Job Description
JOB SUMMARY
A Clinical Research Assistant is an entry-level research position. This position is responsible for performing a variety of duties including coordinating aspects of clinical trial protocols including but not limited to study initiation, recruitment, study visits, monitor visits, regulatory compliance, and study close-out.
RESPONSIBILITIES
- Act as a liaison between providers, study representatives, and patients.
- Maintain case report forms, source documents, and regulatory documents.
- Maintain stock of supplies needed to carry out protocols.
- Pack and ship patient labs and review lab results.
- Provide patient care and collect medical information during visits.
- Initiate and participate in the informed consent process.
- Conduct screening of prospective study participants and schedule appointments of patients interested in research studies.
- Identify potential research participant candidates utilizing various channels including medical records, databases, referrals, and community outreach to identify potential candidates for participation in clinical research studies.
- Obtain informed consent (if required and appropriately delegated) from eligible participants according to established guidelines and protocols, ensuring comprehension and compliance with ethical standards and regulatory requirements.
- Conduct thorough remote screenings and assessments to determine initial patient eligibility for participation in clinical trials, coordinating with healthcare professionals as needed to verify medical history and suitability.
- Maintain detailed and accurate records of patient interactions, recruitment efforts, and consent processes in accordance with regulatory standards and study protocols.
- Collaborate closely with interdisciplinary team members including investigators, research coordinators, healthcare providers, and administrative staff to facilitate seamless recruitment and enrollment processes.
- Adhere to all relevant regulatory guidelines, institutional policies, and ethical standards governing the conduct of screening, recruitment, and enrollment in clinical research, prioritizing patient safety, privacy, and confidentiality.
- Use employee calendars to schedule appointments for patients.
- Instruct patients regarding study protocols.
- Arrange for or perform phlebotomy.
- Perform related work as required.
QUALIFICATIONS
- High School Diploma or equivalent. Bachelor's Degree preferred.
- 2+ years of experience in a clinical setting is a plus.
- Phlebotomy experience/certification preferred.
- Certified Nurse Assistant Certificate and/or graduation from an accredited program for medical assistants is a plus.
- Knowledge of Good Clinical Practices for clinical research is a plus.
- Knowledge of OSHA and FDA regulations regarding clinical research a plus.
- Maintaining confidentiality is a must.
- Knowledge of medical terminology is a plus.
- Knowledge of electronic medical records and scheduling systems a plus.
- Experience in working with providers and other department staff.
- Ability to apply and modify professional research principles, methods, and techniques to provide ongoing patient care.
- Skilled in identifying problems and recommending solutions.
- Understand common safety hazards and precautions for maintaining a safe working environment.
- Prepare/maintain records, write reports, respond to correspondence, and respond to e-mails.
- High level of computer competency.
- Ability to maintain quality control standards.
- Ability to react calmly and effectively in all situations.
- Ability to work independently, prioritize, and work in a team environment.
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