Summary

The Senior Clinical Research Coordinator – Genetics is responsible for independently managing the daily operations of complex clinical research studies within the Division of Pediatrics – Molecular and Human Genetics (Pediatrics – Genetics). This role leads patient enrollment, screening, and consent processes, ensuring compliance with regulatory standards and study protocols. The coordinator performs and oversees clinical procedures, manages data collection and reporting, and maintains accurate regulatory documentation.

This position will lead a complex clinical trial. Applicants should have advanced knowledge of clinical research and be able to operate in a highly independent manner with minimal oversight. Strong communication skills are essential, as the role requires regular interaction with internal and external stakeholders, including investigators, faculty, and sponsors.

The Senior Clinical Research Coordinator (Sr. CRC) must demonstrate proactive problem-solving abilities and effectively communicate across multiple departments within the College and with external organizations. The ideal candidate will be capable of managing a highly demanding and complex clinical study involving rapid scale-up and a high volume of patients/participants.

Job Duties

• Independently manage the day-to-day operations of complex clinical research studies across multiple therapeutic areas in Pediatric Genetics.
• Lead patient enrollment activities, including recruitment, screening, interviewing, and obtaining informed consent.
• Educate study participants and their families on study protocols, procedures, and expectations.
• Perform and document clinical procedures such as venipuncture, ECGs/EKGs, vital signs, and other protocol-specific assessments.
• Collect and record clinical data related to study procedures, including catheterizations, cardiac measurements, and diagnostic tests.
• Ensure timely and accurate data entry into electronic case report forms (eCRFs) and Clinical Trial Management Systems (CTMS).
• Schedule and coordinate study visits, laboratory tests, imaging, and other protocol-required procedures.
• Collect, process, store, and ship biological specimens in accordance with study protocols and IATA guidelines.
• Maintain and update regulatory documents, source documentation, and study records in compliance with FDA, IRB, and institutional requirements.
• Communicate regularly with study participants, families, investigators, and sponsors to ensure smooth study conduct.
• Interact with sponsors, coordinating centers, and regulatory agencies to facilitate study activities and maintain up-to-date documentation.
• Order, track, and manage study supplies, equipment, and investigational products.
• Review and interpret study protocols, abstracts, and informed consent forms for relevant operational and regulatory information.
• Communicate and follow up on serious adverse event (SAE) reports and other safety documentation.
• Collaborate with physicians, mid-level providers, research nurses, and data managers to ensure accurate and timely documentation of patient care.
• Participate in study feasibility assessments, including evaluation of staffing, patient population, and resource needs.
• Provide cross-coverage and support across the research portfolio as needed.
• Develop standard operating procedures (SOPs) and contribute to the continuous improvement of the clinical research process.
• Assist the regulatory team to ensure compliance with FDA, IRB, and institutional policies.
• Performs other job duties as assigned.

Minimum Qualifications

• Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
• Five years of relevant experience.

Preferred Qualifications

• Bachelor’s degree in Basic Science, Healthcare, Public Health, or a related field.
• Minimum of five years of experience in clinical research or healthcare settings.
• Certified Clinical Research Coordinator (ACRP) or Certified Clinical Research Professional (SOCRA).
• Proficient in EPIC electronic health record system.
• Hands-on experience with therapeutic clinical research studies.
• Strong knowledge of FDA Good Clinical Practice (GCP) guidelines.
• Familiarity with neurology-focused clinical research protocols and procedures.