Research Coordinator II - Defense & Veterans Center for Integrative Pain Management

Henry M. Jackson Foundation, United States

Updated: over 2 years ago
Location: Houston, TEXAS
Deadline: The position may have been removed or expired!

Description

Join the HJF Team!

HJF is seeking a Research Coordinator II to support the Defense & Veterans Center for Integrative Pain Management (DVCIPM) located at the Brooke Army Medical Center in San Antonio, TX. HJF provides scientific, technical, and programmatic support services to DVCIPM. US citizenship is required.

Develops, edits, documents, and packages protocols, consent forms and other regulatory documents for assigned medical centers, and special projects located at DVCIPM headquarters. Responsible for the execution and completion of protocol compliance actions leading to final IRB Approval. Conducts data cleaning and basic statistical analyses and table preparation. Prepares manuscripts and conference presentations.

Responsibilities:

  • Writes protocol applications and consent forms for Institutional Review Boards. Prepares and submits required institution and federal documentation for the conduct of the trial. (20%)
  • Manages regulatory issues for all programs upon receipt of IRB approval. This includes preparing any addenda and/or annual progress reports, submitting adverse event/safety information to the IRB, updating/maintaining regulatory requirements such as updated investigator CVs, changes in principal investigator, FDA form 1572, etc. Also, maintains accurate, regulatory-compliant program/study binders. (45%)
  • Performs research on background material pertaining to the clinical trials and uses this research to complete all protocol submissions. (10%)
  • Performs the duties of a manuscript co-author, to include data cleaning, basic analyses and table generation, and manuscript preparation. (5%)
  • Coordinates efforts of all agencies involved in the protocol approval process. Makes and maintains contacts within the military health system and Henry Jackson Foundation and other collaborating contractors or partners. (10%)
  • Coordinates protocol-specific training to study site staff and investigators. Ensures all human research protection (HRP) education is current, per study/project needs. Assists and leads in the drafting standard operating procedures (SOPs), coordinating in-services with clinical and research staff, and maintaining training logs within the scope of the research projects. (10%)
  • 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.

    • Required Knowledge, Skills and Abilities: Knowledge of procedures and techniques necessary for performing research tasks; ability to learn and become proficient in data acquisition and research responsibilities related to research protocols; excellent interpersonal skills; data management, cleaning, and analytic skills is preferred, especially using R. 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.

    Minimum Education: Bachelor’s degree is required. Master’s degree preferred.

    Minimum Experience/ Training Requirements: Minimum 6-8 years of relevant work experience required.

    Required Licenses, Certification or Registration: Certification as a Research Coordinator (CCRC) through SoCRA, ACRP or other.

    Work Environment: Set in an office and laboratory work environment.

    Background/Security: US Citizenship is required. Eligibility to obtain and maintain a Tier I investigation/Public Trust and a Common Access Card (CAC).

    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, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check. 

    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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