Clinical Research Regulatory Coordinator II
The Clinical Research Regulatory Coordinator II is responsible, for the coordination and oversight of regulatory requirements of clinical research protocols. Under the direction of the Clinical Research Regulatory Manager and in conjunction with the Principal Investigator (PI) and other study team members, the Clinical Research Regulatory Coordinator II exhibits increased learned skills and flexibility in performing duties, and assumes responsibility for a portfolio of clinical research protocols.
JOB DUTIES AND RESPONSIBILITIES:
Prepare all regulatory documentation, document filing, tracking and maintenance. Responsibilities include:
Documents new study in REDCap tracking system.
Maintains all logs, including OnCore, according to University of Rochester (UR) and department Standard Operating Procedures (SOPs).
Collects all regulatory documents required to submit to the DWG and PRMC and collates essential regulatory documents within Complion.
Prepares/drafts ICF and inserts institutional language; ensuring language consistent with protocol.
Enters and loads all required documents to OnCore and Complion.
Coordinates and validates the delegation log with the applicable DWG Clinical Research Manager.
Prepares and tracks/guides submission to IRB (CIRB, RSRB, Commercial IRB), FDA, ClinicalTrials.gov, etc.
Maintains regulatory records and necessary correspondence records.
Submits IRB approval letters and approved consent forms to sponsors as required to ensure studies remain active.
Prepares all protocol annual reviews, addenda, revisions, memos, safety reports, and consent form revisions for submission to the regulatory committees.
Assists with coordinating center functions as they relate to on-site and other site(s) participation in clinical trials and affiliate participation.
Prepares, submits, tracks, and responds to all regulatory (FDA and IRB) requirements, including safety and ongoing reporting for other participating site(s).
Prepares and submits progress reports and renewals to the IRB and sponsors.
Communication and liaison with study team, Sponsors and all stakeholders: Responsibilities include:
Liaises with Sponsor regarding activation requirements and timelines.
Liaises with other required stakeholders and committees (HURC, IBC, Cell lab/BMT Nurse Manager, Faculty, DWG, etc.).
Coordinates official internal activation.
Informs study coordinators and physicians when re-consents are required.
Liaises with Sponsor regarding maintenance of protocols.
Assists Clinical Research Coordinators and investigators with study document management and tracking.
Complies with Good Clinical Practice and the Code of Federal Regulations
Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines.
Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies.
Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
Maintains CITI and Conflict of Interest (COI) certification and renewal as required.
Gains knowledge in medical research terminology.
Continues to gain proficiency in UR-specific research software needed to manage clinical research protocols.
Assumes personal responsibility for keeping up with new developments in the field, related literature, and relevant clinical standards. Assists in helping others in same.
Participates in protocol-related training as required.
Other duties as assigned
Bachelor's Degree required or equivalent combination of education and experience. 1 year of clinical research or relevant work experience required or equivalent combination of education and experience. Fluent English language skills (oral and written) required. Preferred knowledge, skills and abilities: Ability to effectively manage a higher volume of protocols than the Regulatory Coordinator I; Ability to effectively manage moderately complex research protocols/procedures; Possesses a high degree of self-motivation; recognized ability to function independently; Proficient in managing multiple and competing priorities/demands; Detailed-oriented in record keeping and research documentation; Fully adheres to applicable safety and/or infection control standards; Understands and follows data integrity standards and processes; Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, OSHA guidelines, throughout study implementation; Strong interpersonal, communication (verbal and written), and organizational skills; Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients); Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet.
The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled
Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
Opening: Full Time 40 hours Grade 052 Cancer Center/Clin Trials Ofc
Schedule: 8:30 AM-5 PM