Oncology Research Regulatory Operations Coordinator
Saint Joseph Mercy Health System

Employment Type:
Full time
Shift:
Day Shift

Description:

POSITION PURPOSE

Responsible for direct coordination of all 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 coordinator 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 regulatory compliance and requirements for participants registered to a wide variety of pharmaceutical clinical trials (30+) from all MCRC affiliated hospitals. Reviews clinical trial requirements and ensures acceptable standards per study sponsor and federal guidelines.
• Coordinates with study sponsors to answer questions posed by the staff or investigators, provide information on MCRC SOP's and act as the liaison to clinical team.
• Consults with national research bases and industry sponsors related to protocol on behalf of investigators and patients to assure compliance with protocol and patient safety.
• Provides training, direction, education, orientation to study staff and investigators at all sites affiliated with the Michigan Cancer Research Consortium.
• Coordinates audits and monitoring visits. Ensures that all documentation is available and submitted for auditor review. Follows up on all necessary corrections.
• Represents MCRC at National Meetings and Industry Sponsored events related to clinical trials.
• Recognizes and reports potential adverse events and protocol deviations in cooperation with the Research Nurses, Sub-Investigators, and Principal Investigator.
• Acts as liaison between the Institutional Review Board (IRB), Investigator, clinical departments, and the pharmaceutical sponsor.
• Creates, revises, and submits IRB submissions prior to deadline and communicates submission results to study sponsors and study staff following approval.
• Serves as liaison to other hospitals, outside organizations, and industry representatives on related research study or clinical trial issues.
• Communicates with other areas in the hospital to obtain documents needed to be maintained within study files such as the Lab for reference ranges or certifications held.
• Prepares and maintains Medicare Cost Analysis forms in compliance with research billing needs for pharmaceutical studies prior to opening for enrollment.
• Maintains good rapport and cooperative relationships. Approaches conflict in a constructive manner. Helps to identify problems, offer solutions, and participate in their resolution.
• Maintains the confidentiality of information acquired pertaining to patient, physicians, colleagues, and visitors to St. Joseph Mercy Health. Discusses patient and hospital information only among appropriate personnel in appropriately private places.
• Behaves in accordance with the Code of Conduct, Service Excellence Standards, and the Mission, Vision, Values and policies of SJMH.
• Assumes responsibility for performance of job duties in the safest possible manner, to assure personal safety and that of coworkers, and to report all preventable hazards and unsafe practices immediately to management.

OTHER FUNCTIONS AND RESPONSIBILITIES

Performs other duties as assigned.

REQUIRED EDUCATION, EXPERIENCE AND CERTIFICATION/LICENSURE

Education: Bachelor's Degree, preferably in a legal, regulatory or science-based field.

Experience: No experience required. Related data, health care, or previous research experience preferred.

Certification/Licensure: None.

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 organization, time management and document management skills. Ability to meet set monthly deadlines. Knowledge of research design, regulatory requirements, and ethical requirements. Working knowledge and utilization of Microsoft computing tools and good basic computer skills, including use of web conferencing and web-based collaboration tools. Ability to work both independently and in team-oriented settings. Ability to work flexible hours (typically within 8am-5pm) to accommodate study needs and meetings

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.

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