Care Access is looking to revolutionize access to clinical trials by connecting a network of research sites and physician investigators, nurse coordinators, and operations managers to accelerate medicine and create a long-term impact for generations.
Requirements
- Proficient at ICH/GCP, Good Documentation Practices (GDP), and ALCOA-C+
- Excellent working knowledge of clinical trials, medicine and research terminology
- Excellent working knowledge of federal regulations, good clinical practices (GCP), good documentation practices (GDP), and ALCOA-C+
- Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word, and excel.
- Proficiency with technology used to support the clinical trial industry. CTMS systems like CRIO, clinical conductor, Clinical Ink; EDC systems like MediData, Oracle, and Inform; ePRO, eConsent and IWRS/IXRS, etc.
- A minimum of 3 to 4 years Clinical Research experience
- A minimum of 2 years prior Clinical Research Coordinator experience, management level preferred.
Responsibilities
- Utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.
- Review and assess protocol, study manuals, and the investigator drug brochure (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc.
- Assist PI, Regulatory, Start-up and the Clinical Trial Manager(s) to ensure that all training and study requirements are met prior to trial conduct.
- Maintain organized file for source documents, patient charts, CRFs, regulatory and study supplies
- Collect and process, and ship biological specimens as directed by protocol and/or laboratory manual.
- Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment
- Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP
Other
- Extensive travel required. Candidates must be willing to travel 75% of the time nationwide.
- 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
