Clinical Research Associate / Medical Affairs
This position will plan, coordinate and execute the activities surrounding external collaborations, investigator-initiated studies, clinical and scientific board and KOL activities, scientific/medical publications, and other clinical research/ development associate activities as assigned.
- Develop a clear and measurable project management plans in conjunction with management to establish scientific and clinical advisory boards including, but not limited to:
- Overarching scientific and advisory boards
- Indication-specific boards
- Clinical trial steering committees (protocol-specific)
- Data review committees (protocol-specific/ blinded and unblinded)
- With management draft and finalize required support documents including, but not limited to: SOPs, charters, agreements, etc.
- At direction of management, initiate KOL meetings, CDAs and consulting agreements
- Work with management to establish publication goals and establish tracking system to track and guide conference abstract and poster submission dates; manuscript opportunities and timelines; obtain and maintain author approvals, disclosures, and implement SOP with review/ approval process.
- Act as primary liaison for publications with individual IIS and pharma collaborators.
- As Clinical Research Associate support trial set-up and conduct through essential document review, monitoring report review, site and patient enrollment.
- Advanced degree or BS/BA degree with 3-5 years of relevant experience in Medical Affairs/ oncology research..
- A minimum of 3 years relevant project management experience in the pharmaceutical.
- Working knowledge of scientific and medical publication regulations
- Demonstrated ability to manage multiple projects, meet deadlines, and utilize resources effectively
- Proficiency in Microsoft Office, graphic production experience a plus