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. The Travel Clinical Research Coordinator will be instrumental in this mission by ensuring protocol and regulatory compliance in clinical research studies, particularly within Care Access's decentralized clinical research process.
Requirements
- Proficient at ICH/GCP, Good Documentation Practices (GDP), and ALCOA-C+.
- Strong working knowledge and experience in the clinical research industry.
- 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.
- Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word, and excel.
- Ability to work independently in a fast-paced environment with minimal supervision.
- 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.
- Collect, process, and ship biological specimens as directed by protocol and/or laboratory manual.
- Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.
- 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.
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.
