About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit www.CareAccess.com.
How This Role Makes a Difference
The Clinical Research Coordinator’s primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.
How You'll Make An Impact
- Duties include but not limited to:
- Study Management
- Prioritize activities with specific regard to protocol timelines
- Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
- Maintain effective relationships with study participants and other care Access Research personnel.
- Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.
- Communicate clearly verbally and in writing.
- Patient Coordination
- Prescreen study candidates
- Obtain informed consent per Care Access Research SOP
- Complete visit procedures in accordance with protocol.
- Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
- Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.
- Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
- Documentation
- Record data legibly and enter in real time on paper or e-source documents
- Accurately record study medication inventory, medication dispensation, and patient compliance.
- Resolve data management queries and correct source data within sponsor provided timelines
- Assist regulatory personnel with completion and filing of regulatory documents.
- Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
The Expertise Required
- Excellent working knowledge of medical and research terminology
- Excellent working knowledge of federal regulations, good clinical practices (GCP)
- 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
- Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.
- Critical thinker and problem solver
- Friendly, outgoing personality; maintain a positive attitude under pressure.
- High level of self-motivation and energy
- Excellent professional writing and communication skills
- Ability to work independently in a fast-paced environment with minimal supervision.
Certifications/Licenses, Education, and Experience:
- Minimum Education:
- Bachelor’s Degree preferred, or equivalent combination of education, training and experience.
- Minimum Experience:
- 3 years prior Clinical Research Coordinator experience required
- Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator
- Recent phleboto
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