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 Clinical Research Coordinator will facilitate the planning, coordination, and implementation of investigator-initiated and industry- sponsored clinical research studies involving human subjects. The incumbent will have daily interaction with faculty, study team, pharmaceutical sponsors, physicians, other health care personnel, and patients as a representative of the active and growing hematologic malignancy research program and will be expected to create and maintain cross-functional working relationships with internal teams and external partners.
Under the supervision of the Clinical Trials Manager, this positon will manage a portfolio of complex interventional clinical protocols and will be required to perform his/her responsibilities with a high level of independence within the scope of study protocol(s) and institutional guidelines.
1. Principal Investigator Support:
- Serve as designee of the Principal Investigator (PI) to manage the daily clinical operations of assigned research studies in accordance with regulatory, GCP guidelines and institutional policy.
- Review study candidates' medical records for study eligibility and assist in screening and patient enrollment.
- Attend weekly team meetings and communicate regularly with PI on study status.
2. Protocol Implementation and Study Management
- Develop and maintain tools for study implementation, which may include data collection tools, study reference materials, and study specific orders. Revise and utilize tools as necessary to fulfill the aims of the clinical trial.
- Ensure study related clinical procedures such as blood draws, infusions and treatment are scheduled according to protocol requirements; coordinate with clinic staff to ensure proper documentation and timing of research-related procedures in accordance with the protocol.
- Complete requisition forms, assemble kits for upcoming research visits, transport laboratory samples, and ensure samples are processed and shipped according to study specific guidelines, while tracking and maintaining research supplies.
- Attend all necessary internal implementation meetings and coordinate Site Initiation Visit (SIV) with sponsor.
- Educate clinical teams, ancillary departments, and patients to ensure safe and accurate protocol implementation.
- Ensure informed consent, initiate patient enrollment, and maintain accurate enrollment records.
- Research, maintain, analyze, and abstract patient clinical trial data from pre-study background (e.g., previous diagnoses and treatments) through clinical trial participation and long-term follow-up. Maintain appropriate source documentation and complete accurate data entry into case report forms in a timely manner.
- Coordinate and support regularly scheduled Sponsor or institutional monitoring visits to ensure quality and completeness of data. Respond to all findings and implement corrective action plans as necessary.
- Identify and report adverse events in accordance with protocol, regulatory guidelines, and institutional policy.
- Manage long-term follow-up evaluations and data collection with clinical trial participants, SCCA, and participants' local physicians.
- Assist with preparation of IRB and other regulatory documents as required. Sustain ongoing communication with the Regulatory Coordinator to ensure study compliance and patient safety.
- Remain current on institutional, regulatory and clinic guidelines and policies which may impact study conduct. Provide input on improvement processes and other initiatives as requested.
3. Other Duties Which May Be Required
- Assist the Principal Investigator (PI) with protocol development, revision, and study analysis.
- Collaborate with Investigational Drug Services (IDS) on drug assignment, dispensation information, and maintain regular communication regarding status of study subjects.
- Ensure study drug self-administration and accountability with patients.
- Perform non-clinical ECGs.
- Administer study questionnaires.
- Function as a protocol liaison with clinical teams, patients, and when necessary, other institutions or industry partners.
- Work with internal partners to obtain and submit budget and billing information. Understand clinical trial budget and billing plans for patients enrolled on clinical trials. Participate in the review of charges for patients on clinical trials to ensure billing compliance.
- Travel for industry sponsored investigator meetings.
- Maintain thorough knowledge in the field by attending related project meetings and symposia, reading related literature, and maintaining professional associations.
- Provide cross-coverage and serve as back-up coordinator for study teams in other disease groups as needed.
- Perform other responsibilities as assigned.
The ideal candidate will possess the following qualifications:
- BA/BS required; scientific field of study helpful.
- Applicant must have a minimum of 1-2 years of clinical research or related experience.
- Medical background, prior experience in oncology research, and/or experience in clinical data collection is strongly preferred.
- Working knowledge of Good Clinical Practice, human subjects research, and medical terminology preferred.
Key Skills and Abilities:
- This position requires superior communication skills, precise attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment.
- Collaborative focus is essential; flexibility, ability to work independently, excellent organizational skills, and proficiency in MS office are required.
If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2364531-2647-2021