The Clinical Research Associate (CRA) candidate will possess the skills needed to coordinate all aspects of the clinical monitoring process in accordance with GCPs and global SOPs and study protocols. The ideal candidate will have strong work ethics and interested in building a career in biotech/biopharma. A successful candidate will be a motivated, self-starter with proven ability to follow through. The CRA will work closely with the Executive Vice President of Operations and Regulatory Affairs as well as additional clinical and regulatory team members to meet goals and deadlines. A wide degree of creativity and latitude is expected. Some travel will be required for this role. Must have excellent oral and written communication skills.
The candidate will be completely aligned with the four fundamental pillars of Landos’ entrepreneurial and efficient corporate culture: 1) Be bold and decisive, 2) Never give up, 3) Be solution-oriented, and 4) Do the impossible.
- 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.
- Other tasks and responsibilities as needed.
- Maintains the strictest confidentiality of all activities.
- Team player, engendering credibility and confidence within and outside the company.
- Faithfully performs any other tasks requested by the Chairman, President & CEO.
- Act in accordance with Landos’ policies and in alignment with the corporate culture.