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Clinical Research Associate

2 weeks ago

Thailand ProRelix Services LLP Full time

**Responsibilities**:

- Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol.
- Communicate with medical site staff, including coordinators, clinical research physicians, and their teams.
- Verify Investigator qualifications, training, and resources, ensuring facilities, laboratories, equipment, and staff are adequate.
- Verify medical records and research source documentation against case report form data, ensuring adherence to good documentation practices and reporting any errors or deviations appropriately.
- Assist in writing and finalizing essential documents such as protocols, Investigator Brochures, Patient Information Sheets, and Case Report Forms.
- Assess completeness, accuracy, and maintenance of regulatory documents both in-house (CSF) and on-site (ISF).
- Ensure appropriate storage and accountability of Investigational Medicinal Product (IMP) per protocol specifications.
- Review adverse events, serious adverse events, concomitant medications, and corresponding illnesses to ensure accurate data reporting.
- Proactively identify project issues, propose resolutions, and escalate when necessary.
- Assess patient recruitment and retention success at clinical research sites and provide suggestions for improvement.
- Complete monitoring reports and follow-up letters, summarizing significant findings, deviations, deficiencies, and recommended actions for compliance.
- Resolve any CRO-related queries from sponsors.
- Build and maintain site databases.
- Manage communication and relations with vendors.

**Required Education**:

- Life Science Graduate with UG/PG Diploma in Clinical Research, or B Pharm/ M Pharm, or any medical graduation

**Required Experience**:

- 3-4 years in clinical trial operations

**Skill sets required**:

- Expert knowledge of ICH-GCP, Schedule Y, New Drugs and Cosmetics Rules, and other applicable regulatory requirements, with the ability to train others on relevant guidelines.
- Familiarity with clinical trial phases and essential documents.

**Other Requirements**:

- 40%-60% travel required.
- Proficiency in handling technical assets such as laptops, MS Office, Outlook, IWRS, RMP, eCRF, etc.

**Job Type**: Contract