Genetic Counseling Protocol Coordinator

Axle; Bethesda (MD); On-site; USD 130,000 - 140,000; Full time

Benefits offered by this job

Paid Time Off

401K match up to 5%

Educational Benefits for Career Growth

Employee Referral Bonus

Flexible Spending Accounts: Healthcare

Parking Reimbursement Account

Dependent Care Assistant Program

Transportation Reimbursement Account

Job summary

Axle in Bethesda, MD, seeks a Clinical Protocol Coordinator to join NIH/NIAID. The role provides genetic counseling and psychosocial support to patients and families affected by inherited diseases, coordinating testing, family pedigrees, and regulatory documentation.

You will contribute to clinical and translational research, analyze data, prepare protocols and SOPs, and support regulatory activities throughout the study lifecycle, while ensuring privacy and quality standards.

Qualifications

• Master’s degree in genetic counseling.
• Certification or board eligibility as a Genetic Counselor through the ABGC.
• Ability to be credentialed by the NIH Clinical Center.
• Knowledge of patient privacy and secure handling of medical records.
• Proficiency with Microsoft Office.
• Perform validation activities monthly.
• Meet with laboratory members biweekly to present updates.

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 conferences.
• Develop, assemble, write, edit, and review study protocols, amendments, study reports, SOPs.
• Prepare and submit documentation to regulatory bodies and coordinate regulatory activities throughout the protocol lifecycle.
• 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 per IRB processes.
• Maintain master participant lists and update enrollment status.

Skills

Microsoft Office proficiency

Education

Master’s degree in genetic counseling

Tools

NIH/Regulatory systems

Job description

Axle in Bethesda, MD, seeks a Clinical Protocol Coordinator to join NIH/NIAID. The role provides genetic counseling and psychosocial support to patients and families affected by inherited diseases, coordinating testing, family pedigrees, and regulatory documentation.

You will contribute to clinical and translational research, analyze data, prepare protocols and SOPs, and support regulatory activities throughout the study lifecycle, while ensuring privacy and quality standards.