Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.
Requirements
- Proficient at ICH/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.
- Ability to understand and follow institutional SOPs
- Collect and evaluate medical records with the support of medically qualified members of the study team.
- Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion
- Proficient at recognizing adverse events (AEs) and Serious Adverse Events (SAEs)
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
- Where appropriate, Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document on accountability log and patient records
- Collect, process, and ship biological specimens as directed by protocol and/or laboratory manual.
- Accurately transcribe data to CRF or EDC.
Other
- Extensive travel required. Candidates must be willing to travel 75% of the time nationwide. Duties may require travel for a two-week stretch, followed by one week home. Frequency and length of travel may depend on the length and location of study.
- 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
- Friendly, outgoing personality; maintain a positive attitude under pressure
- High level of self-motivation and energy
