In-House Senior Clinical Research Associate
An innovative, Oncology-focused, start-up sized Boston biotech has an urgent need for an experienced In-House Senior Clinical Research Associate!
My client has growing pipeline including studies in phases 1-4 at present. In order to support their bustling pipeline, my client is looking to add talented Clin Ops professionals to its team!
Responsibilities for the In-House Senior Clinical Research Associate include but are not limited to:
- Set up vendors, sites
- Review Study Plans, including making comments and edits
- Assist in the ICF development process, including reviewing and editing documents for final approvals
- Undertake process of getting ICF documents reviewed internally
- Tracking of study activities, especially at the site level
- Support cross-functional study teams by ensuring timely and effective project tracking and administrative support of clinical research studies
- Support clinical trial managers and directors of clinical operations where 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 Trial Manager to determine escalation
Qualifications include:
- 3+ years IN-HOUSE Senior Clinical Research Associate experience MINIMUM
- 5+ years industry sponsor clinical research experience
- Extensive study start-up experience
- Oncology experience is highly preferred
- Phase II trial 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
- Organization skills, with a detail-oriented nature
- Experience interacting internal and external study stakeholders