What are the responsibilities and job description for the Clinical Protocol Writer position at Insight Global?
Must-haves
- Advanced clinical health sciences degree (i.e., PharmD, MSN, NP, MD) or PhD
- Prior experience writing clinical protocols
- Possess excellent written and oral communication skills
- Have a strong record of experience in study design and protocol development (clinical research).
- Have a working knowledge of federal and local regulations of biomedical trials and biostatistics.
- The candidate must enjoy working collaboratively with multidisciplinary groups of colleagues.
Plusses
- Experience and expertise in oncology research is highly desirable.
- Experience working in an academic environment beyond PhD/post doc years.
Day-to-Day
60%: This position will be responsible for aiding investigators in the strategic planning behind protocol design. This position will aid investigators in the translation of bench research to the clinic by writing, editing and providing consultation for clinical protocol documents for investigator-initiated trials (IITs). Consultation includes emphasis on study design in active collaboration with the Principle Investigator, Biostatistician, and Funding Sources (outside pharmaceutical companies or grant agencies). This position will be responsible evaluating the protocol design and providing recommendations for the improvement of design strategies that may streamline the logistics of operationalizing the protocol and the reducing protocol budgets. The initial writing process will also include leading of protocol review meetings during which the study team meets to discuss the content of the draft protocol document. Responsibilities may also include, but are not limited to: supporting the writing of protocol/clinical research documents and/or the ongoing management of pre-written protocol/clinical research documents through the clinical trial development/implementation process, budget development and writing of informed consent forms. The position will also support the coordination of study logistics/approvals as well as the verification that the protocol content meets institutional, industry and federal standards.
20%: This position will support the ongoing development of clinical trial protocols by responding to requests for amendments and administrative letters to the existing clinical protocol. This individual will collaborate with Principal Investigators and study teams in drafting these amendments and administrative letters to the clinical trial in a way that minimizing the disruption to the operations of the trial.
10%: This position will work with pharmaceutical medical science liaisons to determine potential funding opportunities for new clinical trials. This individual wil! l support proactive review/screening of new IIT opportunities via liaising with pharmaceutical companies through key oncology meetings and symposia. This position will also support writing and submission of letters of intent (LOIs) to pharmaceutical companies in order to secure funding for new investigator initiated trial opportunities.
10%: This position will support education of Cancer Center fellow, new facility (including MDs and PharmDs) and clinical trial office staff in protocol development. This will include training of junior level protocol writers and quality assurance of their work. This will also include protocol training to the clinical trial staff on the major changes in the protocol after amendment finalization.
Job Type: Full-time
Pay: $40.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Vision insurance
Schedule:
- 8 hour shift
Education:
- High school or equivalent (Preferred)
Work Location: One location