STUDY COMMUNICATIONS AND EDUCATION:

• Prepares and presents study materials to members of the interdisciplinary team regarding general research procedures and study specific elements of a protocol.
• May train new staff in preparation & conduct of clinical trials by providing oversight and guidance.
• Provide ongoing study specific training to other staff members to assure patient safety and adherence to the protocol.
• Helps develop strategies to ensure increased study awareness and subject screening and enrollment.

KNOWLEDGE, SKILLS & ABILITIES:

• Excellent written and verbal communication skills: Ability to collaborate with physicians, study sponsors, and other stakeholders.
• Advanced Clinical Research Knowledge: In-depth understanding of clinical research protocols, Good Clinical Practice (GCP), and regulatory requirements (FDA, IRB, guidelines).
• Strong knowledge of informed consent processes, ethical guidelines, and patient confidentiality standards.
• Ability to handle complex or high-risk patient interactions with empathy and professionalism.
• Skilled in Leadership and Team Collaboration: Ability to train and mentor junior coordinators and research assistants.
• Skilled in Problem-Solving and Critical Thinking.
• Time Management and Organizational Skills.

MINIMUM QUALIFICATIONS

• Bachelor’s degree or equivalent advanced learning attained through professional level experience required.
• Five (5) years of relevant work experience, or equivalent combination of education and work experience.

PREFERRED QUALIFICATIONS

• Patient Interaction and Recruitment: Expertise in recruiting and screening participants, managing informed consent, and conducting patient visits.
• Bilingual in Spanish and English.
• Certified phlebotomist or previous medical assistant experience.
• Experience in human subjects research.
• Certification with SoCRA, ACRP.
• Experience with research protocols, development, and regulations.
• Motivated to provide high-quality, compliant research.
• Previous research experience working in the area of cardiovascular.
• Demonstrated experience working within clinical/translational teams and project management.

ADMINISTRATIVE AND TEAM LEAD RESPONSIBILITIES:

• Assist Principal Investigator in developing clinical trial protocols and submit the required documentation to the Institutional Review Board, the University, and corporate or government sponsors.
• Develops and maintains protocol information and data/collection tools.
• Order and maintain supplies required for study kits, track spending in this area, and make day-to-day decisions in support of the study.
• Assist physician and/or principal investigator in preparation of study data/materials for publication and/or presentation of materials at conferences.
• Actively participate in clinical research team meetings.
• Provide oversight and strategic direction for assigned studies, ensuring protocol adherence, recruitment effectiveness, and regulatory compliance, while coordinating efforts of supporting team members as needed.
• Assign tasks and monitor the performance of junior coordinator to ensure alignment with study objectives and timelines.
• Develop and implement training materials for new staff members, emphasizing patient safety, ethical considerations, and protocol-specific elements.