Oncology Research Coordinator
Trinity Health
Employment Type:
Full time
Shift:
Description:
POSITION PURPOSE
Responsible for direct coordination of all eligibility confirmation, registration, data interpretation and reporting, laboratory specimens and regulatory requirements necessary for oncology research trials associated with the Michigan Cancer Research Consortium (MCRC). Works with all study sponsors (federal and industry) to assure MCRC sites meet all standards associated with Human Subjects and Federal regulations appropriate to clinical trials. Provides support to health care providers, clinical research nurses and ancillary departments to assure care is provided per protocol standards. Provides mentorship, training and professional guidance to investigators, other research coordinators and nurses at sub- recipient sites of the Michigan Cancer Research Consortium (14 hospitals in 3 states).
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
Provides direct coordination of all patient registrations for a wide variety of clinical trials (100) for all 14 MCRC hospitals. Reviews eligibility materials to ensure patient eligibility for each trial and that documentation meets acceptable standards per study sponsor and federal guidelines.
Provides consultation with and feedback to oncologists (medical, radiation and surgical), nurses and other research coordinators related to eligibility requirements for patients in a wide variety of pharmaceutical and National Cancer Institute sponsored oncology clinical research protocols
Abstracts and reports data in multiple electronic data capture systems per study specific direction. Provides consultation to research nurses and ancillary departments on study required documentation and submission guidelines.
Independently evaluates potential research study protocols for feasibility and resource capabilities. Coordinates with study sponsors to answer queries, provide information on MCRC SOPs and act as the liaison to clinical team.
Evaluates medical records to abstract patient information on performance status, response to investigational treatment and severity of toxicities based on protocol requirements
Consults with national research bases and industry sponsors related to protocol clarifications on behalf of investigators and patients to assure protocol compliance and patient safety
Provides training, education, orientation and supervision to research coordinators and nurses at all 14 sites of the Michigan Cancer Research Consortium Clinical Community.
Assures that research specimens are obtained and processed appropriately and works closely with pathology and interventional radiology departments regarding biopsies and tissue acquisition.
Assures radiologic images are uploaded into the appropriate database, and radiation treatment plans for participants are submitted to each research base per study specific guidelines.
Represents MCRC at National Meetings and Industry Sponsored events related to clinical trials
Analyzes and evaluates clinical data to assess for trends of potential adverse events. Recognizes and reports potential adverse events in cooperation with the research nurses, investigators and principal investigator.
Acts as patient advocate between the investigator, clinical departments and the cooperative groups.
Serves as liaison to other departments, outside organizations, and industry representatives on related research study or clinical trial issues.
OTHER FUNCTIONS AND RESPONSIBILITIES
Performs other duties as assigned.
REQUIRED EDUCATION, EXPERIENCE AND CERTIFICATION/LICENSURE
Bachelor’s Degree, preferably in science-based field. Two years of related data, health care, or previous research experience preferred.
REQUIRED SKILLS AND ABILITIES
Demonstrated ability to work closely with principal investigators and other stakeholders to coordinate the day-to-day activities required in study coordination. Excellent writing and interpersonal communication skills. Excellent organizational and troubleshooting skills. Ability to work both independently and in team-oriented settings. Knowledge of research design principles, statistics, regulatory requirements, and ethical requirements. Working knowledge of utilization of internet-based computer programs and good basic computer skills. Ability to work flexible hours to accommodate study and patient schedules.
Our Commitment to Diversity and Inclusion
Trinity Health is one of the largest not-for-profit, Catholic healthcare systems in the nation. Built on the foundation of our Mission and Core Values, we integrate diversity, equity, and inclusion in all that we do. Our colleagues have different lived experiences, customs, abilities, and talents. Together, we become our best selves. A diverse and inclusive workforce provides the most accessible and equitable care for those we serve. Trinity Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by law.
Our Commitment to Diversity and Inclusion
Trinity Health is a family of 115,000 colleagues and nearly 26,000 physicians and clinicians across 25 states. Because we serve diverse populations, our colleagues are trained to recognize the cultural beliefs, values, traditions, language preferences, and health practices of the communities that we serve and to apply that knowledge to produce positive health outcomes. We also recognize that each of us has a different way of thinking and perceiving our world and that these differences often lead to innovative solutions.
Our dedication to diversity includes a unified workforce (through training and education, recruitment, retention, and development), commitment and accountability, communication, community partnerships, and supplier diversity.
EOE including disability/veteran