Data Coordinator II (Assistant Research Coordinator)

Organization
Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance
Job Location
Seattle, WA
Job Description

Cures Start Here.
At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first and largest cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network.

Careers Start Here.
The Assistant Research Coordinator will work with the research team to collect clinical data from medical records and research charts, and work closely with the physicians and research staff in providing administrative, technical and data entry support for research projects. In addition, the Assistant Research Coordinator is responsible for preparing and managing regulatory documentation for industry sponsored, investigator initiated and national cooperative group clinical trials.

This position must be able to work independently on multiple research projects. This position requires daily interaction with physicians, other health care personnel (e.g. nurses, patient care coordinators, patient service representatives, and medical assistants), pharmaceutical company sponsors and any other groups integral to the successful completion of the data needs for the research project.

This position coordinates and monitors clinical trial regulatory activities in support of a significant number of complex interventional clinical protocols and supports compliance with regulatory documentation requirements for the conduct and sponsorship of FDA-regulated studies.

This position is supervised by and reports to the Research Manager and works directly with the Lead Study Coordinator.

The Assistant Research Coordinator position requires understanding of the research protocols and translation of the research needs into appropriate data and regulatory requirements. She/He will integrate information from multiple sources and use specialized regulatory knowledge to ensure all clinical trials are compliant with applicable federal and institutional regulation and that data is reported accurately and in a timely manner.

- Work independently, or with guidance from the Lead Study Coordinator as appropriate, to obtain, abstract, and code complex clinical information from multiple sources (medical records, research records, etc.) for research subjects. Code and record said information into various study-specific data-capture systems (both electronic and paper-based). Resolve and answer data queries in collaboration with the study coordinator as applicable.
- Record adverse events and report serious adverse events according to sponsor guidelines. Follow up on reports as required. Request further information from provider, other clinical staff, and outside facilities as needed to accurately complete records and reports.
- Serve as the primary contact for study sponsor in arranging site qualification visits, site initiation visits, and periodic study monitoring.
- Request medical records from outside medical facilities as necessary and
- Independently maintain and track laboratory sample supplies, complete requisition forms, and assemble kits for upcoming research subject visits for assigned clinical trials
- Prepare, track, and maintain all correspondence and regulatory documentation required by the Institutional Review Board (IRB), FDA, and other institutional and federal oversight committees.
- Oversee, coordinate and ensure compliance with ongoing reporting requirements including IRB submissions, annual reports, study amendments, safety reports, and unanticipated problem/noncompliance reports. This includes submissions to all institutional governing bodies as applicable, including but not limited to the Institutional Biosafety Committee, the Institutional Radiation Safety Committee, and the Scientific Review Committee.
- With input from the PI, draft initial clinical research trial consent forms in accordance with CFR, FDA, and institutional guidelines, ensuring inclusion of all appropriate "Elements of Informed Consent." Translate complicated research protocol requirements into language easily understood by research participants. Obtain approval from sponsors for consent forms.
- Maintain regulatory binders including the update of all required regulatory documents (e.g. FDA form 1572 and/or 1571, signature pages and letters of acknowledgement, investigator brochure, financial disclosure forms, laboratory accreditations, laboratory reference ranges, investigator and research staff CVs, medical licenses, and related forms) per sponsor, federal, and institutional requirements.
- Develop and maintain study-specific procedures for third-party safety report review and acknowledgement.
- Communicate with investigator and study team concerning the status of regulatory approvals and changes in protocols, consent forms, and other study documents, as well as status of projects and priorities.
- As needed, may be required to oversee drug self-administration by patients, conduct non-clinical ECGs, and administer study questionnaires.
- Provide coverage for Lead Study Coordinator as needed.

- BA/BS, RRA (Registered Records Administrator), ART (Accredited Records Technician), or two year degree in the medical field.Bachelor's Degree strongly preferred.
- A minimum of two years of experience in medical records, cancer registry, or related field
- Previous experience in research or clinical data collection is strongly preferred.
- Priority will be given to candidates with a strong regulatory background and prior experience with oncology/hematologic malignancy clinical trials, and knowledge of medical terminology.
- This position requires excellent organizational skills, strong problem-solving capabilities, and the ability to prioritize multiple competing tasks in a dynamic environment.
- Must be able to take direction from Lead Study Coordinator as well as work independently. The willingness to work as part of a cohesive team is essential.
- Strong written and verbal communication skills including computer skills are necessary.

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