Job Title: Clinical Trials Administrator
Department: Study Support

Location: Mumbai, India

Hours Per Week: 40 hours
Schedule: Days, Monday – Friday

SUMMARY 
The Clinical Trials Administrator [CTA] is responsible for coordinating clinical trial activities from study set-up through closeout, ensuring accurate documentation, data quality, regulatory compliance, and timely project deliverables. Collaborates with clients, investigator sites, laboratory teams, and vendors to support study operations, LIMS set-up, quality control, and clinical trial supply logistics while maintaining service standards and a positive client experience.

RESPONSIBILITIES 

Project Management

• Review Clinical Trial Protocols and assist with protocol set-up functions as required.
  Develops 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 customises reports to monitor study metrics / trends (i.e. Action Items, supplies shipped, cancelled tests, etc.)
• Interface with client, sponsor, 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• Assist PM with binder management / file documents in binder (including binders that have been archived)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 submits the binder to PM for review
• Site list management
• Adding, removing, and modifying sites / contacts into LabStar WIN
• Site support / incoming calls / Alert Calls and emails
• Ensure that the data cleaning & quality control of all the 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, and following SOP’s including escalation, change control, & communication
  

Project Set-up

• 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
• Validation & QC
• 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

Logistics

• Manage inventory of supplies of kit components for phlebotomy kit assembly by liaisoning internally with logistics and with vendors who supply kit components
• Liaison and interface with appointed logistic agency for supply of phlebotomy kits to investigator sites
• Draft out logistic documents required to be submitted to logistic agency for transport
• Interfaces 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
• Participates and documents Quality Audits and inspections of Clinical Trials as prescribed by departmental policies and regulatory agencies
• Performs 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
•  Ensure that the Team is kept motivated and aligned to the business objective of the organization understands and follows company policies and procedures while always maintaining confidentiality, both inside and outside of the work place
• Maintain financial performance of company by executing on job duties as specified and by proactively and continuously bringing to management’s attention ideas 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 on-line training in addition to industry functions, certifications, publications, and other available training resources
• Perform other duties as assigned

This job description is not intended to be exhaustive. The employee may be required to undertake any other duties that are reasonably required and are commensurate with the skills, experience and level of responsibility of the role. 

PREFERRED QUALIFICATIONS

• Master’s degree in Bio-chemistry, Microbiology or Chemistry.
• 1 to 2 year’s experience in a similar capacity in a Central Laboratory or Contract Research Organisation.
• Excellent verbal and written communication skills required.
• Computer proficiency required; familiarity with relational databases and reporting tool strongly preferred.
• Ability to multi-task and prioritize workload required.
• Customer Service experience required.
• Critical thinking and ability to problem-solve.

PHYSICAL REQUIREMENTS:

Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.