Clinical Study Associate
A well-known global pharmaceutical company based in the New Jersey area is looking to add a talented Clinical Research professional to its team! The client focuses on oncology and rare disease therapeutics.
My client has a very diverse pipeline including studies in phases 1-4 at present. Their therapeutic areas of focus include oncology and rare diseases. In order to support their bustling pipeline, my client is looking to add talented Clin Ops professionals to its team!
Responsibilities for the Clinical Study Associate 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
- Keeping all study documents audit ready
- Serve as point of contact with CROs and other third-party vendors
- Review CRO-generated reports, elevate any deviation or protocol issues to Study Manager to determine escalation
Qualifications include:
- BA or BS in a life sciences field preferably
- 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
- Experience interacting internal and external study stakeholders
*This role is open to candidates local to the New Jersey area.
There is an URGENT need for these opportunities to be filled, and interviews are being conducted as soon as this week. Don't hesitate to apply TODAY!
