Clinical 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 is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).

Axle is seeking a Clinical Protocol Coordinator to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Allergy and Infectious Diseases (NIAID) located in Bethesda, MD.

Benefits We Offer:

• Paid Time Off and Paid Holidays
• 401K match up to 5%
• Educational Benefits for Career Growth
• Employee Referral Bonus
• Flexible Spending Accounts:
  • Healthcare (FSA)
  • Parking Reimbursement Account (PRK)
  • Dependent Care Assistant Program (DCAP)
  • Transportation Reimbursement Account (TRN)

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.

Perform validation activities monthly.

Meet with laboratory members biweekly to present updates.

Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.

The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.

Accessibility: If you need an accommodation as part of the employment process please contact: [e-mail]

This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate’s experience, qualifications, skills, and location.

Salary Range: $130,000 USD - $140,000 USD