Senior Clinical Research Associate - Ortho and Rehab

Join the HJF Team!

HJF is seeking a Senior Clinical Research Associate to monitor the execution of clinical trials associated with specific projects and ensure that all necessary steps are taken towards safety provisions and all regulations are adhered to.

This position will be in support of the Department of Orthopaedics within the Brooke Army Medical Center, JBSA Fort Sam Houston, located in San Antonio, TX.

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.

• Submits protocol application and consent forms on behalf of PI to local Institutional Review Board (IRB). Ensures that all amendments, continuing reviews and adverse events have been submitted to the IRB. Acting on behalf of the Principle Investigator (PI) holds the highest level of importance. This role requires editing, reviewing and interaction with multiple levels of review committees.
• Ensures that regulatory documents are maintained and are up to date Maintains accurate regulatory compliant program/study binders for each study. Responsible for updates and maintenance of regulatory requirements such as the investigator's CVs, changes in PI, FDA form 1572, training records, license etc.
• Performs qualification, initiation, monitoring, and closeout of study. Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and suggest actions to obtain compliance.
• Assures sufficient investigator qualifications, training, facility resources, laboratories, equipment, and staff to properly support studies. Ensures the site is identifying issues and implementing corrective and preventive actions to ensure inspection readiness.
• Performs research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring GCP are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements.
• Assesses the clinical research site's patient recruitment and retention success; offering suggestions for improvement.
• May supervise other Clinical Research Associates.
• May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.

Education and Experience

• Master's Degree required, preferably in healthcare of sciences related field.
• Minimum of 9-10 years experience is required.

Licenses and Certifications

• Certified Clinical Research Professional (CCRP) preferred.

Required Knowledge, Skills and Abilities

• Working knowledge of a broad range of medical specialties
• Working knowledge of all applicable federal and military regulations regarding the use of human and animal subjects in research (e.g.: 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 314,45 CFR 46, FDA Form 1571, and FDA Form 1572).
• Must be familiar with Institutional Review Board activities and Institutional Biosafety Committee actions.
• Must be able to set and meet deadlines.
• Experience working with trauma patients.
• Experience working in a surgical setting.
• Ability to obtain and maintain a T1/Public Trust background check.

Physical Capabilities

• Lifting: Requires lifting materials up to 15 lbs.
• Ability to stand or sit at a computer for prolonged periods.

Work Environment

• This position requires regular in-person availability for meetings and participant recruitment.
• This position will take place primarily in a hospital setting.

Compensation

• The annual salary range for this position is $88,600 - $90,000. Actual salary will be determined based on experience, education, etc.

Benefits

• HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more.

Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.