Position: In-house Clinical Research Associate (CRA)
Objectives
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
- Tracking and reporting serious adverse events to appropriate local/national authorities
- 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 experience in pharmaceutical/biotechnology setting as a CRA
- 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 with some international, may be required.
Send resume to jobs@biothera.com. No calls please.