronic data capture (EDC) systems.
- Prepare monitoring visit reports and follow-up actions.
- Bachelor's degree in a scientific or healthcare-related field (e.g., Nursing, Pharmacy, Biology).
- Minimum 4 years of experience as a Clinical Research Associate.
- Thorough knowledge of Good Clinical Practice (GCP) and ICH guidelines.
- Experience with clinical trial monitoring and site management.
- Proficiency in electronic data capture (EDC) systems.
- Excellent communication, interpersonal, and problem-solving skills.
- Ability to travel to study sites as required.
- Strong organizational skills and attention to detail.
Clinical Research Associate (CRA)
Posted 1 day ago
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Job Description
Clinical Research Associate (CRA)
Posted 1 day ago
Job Viewed
Job Description
Key Responsibilities:
- Conducting site initiation, interim monitoring, and close-out visits for clinical trials.
- Ensuring adherence to study protocols, FDA regulations, and ICH-GCP guidelines.
- Verifying accuracy and completeness of clinical data collected at study sites.
- Training and mentoring site staff on study procedures and data collection.
- Managing and troubleshooting site-specific issues to ensure smooth trial conduct.
- Preparing and presenting monitoring visit reports.
- Maintaining effective communication with investigators, site staff, and internal project teams.
- Ensuring the safety and rights of trial participants are protected.
- Managing study supplies and investigational product at clinical sites.
- Facilitating regulatory audits and ensuring site readiness.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 2 years of experience as a Clinical Research Associate or in a similar clinical research role.
- Thorough understanding of clinical trial processes, ICH-GCP, and relevant regulatory requirements.
- Excellent monitoring skills and attention to detail.
- Strong organizational and time management abilities.
- Effective communication and interpersonal skills.
- Ability to travel to clinical sites as required (approximately 60-70% travel).
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Problem-solving skills and the ability to work independently.
Clinical Research Associate (CRA)
Posted 1 day ago
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Clinical Research Associate (CRA)
Posted 2 days ago
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Key Responsibilities:
- Conduct site visits for monitoring clinical trials.
- Ensure compliance with protocols and regulatory guidelines.
- Verify data accuracy and completeness.
- Manage investigational product accountability.
- Train site staff on study procedures.
- Maintain trial master file documentation.
- Report on site performance and identify potential risks.
Clinical Research Associate (CRA)
Posted 2 days ago
Job Viewed
Job Description
Responsibilities:
- Conduct site initiation visits, routine monitoring visits, and close-out visits at clinical trial sites.
- Monitor study conduct to ensure compliance with protocol, Good Clinical Practice (GCP) guidelines, and regulatory requirements.
- Verify the accuracy, completeness, and validity of clinical trial data through source data verification (SDV).
- Ensure all investigational product accountability and manage its proper storage and dispensing.
- Oversee patient recruitment and enrollment processes at trial sites.
- Identify and report any adverse events (AEs) and serious adverse events (SAEs) according to established procedures.
- Train and support study site staff on protocol requirements and study procedures.
- Build and maintain strong relationships with investigators and site personnel.
- Prepare monitoring visit reports and ensure timely resolution of site-related issues.
- Manage trial site logistics, including essential documents and regulatory binders.
- Ensure data quality and integrity by performing regular data reviews.
- Communicate effectively with the study team, including project managers, medical monitors, and data management.
- Stay updated on therapeutic areas, relevant protocols, and regulatory guidelines.
Qualifications:
- Bachelor's degree in life sciences, nursing, pharmacy, or a related field. A Master's degree is a plus.
- Minimum of 3-5 years of experience as a Clinical Research Associate or in a similar role within the pharmaceutical or biotech industry.
- Thorough understanding of GCP, ICH guidelines, and relevant regulatory requirements (e.g., FDA, EMA).
- Experience with various therapeutic areas and clinical trial phases.
- Proficiency in Electronic Data Capture (EDC) systems and clinical trial management systems (CTMS).
- Strong monitoring and auditing skills.
- Excellent organizational, time management, and problem-solving abilities.
- Effective communication, interpersonal, and presentation skills.
- Ability to travel to study sites as required (frequency may vary).
- Proficiency in Microsoft Office Suite.
- Ability to work independently and manage a remote workload effectively.
Clinical Research Associate (CRA)
Posted 2 days ago
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