Clinical Research Associate
Jobot Blacksburg, VA
- Expired: over a month ago. Applications are no longer accepted.
This Jobot Job is hosted by: Emmet Nitto
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $65,000 - $90,000 per year
A bit about us:
Based in Blacksburg VA, we are a biotech startup developing an oral first-in-class therapeutics designed to target autoimmune diseases. We are looking for a Clinical Research Associate to join our growing team!
Why join us?
- Competitive Salary!
- Extremely Competitive Benefits Package
- Adaptable/Flexible Schedule!
- Conducts site visits to determine protocol and regulatory compliance, and prepares required documentation. - Requires travel to be physically on location to conduct site visit.
- Responsible for multiple projects and must work both independently and in a team environment.
- Participates in the study development and start up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings.
- Works with management on monitoring strategy.
- Track items related to CDAs, budget and contract completion status.
- Assurance of regulatory compliance of investigational sites with company SOPs, EMA/FDA and ICH guidelines.
- Perform clinical data review of data listings and summary tables, including query generation.
- Creating and writing trial protocols, and presenting these to the steering committee.
Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial.
- Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
- Liaise with the ethics committee regarding the rights, safety, and well-being of trial subjects.
- Ordering, tracking, and managing IP and trial materials.
- Overseeing and documenting IP dispensing inventory, and reconciliation.
- Protecting subjects’ confidentiality, updating their information, and verifying IP have been dispensed and administered according to protocol.
- Conducting regular site visits, coordinating project meetings, and writing visit reports.
- Implementing action plans for sites not meeting expectations.
- Liaising with regulatory authorities.
- Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
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