- Conduct daily clinical operations of assigned research studies in accordance with study protocols, regulatory and GCP guidelines, and institutional policy.
- Develop and maintain tools for study implementation, including data collection tools, reference materials and specific study orders; revise and utilize tools as necessary.
- Create and disseminate study-related educational content for internal and external audiences to ensure safe and accurate protocol implementation.
- Coordinate patient sample receipt and testing by reviewing enrolling sites' information, sample quality and eligibility, ensuring complete documentation, and maintaining accurate records on samples, quality, workflow, data, and variance/deviation tracking per FDA-IDE requirement.
- Ensure administrative compliance with study protocols with respect to clinical procedures, laboratory tests and other patient activities as relevant.
- Complete clinical requisition forms as instructed, assemble kits for patient samples, transport laboratory samples and ensure samples are processed and shipped according to study guidelines; track and maintain research supplies.
- Identify, track and confirm billable activities for patients; work with internal partners to obtain and submit budget and billing information; may assist in reviewing patient charges to ensure billing compliance.
- Act as protocol liaison with clinical teams, patients, and providers on study related topics.
- Prepare and coordinate monitoring visits and respond to queries and other requests from study monitors, following up with and resolving any issues that may arise.
- Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature and maintaining professional associations. May travel to attend investigator meetings.
- Assist with maintaining appropriate source documentation and/or performing data entry, data analysis, and data auditing.
- Other duties as assigned.
- High School diploma
- Minimum two years' experience in a clinical research, clinical laboratory, or cancer registry environment with regulatory or human research protections.
- Knowledge of clinical trials records, procedures, and computerized data processing systems.
- Excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment.
- Collaborative focus is essential, as well as strong written and verbal communication skills, including computer skills.
- Ability to work with multiple data management systems including generating reports and sourcing data from systems.
- Ability to extract data from medical records.
- Ability to apply judgement in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.
- Associate or bachelor's degree or equivalent.
- Certified Clinical Research Coordinator (CCRC), certification as Clinical Research Professional (SOCRA), or certification in Cytogenetics or Molecular Testing by ASCP (CpG or MB).
- Demonstrated knowledge of how to synthesize study conduct.
- Minimum five years of experience in a research environment with regulatory or human research protections.
- Previous experience working with NIH, FDA and OHRP regulations and medical terminology.
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Clinical Research Coordinator II - Seattle, United States - Fred Hutchinson Cancer Research Center
Description
Overview
Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases.
With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers.
Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states.
Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality.
At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion.Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter.
Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.
The Clinical Research/Data Coordinator ensures all administrative and day-to-day operations of investigator-initiated and/or Government-sponsored human subject clinical trials are completed in a timely and compliant manner; as well as data integrity and completion.
This individual will work under general and limited supervision of the Principal Investigator or Key Co-investigator and will be required to perform his/her responsibilities with a high level of independence within the scope of study protocol(s) and institutional policies and guidelines.
This individual is responsible for the collection, coordination, processing, organizing and quality control of clinical trial data in accordance with protocols subject to FDA oversight.
ResponsibilitiesREQUIRED QUALIFICATIONS
PREFERRED QUALIFICATIONS
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.
The hourly pay range for this position is from $30.30 to $45.43 and pay offered will be based on experience and qualifications.
Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation days per year), paid sick leave days per year), paid holidays (13 days per year), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).
Our Commitment to DiversityWe are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected.
We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class.
We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to Human Resources at or by calling
