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
This role is fully remote; qualified candidates may sit anywhere in the United States. 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!
