ACM is hiring for the position of Clinical Trials Administrator (CTA) in the Study Support department in Mumbai, India. The role involves clinical trial coordination, study documentation, Laboratory Information Management System (LIMS) setup, quality control, regulatory compliance, and clinical trial supply logistics.
Candidates with a master’s degree in Biochemistry, Microbiology, or Chemistry and 1–2 years of relevant experience in a central laboratory or Contract Research Organisation (CRO) are preferred.
Job Details
| Particulars | Details |
|---|---|
| Company | ACM |
| Job Title | Clinical Trials Administrator |
| Department | Study Support |
| Location | Mumbai, Maharashtra, India |
| Job Type | Full-time |
| Working Hours | 40 hours per week |
| Work Schedule | Monday to Friday |
| Experience | 1–2 years preferred |
| Qualification | Master’s degree in Biochemistry, Microbiology, or Chemistry preferred |
| Job Requisition ID | REQ_243979 |
| Application Mode | Online |
Position: Clinical Trials Administrator
The Clinical Trials Administrator supports clinical studies from setup through closeout. The position requires coordination with sponsors, Contract Research Organisations (CROs), investigator sites, laboratory teams, and logistics vendors to maintain documentation accuracy, data quality, and timely study deliverables.
Roles and Responsibilities
Selected candidates will be responsible for the following activities:
1. Clinical Trial Coordination
- Review clinical trial protocols and support protocol setup.
- Prepare Protocol Test Summaries, Global Laboratory Specification Documents, Investigator Laboratory Manuals, and protocol-specific operating procedures.
- Coordinate with sponsors, CROs, alliance laboratories, clients, and investigator sites.
- Participate in study calls, prepare meeting minutes, track action items, and monitor study metrics.
- Resolve queries, follow up on missing or unlabelled samples, and maintain study records.
2. Project Documentation and Quality Control
- Maintain study binders and support document filing, review, and archiving.
- Conduct secondary quality control reviews of study binders.
- Support data cleaning and quality control of clinical study documents during the data lock process.
- Submit reviewed project documents for approval and arrange archiving in accordance with ICH-GCP guidelines.
3. LIMS Project Setup and Validation
- Coordinate project setup in Laboratory Information Management Systems (LIMS).
- Configure protocols, test and visit schedules, requisitions, and site lists.
- Support Kit Order Manager (KOM) setup and inventory notifications.
- Conduct quality control of protocol setups, requisitions, and kit configurations across LIMS environments.
- Prepare validation plans and test cases, and support system validation.
4. Clinical Trial Supply Logistics
- Monitor inventory of phlebotomy kit components and coordinate with internal logistics teams and vendors.
- Liaise with logistics agencies for the distribution of phlebotomy kits to investigator sites.
- Prepare logistics documentation required for transportation.
- Coordinate with laboratory, specimen processing, project management, and data management teams to support timely specimen analysis and laboratory reporting.
5. Compliance and Operational Support
- Support clinical trial quality audits and inspections.
- Apply working knowledge of GCP, GDP, ICH guidelines, and relevant regulatory requirements for central laboratory operations.
- Follow company SOPs, escalation procedures, change control, and communication requirements.
- Identify opportunities to improve productivity, service quality, cost efficiency, and operational processes.
Eligibility and Qualifications
Candidates interested in the Clinical Trials Administrator job at ACM should meet the following preferred qualifications:
- Master’s degree in Biochemistry, Microbiology, or Chemistry.
- 1–2 years of experience in a similar role within a central laboratory or Contract Research Organisation (CRO).
- Customer service experience.
- Computer proficiency, with familiarity with relational databases and reporting tools preferred.
- Ability to manage multiple tasks and prioritize workloads effectively.
Required Skills
- Clinical trial coordination and study administration.
- Clinical study documentation and quality control.
- LIMS setup and validation.
- Clinical trial supply and logistics coordination.
- Knowledge of GCP, GDP, and ICH guidelines.
- Written and verbal communication.
- Client and stakeholder coordination.
- Critical thinking and problem-solving.
- Multitasking and workload prioritization.
