ACM Global Laboratories Job, Apply For Clinical Trials Administrator Position
Clinical Trials Administrator – India
Locations: ACM – India
Time Type: Full time
Posted On: Posted Today
Job Requisition ID: REQ_211050
Job Title: Clinical Trials Administrator
Department: Study Management
Location: Mumbai, India
Hours Per Week: 40
Schedule: Days; Monday – Friday
SUMMARY
As a member of our Clinical Trials Study Management team, the Clinical Trials Administrator supports the team from study commencement through study closeout. Act as a member of the Project Team to support all ongoing studies with tasks as needed, as defined by the Project Team or ACM client.
RESPONSIBILITIES
- Review Clinical Trial Protocols and assist with protocol set-up functions as required.
- Develop the Protocol Test Summary (PTS), Global Laboratory Specification Document (GLSD), Investigator Laboratory Manual, and protocol-specific operating procedures.
- Support day-to-day project-related activities once the study is live.
- Coordination with Sponsor, CRO & Alliance laboratory for each project.
- Participate in study conference calls with clients:
- Take minutes.
- Summarize actions from the meeting.
- Study metrics/trend monitoring:
- Generate and customize reports to monitor study metrics/trends (i.e., action items, supplies shipped, canceled tests, etc.).
- Interface with client, sponsor, and CRO:
- Query resolution.
- DIF follow-up with client/site contacts.
- Resolving unlabelled samples.
- Add history and close action items based on responses from sites/clients.
- Study binder management:
- Assist PM with binder management/file documents in binder (including binders that have been archived).
- Perform secondary binder QC review.
- Notify PM when binder has been finalized and submit the binder to PM for review.
- Site list management:
- Add, remove, and modify sites/contacts into LabStar WIN.
- Provide site support/incoming calls/alert calls and emails.
- Ensure that the data cleaning and quality control of all clinical study documents and records is done during the data lock process.
- Submit the QC’d documents/project files for review and seek approval from the PM.
- Upon receipt of the approval from the PM, forward all project-related documents for archival according to the ICH-GCP Guidelines.
- Maintain a positive study experience by engaging with clients, vendors, co-workers, and management with a positive attitude and by solving issues/requests in a timely manner per service and metric guidelines, following SOPs including escalation, change control, and communication.
Coordinates internally to set up assigned projects in LIMS:
- Protocol Set-up.
- Test & Visit Schedule.
- Complete and submit patient report, custom flagging, and requisition request forms requisitions.
- Kit Order Manager (KOM) setup (including inventory notification to logistics).
- Site list management:
- Adding sites/contacts into LabStar WIN.
- Providing LabStar Web Access – initial and updates.
- QC of protocol set-up summaries in each LIMS environment.
- QC of requisitions set-up in each environment.
- QC of kits set-up in KOM in each environment.
- Validate the LIMS protocol set-up:
- Validation plan drafting.
- Test cases & QC of test cases.
Additional Responsibilities:
- Manage inventory of supplies of kit components for phlebotomy kit assembly by liaising internally with logistics and vendors who supply kit components.
- Liaison and interface with appointed logistic agency for the supply of phlebotomy kits to investigator sites.
- Draft logistic documents required to be submitted to the logistic agency for transport.
- Interface with regional/reference/affiliate laboratory’s CT Specimen Processing, Project, and Data Management departments to ensure prompt turnaround of all specimen analysis, lab reports, as well as pending lab reports.
- Participate in and document quality audits and inspections of clinical trials as prescribed by departmental policies and regulatory agencies.
- Perform duties with a general working knowledge of regional regulatory bodies, GCP, GDP, ICH, and other pertinent regulations, as pertains to central laboratory functions.
- Actively assist the department director/head and reporting manager in the smooth functioning of the office.
- Understand and follow company policies and procedures while always maintaining confidentiality, both inside and outside of the workplace.
- Maintain the financial performance of the company by executing job duties as specified and proactively and continuously bringing ideas to management’s attention to improve productivity, service, quality, cost savings, process improvements, policies & procedures, and utilization of company resources.
- Improve job knowledge by in-house, outside work, self-study, and online training in addition to industry functions, certifications, publications, and other available training resources.
- Perform other duties as assigned.
REQUIRED QUALIFICATIONS
- Master’s degree in Biochemistry, Microbiology, or Chemistry.
- 1 to 2 years of experience in a similar capacity in a Central Laboratory or Contract Research Organization.
PREFERRED QUALIFICATIONS
- Excellent verbal and written communication skills.
- Computer proficiency required; familiarity with relational databases and reporting tools strongly preferred.
- Ability to multitask and prioritize workload.
- Customer service experience.
- Critical thinking and problem-solving skills.
Keywords: Clinical Trials Administrator, ACM Global Laboratories, Study Management, Mumbai, India, Bio-chemistry, Microbiology, Chemistry. ACM Global Laboratories Job, Apply For Clinical Trials Administrator Position. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebo
