Clinical Research Associate II
Job description
Join the HJF Team!
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.
This position will be in support of the Murtha Cancer Center Research Program (MCCRP) of the Uniformed Services University of the Health Sciences (USUHS). The John P. Murtha Cancer Center at Walter Reed Bethesda is a modern, patient-centric, tri-service military healthcare facility. Its comprehensive core of military and civilian oncologists and other cancer- trained clinicians and researchers provide multidisciplinary cancer-care delivery and patient-family support services. Our Cancer Center, the only DoD Cancer Center of Excellence within the Military Health System, offers its patients access to cutting-edge cancer diagnostic and treatment technologies.
The Research Protocol Coordinator (Research Associate II) will be responsible for assisting in the development and compliance of MCCRP research studies with applicable regulations for human subjects’ research in collaboration with MCCRP professional staff.
Note: This site requires that the incumbent has lived in the US for three out of the past five years.
- Contributes to the development and Institutional Review Board (IRB) submission of research protocol applications and consent forms on behalf of the study Principal Manages protocol writing, obtaining the required institutional approvals, and all phases of the protocol lifecycle to ensure that protocol amendments, continuing reviews and adverse events are submitted to the IRB in a timely manner.
- Ensures that protocol and regulatory documents are maintained and are kept up to Maintains study compliance with established local, state, federal, and DoD regulations for human subjects’ research with institutional regulatory direction from USUHS, WRNMMC and HJF. Maintains complete and accurate regulatory-compliant program/study binders.
- Performs initiation, tracking, management, and close-out of research Completes monitoring reports and follow-up letters, providing summaries of the significant findings, deviations, deficiencies, and suggests actions to obtain compliance as needed.
- Collects and monitors required research training certifications and other study personnel documents for MCCRP investigators and study team
- Performs quality control, research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring that Good Clinical Practices (GCP) are adhered to and communicating protocol deviations appropriately per Standard Operating Procedures (SOP), GCP and applicable regulatory requirements.
Required Knowledge, Skills and Abilities
- Basic knowledge of human subjects’ research regulations
- Excellent writing skills (able to clearly and concisely explain scientific and technical ideas in simple language).
- Strong organizational and time management skills
- High level of attention to detail
- Excellent communication and interpersonal skills (able to interact and communicate effectively with experts in medical, academic, research, technical, military, and administrative fields)
- Proficiency with computer applications such as MS Word, Excel, PowerPoint, and Adobe
Qualifications:
- This position will take place primarily in a office or clinic setting.
- Master's Degree required
- Minimum of 3 to 5 years experience required
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(c)
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.
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