University of Colorado Lead Regulatory Coordinator in Aurora, Colorado
University of Colorado | Anschutz Medical Campus
School of Medicine, Department of Obstetrics and Gynecology
Lead Regulatory Research Coordinator (Research Services Principal Professional)
Position #00762938– Requisition #19809
* Applications are accepted electronically ONLY at www.cu.edu/cu-careers
- The University of Colorado Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.
Department of Obstetrics and Gynecology has an opening for a full-time University Staff (unclassified) Lead Regulatory Research Coordinator position.
The University of Colorado Anschutz Medical Campus is a public education, clinical and research facility serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges, and receives over $500 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care. Read CU Anschutz Quick Facts here. at https://www.cuanschutz.edu/docs/librariesprovider15/default-document-library/2019-facts-brochure_web.pdf
Nature of Work:
As a vital team member of the Administrative Research Core, the Lead Regulatory Research Coordinator is part of a collaborative team and is responsible for assisting the Ob-Gyn faculty with planning, organizing, and managing operational activities related to clinical research protocols, including Institutional Review Board (IRB) submissions and the Office of Grants and Contracts (OGC) routing process. This position will be responsible for ensuring departmental compliance with diverse federal, state, and university regulations, policies, and procedures governing Ob-Gyn clinical research efforts.
Supervision Received : This position reports to the Research Program Manager.
Supervision Exercised: This position will include the management of clinical research projects and will have authority to make business decisions as they relate to the administration of these functions. The position will provide leadership support for all research regulatory activities needed by the department. This position will supervise a minimum of 1 regulatory coordinator FTEs, with the potential for the team to grow as the clinical research portfolio of the department grows.
Examples of Work Performed:
Position will be responsible for providing supervision to regulatory staff and leadership to PI designated personnel for all regulatory submissions for Ob-Gyn investigators, as well as regulatory compliance of research activities within the department.
Responsible for independently advising on and generating complete and accurate clinical research applications to all required regulatory bodies for the conduct of clinical research at the University of Colorado, including:
The Colorado Multiple Institutional Review Board (COMIRB)
Scientific Advisory & Review Committee (SARC)
Protocol Review and Monitoring System (PRMS)
Human Subjects Research Portal (HSR)
Clinical and Translational Research Centers (CTRC) and Clinical Trials Office (CTO)
UCH Research Support Services (RSS)
Denver Health Sponsored Research Office (SPARO)
Children’s Hospital Colorado (CHCO)
National Institutes of Health (NIH)
Children’s Research Institute (RI)
US Food and Drug Administration (FDA)
Various industry sponsors or other institutional entities as required by the research projects
Develops (or provides oversight of the development of) clear and accurate subject informed consent documents and HIPAA authorization documents for investigators.
Routes DUAs, MTAs, BAAs, and other clinical agreements for full execution and monitors progress following up as needed.
Serves as OnCore trainer and "super user" for Ob-Gyn.
Maintains a comprehensive record keeping system of clinical research data and reports metrics of productivity on a monthly basis to Department research leadership.
Maintains regulatory document e-files for each clinical research protocol.
Conducts quality assurance reviews of research participant and study files and advises on best practices relating to clinical research.
Serves as regulatory liaison between Ob-Gyn researchers and University committees involved in the review and approval of research projects.
Industry Sponsored Pre-and Post Award:
Responsible, in coordination with the ARC financial team for the development of clinical budgets for industry-sponsored clinical trials/studies.
Develops and maintains a comprehensive start-up fee breakdown for industry-sponsored trials.
Reviews and interprets relevant federal, state, local, and university rules, regulations, and guidelines and communicates these to Ob-Gyn investigators and research assistants.
Routes to OGC for budget review and coordinates HSR portal submission.
Oversees contract reviews to full execution.
Communicates with sponsors, investigators, and study teams for budget negotiations.
Collaborates with PI and study team to prepare and submit invoices, including tracking invoices sent and payments received according to the project requirements.
Along with ARC Finance team, responsible for updates and financial projections to PIs on a monthly basis, processing JEs and PETs as needed for account management and project clean-up
Reviews payroll on industry sponsored projects is accurate with PIs.
Performs final reviews for study closeouts.
Provides direct supervision to regulatory coordinator staff, responsible for performance management, training, performance evaluations, professional coaching, and maintenance of appropriate personnel records
Responsible for understanding and complying with pertinent policies issued by the University of Colorado, the State of Colorado, and federal authorities
Develops and presents educational content to department research faculty, staff, and professional research assistants at quarterly research meetings, faculty meetings, and other relevant meetings as necessary.
Develops original content for department research edition newsletter, including advising research personnel on changing regulations and policies/procedures.
Assists the research services manager with developing general research policies and procedures relating to clinical research and is independently responsible for development and maintenance of department SOPs relating to regulatory policies and procedures.
Cross-trains with the other members of the team and provides service coverage when needed.
Identifies and participates in training opportunity to enhance knowledge in all areas of responsibilities.
Other duties as assigned.
Salary and Benefits:
The salary range ( or hiring range ) for this position has been established at $6,2593 - $70,000
The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty and training.
The above salary range ( or hiring range ) represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting.
Total Compensation Calculator: https://www.cu.edu/employee-services/total-compensation
Diversity and Equity:
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at email@example.com.
The University of Colorado Denver | Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.
The University of Colorado Denver | Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.
A bachelor’s degree in public health, public administration, social/behavioral health, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution
Experience working in an academic research environment.
3 years of experience with clinical research coordination.
Required: Candidate must meet minimum qualifcations at time of hire.
Experience working with academic Institutional Review Board or the conduct of FDA-regulated clinical trials.
Experience with Oncore, InfoEd, CU Data, Marketplace, etc.
Experience communicating with Industry Sponsors.
Experience with clinical research budgeting.
Certified Clinical Research Professional (CCRP).
Competencies/Knowledge, Skills and Abilities:
Demonstrated ability to work effectively with a diverse population of faculty, staff and students.
Excellent knowledge regarding clinical research regulations and principals of ethical conduct.
Knowledge, experience, and ability to manage complex information and computer systems.
Effective communication/presentation skills and a proven track record of forming collaborative and effective working relationships with physicians and administrative leaders.
Demonstrated commitment and leadership ability to advance diversity, equity, and inclusion.
This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.
Job: Research Services
Primary Location: Aurora
Job Category Research Services
Department U0001 -- DENVER & ANSCHUTZ MED CAMPUS
Posting Date Jan 19, 2021
Unposting Date Ongoing
Posting Contact Name Pam Alvarez-Moran
Posting Contact Email Pamela.Alvarezmoran@cuanschutz.edu
Posting Number 00726938
Req ID: 19809
The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.