A small but thriving Bay Area Biotech is looking to add a talented Sr. Clinical Trial Associate to its team! The client focuses on combating Rare Diseases and improving the lives of those with these diseases.
This Biotech boasts a pipeline from Preclinical to Phase III, to support the increase in clinical trials are looking to add a talented Senior Clinical Trial Associate to their team.
Responsibilities will include but are not limited to:
- Management of all clinical documents
- TMF oversight and reconciliation
- Management and maintenance of TMF
- Support cross-functional study teams by ensuring timely and effective project tracking and administrative support of clinical research studies
- Support clinical study managers and directors of clinical operations where needed
- Coordinate team and investigator meeting, take meeting minutes as needed
- Updating milestones on clinicaltrials.gov
- Coordinate the ordering and delivery of needed supplies such as lab supplies, drug supplies, etc. as needed
- Contribute to development of SOPs
- Participation in regular internal quality auditing of clinical study documents
Qualifications include:
- BA or BS in a life sciences field or healthcare, or a BSN
- 3+ years clinical research experience
- Knowledge of ICH GCP regulations, SOPS and internal tracking systems
- Effective interpersonal and communication skills
- Flexibility and adaptability within a highly dynamic clinical environment
- Ability to work independently as well as part of a team
- Ability to build and maintain successful professional relationships with vendors, other staff and investigators
- Experience with TMF maintenance and management
- Organization skills, with a detail-oriented nature
- This role is hybrid, with 2-3 days a week in office in the BAY AREA
