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Clinical Research Coordinator (Cellular Therapy) Phase I Clinical Trials

Children's National Medical Center
Washington, DC, District of Columbia 20010
  • Job Code
    S1006
  • Job Type
    Employee
  • Job Status
    Full Time

Children’s National Health System, based in Washington, DC, has been serving the nation’s children since 1870. Children’s National is Magnet® designated and was ranked among the top 10 pediatric hospitals by U.S. News & World Report 2015-16. Home to the Children’s Research Institute and the Sheikh Zayed Institute for Pediatric Surgical Innovation, Children’s National is one of the nation’s top NIH-funded pediatric institutions. With a community-based pediatric network, seven regional outpatient centers, an ambulatory surgery center, two emergency rooms, an acute care hospital, and collaborations throughout the region, Children’s National is recognized for its expertise and innovation in pediatric care and as an advocate for all children.

Mission Statement

As the nation’s children’s hospital, the mission of Children’s National Medical Center is to excel in Care, Advocacy, Research, and Education.

 

We accomplish this through:

  • Providing a quality health care experience for our patients and families.
  • Improving health outcomes for children regionally, nationally, and internationally.
  • Leading the creation of innovative solutions to pediatric health challenges.

Position Summary:

The Clinical Research Coordinator provides clinical trials regulatory support for the Center for Cancer and Immunology Research/Program for Cell Enhancement and Technologies for Immunotherapy (CETI). The program focuses on developing molecular and cellular therapeutic approaches to harness the power of the immune system to combat cancer. The research team is seeking an experienced Clinical Research Coordinator to participate in the coordination of multiple early phase clinical trials for the program. The CETI program strives to lead the biomedical revolution by fueling discovery and innovation to advance pediatric health.

Duties include:

  • Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.
  • Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
  • Coordinate collection of study specimens and processing.
  • Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
  • Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure institutional Review Board renewals are completed.
  • Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
  • Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
  • Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
  • Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
  • Participate in monitor visits and regulatory audits.
  • Other duties may also be assigned

 

Requirements

Minimum Education

Bachelor's Degree in health sciences, clinical research or applicable discipline. Knowledge of the biological or health sciences gained through advanced education (e.g., M.A., M.S., M.P.H., M.S.N., N.P., P.A., Ph.D.) or equivalent training is preferred

Specific Requirements and Preferences

  • Minimum 1-3 years of applicable work (e.g., research, clinical, interaction with study population, program coordination); Work requires at least 1-3 years of experience implementing and/or overseeing Phase I through Phase III trials.
  • Previous experience with investigator-initiated or pharma-sponsored clinical trials in oncology preferred
  • Candidates will be required to obtain an appropriate research certification (e.g., CCRP, CCRC, CCRA or CHRC) within one year of hire.

Interested candidates should send their resumes to Fahmida Hoq by e-mail: FHoq@childrensnational.org

We offer a competitive salary and benefits package. Equal Opportunity Employer of Minorities, Females, Protected Veterans, and Individual with Disabilities

 

 

Categories

Posted: 2019-05-14 Expires: 2019-06-13

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Clinical Research Coordinator (Cellular Therapy) Phase I Clinical Trials

Children's National Medical Center
Washington, DC, District of Columbia 20010

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