Senior Clinical Research Associate (Austere environments Consortium for Enhanced Sepsis Outcomes)

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Updated: November 5, 2019
Job ID: 215248
Status: Full-Time
Regular/Temporary: Regular
Location: Bethesda, MD, United States

Join the HJF Team!

HJF is seeking a Senior Clinical Research Associate to join the Austere environments Consortium for Enhanced Sepsis Outcomes (ACESO) located in Bethesda, Maryland. HJF provides scientific, technical and programmatic support services for the worldwide ACESO program.

 ACESO aims to improve survival for patients with sepsis through the development of host-based diagnostic and prognostic assays and evidence-based clinical management. The Senior Clinical Research Associate is responsible for ensuring good clinical practice and compliance in the implementation of ACESO clinical research studies.

Responsibilities: 

  1. Facilitates information flow and maintains the relationships between Principal Investigators and research staff, administrative staff, Institutional Review Boards (IRBs), research administration offices, Food and Drug Administration (FDA), Office of Human Research Protections (OHRP), and Foundation corporate offices.
  2. Manages the process of clinical protocol preparation, submission, and ethical review to include tracking and coordination to ensure compliance with relevant federal and local regulations and polices of research involving human subjects.
  3. Develops and maintains standard operating procedures and study specific procedures in conjunction with the PI and study team.
  4. Conducts site initiation training and refresher training as needed to international study sites. 
  5. Conducts site monitoring visits to ensure compliance with regulations and human subjects protection. Communicates regularly with sites by email and phone.
  6. Maintains a regulatory database to include data entry, queries and reports. Ensures that the database is current at all times.
  7. Assists the PI with compliance, regulatory, and research training activities for research personnel, including international study team personnel. 
  8. Actively participates and assists the research team with audits and monitors from sponsors, FDA, OHRP, and other governmental and/or military agencies.
  9. Monitors publications and website information from federal regulatory agencies to gain current information concerning changes in regulatory policy.  
  10. Completes other projects as needed.

Required Knowledge, Skills, and Abilities: Knowledge of federal and local regulations and policies pertinent to research involving human subjects; excellent communication, interpersonal and organizational skills; ability to utilize computer applications packages, such as MS Word, Excel, PowerPoint, and E-mail.

Minimum Education/Training Requirements: Bachelor’s degree in a scientific discipline or a related field required.  Nursing degree preferred, but not required. Must have completed training in human subjects protection in research. MPH would be a nice plus.

Minimum Experience: 6+ years-related experience in the area of human use and clinical research trial monitoring, to include monitoring in international research settings. 

Physical Capabilities: Must be able to utilize computer for lengthy periods of time; perform routine filing; standing for lengthy periods of time; must be able to travel to international and local sites occasionally.

Required Licenses, Certification or Registration: Certification as a Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA).

Work Environment: Office environment.  Travel can be anticipated to not exceed 25% of the time.

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.  

HJF is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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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