Job Description
Full-Time, 40 Hours/Week Monday to Friday, 8am - 4:30pm Hybrid (2-3 Days/Week Onsite) Summary The Clinical Research Assistant (CRA) is a research professional reporting to the Clinical Research Support Team Supervisor and working with and under the direction of Clinical Research Coordinator/Clinical Research Nurse, and Clinical Principal Investigator (PI) on ongoing research studies. While the PI is ultimately responsible for the clinical trial, the CRA will support diverse clinical trials and research studies and may have roles across the entire research continuum in accordance with federal, state, and local regulations, Institutional Review Board (IRB) approvals and Akron Children's Hospital (ACH) policies and procedures. The CRA plays a critical role in the conduct of the study and works collaboratively with the entire ACH Research team.
Responsibilities - Provide assistance in participant recruitment, screening, and follow-up for clinical trials.
- Utilizing Good Clinical Practice, the CRA ensures assigned study responsibilities are conducted in accordance with IRB and regulatory agency regulations.
- Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities.
- Completes timely and accurate data collection, documentation, entry, and reporting in both sponsor and ACH databases.
- Participates with the PI in scientific writing, preparation of research abstracts, manuscripts, presentations for academic audiences and grant applications.
- Specimen transporting, handling, processing, and shipping while maintaining correct records of specimen management and transport coordination according to protocol.
- Collaborates with multidisciplinary teams across the enterprise. Participates in team meetings and discussions to provide updates on project status and contribute to research strategic planning.
- Other duties as required.
Other Information Technical Expertise: - Knowledge of clinical trial protocols is preferred.
- Competency in interpreting medical charts and abstracting data is preferred
- Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures.
- Competency in the use of Microsoft Office, Word, and Excel, Electronic Health Systems, EPIC and databases utilized in research or have a willingness to learn and demonstrate proficiency within six months of hire.
Education And Experience - Education: Bachelor's degree or bachelor's eligible in a relevant field (e.g. Biology, Heath Sciences, Data Science, Public Health, etc.) is required.
- Strong interest in clinical research and healthcare
- Excellent communication skills, both written and verbal.
- Strong organizational abilities and attention to detail.
- Certification: None.
- Years of relevant experience: None
- Experience in research is preferred.
- CITI Certification – Certification is required within 90 days of hire.
- Ability to work independently as well as in a team environment.
Full Time
FTE: 1.000000
Job Tags
Full time, Work at office, Local area, 2 days per week, 3 days per week, Monday to Friday,