Care Access is looking to solve the problem of limited participation in clinical trials by physicians and patients, which currently stands at 3%. By removing this bottleneck, Care Access aims to accelerate the approval and delivery of critical and life-saving therapies.
Requirements
- Ability to understand and follow institutional SOPs.
- Excellent working knowledge of medical and research terminology
- Excellent working knowledge of federal regulations, good clinical practices (GCP)
- Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.
- Record data legibly and enter in real time on paper or e-source documents
- Accurately record study medication inventory, medication dispensation, and patient compliance.
- Recent phlebotomy experience required
Responsibilities
- Utilize Good Clinical Practices (GCPs) in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.
- Review and assess protocol (including amendments) for clarity, logistical feasibility
- Ensure that all training and study requirements are met prior to trial conduct.
- Assist with planning and creation of appropriate recruitment materials.
- Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.
- Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
- Complete visit procedures in accordance with protocol.
Other
- Ability to communicate and work effectively with a diverse team of professionals.
- Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail
- Critical thinker and problem solver
- Friendly, outgoing personality; maintain a positive attitude under pressure.
- High level of self-motivation and energy
