We are looking for a motivated and detail-oriented Clinical Research Associate (CRA) - I to join our Clinical Research Operations team. The CRA will be responsible for monitoring clinical trial sites to ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements. This role involves close collaboration with site staff, project managers, and cross-functional teams to support the successful execution of clinical studies.
Key Responsibilities:
Perform site monitoring visits (pre-study, initiation, routine, and close-out) in accordance with the monitoring plan.
Assist in site selection and feasibility assessments.
Ensure trial sites adhere to the study protocol, SOPs, and applicable regulatory guidelines. Verify source documents and ensure accurate data collection and reporting.
Maintain regular communication with site staff to ensure smooth trial conduct and resolve issues proactively.
Document and report findings in visit reports and follow-up letters.
Support site start-up activities including document collection and regulatory submissions.
Track subject recruitment and data entry progress.
Coordinate with clinical project teams and contribute to team meetings.
Maintain study documentation and Trial Master File (TMF) compliance.
Willingness to travel for site visits and monitoring activities as required by the study.
Ensure timely identification, documentation, and escalation of protocol deviations, safety concerns, or compliance issues.
Contribute to audit readiness by ensuring all monitoring and site activities are well documented and compliant.
Provide input to improve study tools, processes, or monitoring practices based on site feedback and field experience.
Support timely resolution of site queries and follow-up on pending actions from monitoring visits.
Maintain continuous awareness of project timelines and deliverables, and take responsibility for meeting assigned milestones.
Skills :
Excellent communication and interpersonal skills.
Strong organizational and time management abilities.
Proficient in MS Office tools (Word, Excel, Outlook, PowerPoint).
Attention to detail and ability to work independently in a dynamic environment.
Adaptability to work in a small team and contribute to the setup of processes and systems.
Education:
Bachelor's or Master's degree in Life Sciences, Pharmacy, Nursing, or related healthcare field.
Certification in Clinical Research is preferred.
Working knowledge of GCP, ICH guidelines, and basic regulatory environment.
Experience:
Minimum 1 years of experience in clinical research, preferably in roles supporting trial operations or site management.
Hands-on involvement in study coordination, site communications, or regulatory documentation.
Job location:
ProRelix Services LLP, Pune
Work mode :
Office based
About company:
ProRelix Research (ProRelix Services LLP) is a global clinical research organization with presence in India and USA. We are a full service clinical trial solution provider with high reputation in industry. If you are passionate and possess enthusiasm to develop and embark on a fulfilling career in clinical research industry, we encourage you to apply. Join us in out of box thinking environment where your skills and creativity will be admired for continuous personal growth.
Company website:
www.prorelixresearch.com
To apply:
career@prorelixresearch.com
Job Type: Full-time
Schedule:
Day shift
Monday to Friday
Work Location: In person
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