The Company
My client is a global biopharmaceutical company based in Massachusetts. Their research focuses on rare disease. They are dedicated in developing market therapies that impact patient lives. They have an opportunity for a Clinical Trial Assistant to join their team!
Role Summary:
The Clinical Trial Associate will assist in the delivery of Clinical Operations objectives by providing administrative support to the clinical team with the responsibility to manage multiple clinical trials (all phases), and assure compliance with SOPs, FDA regulations, GCP and ICH guidelines.
Responsibilities
- Responsible for the collection of essential documents and maintenance of both paper and electronic Trial Master File.
- Performs periodic Trial Master File quality control check through the course of study as defined by the study team, per ICH GCP requirements.
- Works with cross-functional team to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, project plans, ICH/GCP guidelines and government regulations.
- Responsible for the QC activities of the Sponsor and CRO supported TMF at intervals specified in project plan or applicable SOPs or prior to the transition of the TMF to the company at end of study. Partner with Quality Assurance team to perform audits/inspections for CRO/vendors in preparation of regulatory body inspections and potential vendor contracts.
- Follows up with CROs, functional area representatives on outstanding documentation in accordance with TMF metrics.
- Provide clerical support and administrative functions for the Clinical Operations team with heavier focus on study start-up activities.
- Participates in the review of clinical trial agreements, work orders and other site/vendor agreements. Will assist in the review and processing of invoices related to such study agreements.
- Assists with the tracking and documenting of site and sponsor training (Study specific, drug and program level).
- Provides support and assist with all phases of clinical study activities (feasibility, start-up, maintenance, and close-out).
- Participates in study team and vendor meetings. Schedule meetings and draft meeting minutes/distribute final minutes, as needed. At CST’s provides update on health of study TMF.
- Reviews CRO/Vendor SOPs for applicability and gap analysis to support the company’s clinical trials.
- Coordinates activities related to Regulatory Inspection - (Prep, retrieval of documents and other “back-room” activities and support).
- Support Vendor audits, when needed.
- Participates in the creation and distribution of study materials, including essential documents, presentations, and reports.
- Ensures timely payment execution for the assigned sites/study(s) according to the clinical study agreements and as per local requirements.
- Process payments to vendors via Procurement system.
- Tracks Protocol Deviations.
Qualifications
- Bachelor's degree required, science background preferred
- Minimum of 1-year experience in clinical research
- Basic knowledge of GCP and ICH guidelines in clinical trials
- Experience with TMF both paper and electronic (eTMF) preferred.
- Basic understanding of the DIA TMF Reference Model.
Travel Requirements:
- Up to 10% travel, both domestic and/or international
Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything