Clinical Research Assistant

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.
• 2-5 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.