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Form of workThis position serves a critical role not only in planning and coordinating individual research studies but in monitoring regulatory compliance with the sponsor's protocol and FDA, HHS, CMS, California DPHS, as well as the policies of Saint Agnes Medical Center's IRB, Privacy Board, and Clinical Research Center (CRC). Overall, the incumbent will be part of a research team that includes the CMO, Service Line Leader, IRB Chairperson, Clinical Investigator(s), Medical Center staff, and the study's Sponsor. Specific duties will include the following: assisting the Investigator and/or staff member in completing and submitting research applications and updates to the IRB; coordinating the screening and enrollment of research subjects; establishment and management of study project and regulatory files; submitting required study reports (e.g., "Unanticipated Problems" and "Serious Unexpected Adverse Events", "Study Status", "Modifications", etc.) to the IRB; maintaining drug/device accountability logs; collecting and entering case report form data, and following up on Sponsor's data queries. The Coordinator will also be expected to effectively use Merge CTMS for the purposes of tracking patient visits/procedures, investigator earnings and payments, and departmental earned revenue, as well as ProIRB for the purposes of tracking IRB submissions, meeting actions, and generating IRB agendas, action letters, and meeting minutes. When necessary, the Coordinator may support the Investigator by performing a limited number of direct patient assessments which the Coordinator is qualified or certified to perform (e.g., phlebotomy, taking vital signs, collecting specimens). The full scope of the Coordinator's responsibilities will vary based on the Medical Center and Clinical Research Center's needs.
1. Depending on specific focus of Coordinator's job within the CRC, a Bachelor's Degree with three (3) years experience in coordinating clinical research activities is preferred, or five (5) years experience in coordinating clinical research activities with postsecondary education or certification in a health care provider specialty is required.
2. Should the focus of this Coordinator position involve direct patient care duties (e.g., phlebotomy or vital sign assessment), a current Certification in Phlebotomy (CPT) and current American Heart Association (AHA) Healthcare Provider CPR card are required within (6) months of hire.
3. Must possess strong organizational, analytical, oral and written communication and time management skills, as well as crosscultural sensitivity. Ability to prioritize in a fast-paced environment with attention to detail and quality is required.
4. Familiarity with medical terminology and clinical research methodology is required.
5. Proficiency with Microsoft applications (i.e., Excel, Word, Power Point, Access); basic knowledge of business/accounting practices; and the ability to learn new software applications such as Study Manager (for patient tracking) and ProIRB (for managing IRB activities) are required.
6. Demonstrated experience with federal and state regulations governing clinical research and institutional review boards, as well as demonstrated experience in ensuring compliance with such regulations, are required.
Pay Range ($31.63 - $47.45)
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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.
Education: []Employment Type: ["FULL_TIME"]
