Clinical Protocol Coordinator

Position Overview

The Clinical Protocol Coordinator will provide specialized genetic counseling and psychosocial support to patients and families affected by inherited diseases. The role includes communicating medical and genetic information, assessing psychosocial needs, developing family pedigrees, facilitating genetic testing and specimen collection, and coordinating with genetic counseling organizations and patient support groups. The coordinator will also support clinical and translational research, regulatory documentation, data analysis, and quality improvement.

Responsibilities

• Communicate medical, genetic, and psychosocial information to patients and families, including recurrence risk assessments and family-planning options.
• Conduct initial psychosocial assessments and refer patients for continued care as appropriate.
• Construct family pedigrees, contact family members, assist with obtaining genetic specimens, and facilitate clinical and research molecular testing.
• Coordinate with genetic counseling organizations and patient support groups.
• Assist with behavioral and genetic counseling research and the preparation and execution of clinical and translational research protocols.
• Review medical and scientific literature, organize and analyze research data, prepare manuscripts, and present findings at internal conferences and national or international scholarly meetings.
• Develop, assemble, write, edit, and review study protocols, amendments, study reports, audit documentation, and standard operating procedures (SOPs).
• Prepare and submit documentation to regulatory bodies and coordinate regulatory activities throughout the protocol lifecycle, from development through study closure.
• Track study requests, submissions, protocol approvals, and regulatory activities; maintain study databases and conduct basic analyses.
• Prepare, review, and submit clinical data to monitoring agencies.
• Review adverse event files for accuracy and completeness and prepare reports in accordance with Institutional Review Board (IRB) processes and policies.
• Maintain master participant lists, update enrollment status, assign study identification numbers, and obtain demographic information.
• Support ongoing clinical quality control and recommend improvements to the integration and delivery of genetic services.
• Evaluate the impact of legislation, publications, reports, and other information on current and planned genetic counseling activities and recommend appropriate actions.
• Develop training plans and train staff on protocol submission procedures.
• Advise investigators on the documentation and approvals needed to initiate clinical studies based on the study type, location, and complexity.
• Brief laboratory personnel on emerging genetics and genetic counseling issues and recommend responses.

Required Qualifications

• Master's degree in genetic counseling.
• Certification or board eligibility as a Genetic Counselor through the American Board of Genetic Counseling (ABGC).
• Ability to be credentialed by the NIH Clinical Center.
• Knowledge of patient privacy, privileged information, and secure handling of medical records.
• Proficiency with Microsoft Office.

Deliverables

• Perform validation activities monthly.
• Inspect equipment biweekly.
• Meet with laboratory members biweekly to present updates.