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.