Clinical Research Associate

Employer
HiberCell
Location
New York, NY, United States
Posted
Oct 01, 2020
Ref
1373791806
Hotbed
NextGen Bio
Required Education
Bachelors Degree
Position Type
Full time
The in-house CRA will perform clinical research duties to promote the successful clinical development of Biothera's proprietary compound. As assigned, responsibilities may include, but are not limited to:
  • Tracking subject recruitment and progression as well as selected study data points
  • Assisting with preparation/collection, review, and tracking of regulatory documents for US and global studies
  • Creating and/or reviewing informed consents, coordinators' manual, pharmacy manual, source documents, and other documentation required for the conduct of a clinical trial
  • Assisting with the creation and maintenance of the trial master file
  • Reviewing clinical data in-house and communicating with study site personnel to resolve data queries
  • Ordering clinical supplies for assigned studies and maintaining accurate records of drug accountability/compliance across the study(s)
  • Participating in the development of protocols and case report forms
  • Conducting/participating in co-monitoring and/or auditing visits
  • Liaising with vendors and investigative site staff

Candidate Qualifications:

Preference will be given to candidates with the following qualifications:
  • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
  • Minimum two years of relevant experience in pharmaceutical/biotechnology setting and oncology research experience
  • Thorough knowledge of ICH Guidelines and GCP/CFR
  • Understanding of serious adverse event reporting process
  • Ability to work independently
  • Excellent computer skills with good working knowledge of a range of computer packages including Word and Excel
  • Excellent verbal and written communication skills and detail oriented

Travel Requirements:
  • Minimal travel may be required.