Clinical Trial Associate
Website Insmed Incorporated
Company : Insmed Incorporated
Country: United States
Location : Bridgewater, New Jersey
Post: Thu, 09 Sep 2021 12:39:50 GMT
Expires: Thu, 07 Oct 2021 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
Insmed is a growing global biopharmaceutical company powered by our purpose to deliver life-altering therapies to small patient populations experiencing big health problems. Our most valuable resource is our employees, and a patients-first mentality guides everything we do. Today, we are building a world-class team of talented individuals who are willing to challenge the status quo, solve problems, and work collaboratively and with a sense of urgency.
Come join us if you are ready to roll up your sleeves and be recognized for your efforts while working alongside team members who share your passion for serving patients and their families.
About the Role:
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.
Additional representative responsibilities will include, but not necessarily be limited to, the following:
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 Insmed 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 Insmed 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.
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.
Up to 10% travel, both domestic and/or international
This role is to be filled outside Colorado.
Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Please note that we review every submission and we will keep all submissions on file for six months. Insmed is an Equal Opportunity Employer.
To apply for this job please visit www.resume-library.com.