Clinical Research Associate / Medical Affairs

Employer
HiberCell
Location
New York, NY, United States
Posted
Oct 24, 2020
Ref
2092572156
Hotbed
NextGen Bio
Required Education
Bachelors Degree
Position Type
Full time
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.

Responsibilities:
  • 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.

Qualifications:
  • 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