Research Protocol Coordinator I, II, or III - Bethesda, United States - Henry M. Jackson Foundation

Henry M. Jackson Foundation Bethesda, United States

3 weeks ago

Description

Overview

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.

HJF is seeking a Research Protocol Coordinator I, II, or III (multiple openings) to support the Murtha Cancer Center Research Program (MCCRP) located at the Rockledge Office in Bethesda, MD.

The mission of MCCRP is to improve the diagnosis and multidisciplinary treatment of DoD cancer patients through innovative translational research, evidence-based translational care, and education.

HJF provides scientific, technical and programmatic support services to the MCC.

The Research Protocol Coordinator 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 work site requires that Non-US Citizen incumbents have lived in the US three out of the past five years.

Responsibilities

Contributes to the development and Institutional Review Board (IRB) submission of research protocol applications and consent forms on behalf of the study Principal Investigator. Manages protocol writing, obtaining the required institutional approvals, and all phases of the protocol life cycle 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 date. 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 studies. Completes monitoring reports and follow-up letters, providing summaries of the significant findings, deviations, deficiencies, and suggesting actions to obtain compliance.
Monitors the execution of clinical trials associated with specific projects. Ensures that all necessary steps are taken towards safety provisions and all regulations are followed.
Collects and monitors required research training certifications and other study personnel documents for MCCRP investigators and study team members.
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.
Performs tasks associated with the institutional publication clearance process for MCCRP manuscripts, posters, and conference presentations; tracks MCCRP scientific publications and provides regular reports to institutional leadership.
May perform other duties and responsibilities as assigned or directed by the supervisor. This may include participation in required training for role or assisting in training other Associates on the study team.

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 skills and 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).
Strong time management skills.
Proficiency with computer applications such as MS Word, Excel, PowerPoint and Adobe Acrobat.

Qualifications

Work Environment

This position will take place primarily in a office/laboratory setting.

Education and Experience

Master's degree required.
Level I: 0-2 years of experience required.
Level II: 3-5 years of experience required.
Level

III:
6-8 years of experience required.

Licenses and Certifications

Certified as a Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) preferred.

Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be 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 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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