Job Description

SUMMARYAs part of the ACM Clinical Trails Study Support team this role supports both the Project Team and Clinical Trials Investigator sites from study set up through to study close out. Acts 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.STATUS: Full TimeLOCATION: On-siteDEPARTMENT: Study SupportSCHEDULE: Monday - FridayATTRIBUTES

• Master's degree in Bio-chemistry, Microbiology or Chemistry preferred.
• 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.

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 and summarize actions. 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 unlabeled 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 Assist PM with binder management / file documents in binder (including binders that have been archived).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 checked 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. Complete and submit patient report, custom flagging, and requisition request forms Requisitions. Kit Order Manager (KOM) setup (including inventory notification to logistics) and QC and validation. QC of Protocol set-up summaries in each LIMS environment. QC of requisitions set-up in each environment. Validate the LIMS Protocol Set-up
• Logistics and Administration. Manage inventory of supplies of kit components for phlebotomy kit assembly by liaising 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

Job Type: Full-timePay: Up to ?460,000.00 per yearSchedule:

• Day shift

Ability to commute/relocate:

• Andheri, Mumbai - 400 093, Maharashtra: Reliably commute or planning to relocate before starting work (Required)

Experience:

• total work: 1 year (Preferred)