Note: The job is a remote job and is open to candidates in USA. Entrada Therapeutics is a clinical-stage biopharmaceutical company aiming to transform the lives of patients through innovative genetic medicines. The Senior Clinical Trial Associate will assist the clinical operations team in managing the day-to-day operations of clinical trials, ensuring compliance with established standards and protocols.
Responsibilities
- Support the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with ICH/GCP guidelines, from study start-up to close-out
- Provides accurate and up-to date clinical trial information within relevant tracking tools and provides regular updates of trial progression to the clinical trial team, including those related to protocol deviations, adverse events, and site personnel trainings
- Contribute to the development of trial related plans and manuals
- Ensures timely maintenance of the TMF, filing and reconciliation according to regulatory guidance and internal SOPs
- Participates and ensures appropriate documentation of clinical team meetings, including meeting minutes, agendas, and action items
- Manage vendor POs and trial payments (including budget reconciliation), including invoice review and approval
- Support the set-up and management of clinical trial supplies and biosample management where needed (drug product, ancillary and other)
- Assist in external training activities (suppliers, clinical sites etc.)
- Assist in the management of trial completion activities, including data review, database lock and trial closeout
Skills
- BA/BS degree with at least 2+ years of relevant experience in clinical operations working at a biotech or pharmaceutical company
- Strong understanding of clinical trial operations, including all phases from study start-up to close-out
- Ability to work independently and take initiative on projects under minimal supervision
- General working knowledge of drug development and ICH/GCP guidelines is required
- Excellent interpersonal, written, administrative, and computer skills
- Excellent verbal and written communication skills with a strong attention for detail
- Ability to travel approximately 5% of the time, as determined by the needs of the business
- Previous CRO or vendor management experience preferred
Company Overview
Company H1B Sponsorship