**Research Services Manager** **Description** **University of Colorado Anschutz Medical Campus** **Department: Surgery** **Job Title: Research Services Manager** **Position #: 00765239 - Requisition #:35780** **Job Summary:** **Nature of Work** **Some Assignments will not move beyond this level.** **Position Emphasis:** **Key Responsibilities:** **Management Duties 20%** + Recruit, onboard/train, supervise and lead a team of 5 Research Services team members. + Arrange and provide Regulatory Management training for all to Clinical Research Team Leads in the Department of Surgery + Financial management of the closeout process for all clinical trials under the purview of this position. + This includes review and confirmation that all invoiceable items have been paid, review of coordinator hours charged to the trial, etc. + In partnership with the DOS Post-Award team, ensure completion of financial transactions for all clinical trials under the purview of this position. + This includes invoiceable items such as study startup fees, regulatory fees, monitoring visits, subject visits, etc. + Verify accurate submission of all regulatory documents to appropriate parties and the timelines thereof. + Assist staff with technical issues, problem solving and intervention. **Clinical Research/Regulatory Duties 80%** + Serve as the primary point of contact for all regulatory inquiries and submissions + Audit compliance on a regular basis and take corrective action when necessary + Understand and keep abreast of all relevant regulatory requirements, including but not limited to FDA, EMA, ICH, GCP, and GLP guidelines + Oversee compliance for all clinical trials in the department. There are over 200 clinical trials and internal projects running concurrently at any given time + Ensure creation and maintenance records of all regulatory compliance activities across the department + Provide guidance on regulatory procedures to Team Leads and other employees who will be involved in compliance activities + Review internal policies and procedures to ensure that they are consistent with regulatory requirements + Develop and update compliance policies and procedures to ensure that the department is in full compliance with all laws and regulations + Serve as the final approver on all HIPAA documents and final reviewer on all clinical research applications before they are submitted to required regulatory bodies. This may include, but is not limited to, the following: + Colorado Multiple Institutional Review Board (COMIRB) + Western Copernicus Group Institutional Review Board (WCG IRB) + Advarra Institutional Review Board + Scientific Advisory and Review Committee (SARC) + Protocol Review and Monitoring System (PRMS) + Research Administration (RA) + Oversee and approve all IRB submissions, before they are moved forward to regulatory bodies + Manage human research subject recruitment and ensure compliance with all applicable regulatory agencies/policies; oversee subject enrollment and onboarding. + Oversee all research data received from Industry, RedCap and Oncore; review, analyze and disseminate all data + Monitor adverse events and take appropriate action when necessary + Keep abreast of new technologies and how they can be used to improve regulatory compliance. + Manage regulatory compliance throughout lifecycle of study, from inception to completion. + Manage all IRB communications and communications about related regulatory matters relevant to Department of Surgery compliance program; selects, reviews, composes, and disseminates as appropriate in order to achieve highest level of compliance. + Update SOPs as regulations change to ensure the regulatory and compliance program is on track + Serve as the primary liaison with federal regulatory agencies, including but not limited to the FDA, Department of Defense (DoD), and Office of Human Research Protections (OHRP). + This includes preparation and submission of Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications to the U.S. Food & Drug Administration (FDA). + Submit Adverse Event Reports and Protocol Deviations according to institutional review board and sponsor-specific reporting requirements. + Ensure timely update of Oncore for all trials in assigned divisions. + Work closely with the Clinical Research Manager to develop and maintain internal systems utilizing continuous improvement (CI) tools that optimize workflows for regulatory and research programs. + Assists Clinical Research Manager with resolving issues by utilizing independent judgement, discretion, creativity and analytical thinking **Why Join Us:** **Why work for the University?** + Medical: Multiple plan options + Dental: Multiple plan options + Additional Insurance: Disability, Life, Vision + Retirement 401(a) Plan: Employer contributes 10% of your gross pay + Paid Time Off: Accruals over the year + Vacation Days: 22/year (maximum accrual 352 hours) + Sick Days: 15/year (unlimited maximum accrual) + Holiday Days: 10/year + Tuition Benefit: Employees have access to this benefit on all CU campuses + ECO Pass: Reduced rate RTD Bus and light rail service **Diversity and Equity:** **Qualifications:** **Minimum Qualifications:** + A bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, Biology, or a directly related field from an accredited institution. + Five (5) years of research, research administration, research benchmark, clinical trial, or experience in a related field. + A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis. **Preferred Qualifications:** + Three (3) or more years of experience working with clinical trials. + Experience with grant management + Regulatory compliance experience in an academic medical center **Knowledge, Skills and Abilities:** + A strong working knowledge of Good Clinical Practices (GCP), U.S. Food and Drug Administration (FDA) rules and regulations in relation to clinical trials, National Institutes of Health (NIH) guidelines, International Council for Harmonisation (ICH) guidelines, Health Insurance Portability and Accountability Act (HIPAA) regulations in relation to clinical trials, and other universally accepted practices and procedures within clinician trial management. + Skilled in professional and prompt communication + Ability to establish and maintain effective working relationships with employees at all levels throughout the institution. + Outstanding customer service skills. + Demonstrated commitment and leadership ability to advance diversity and inclusion. + Ability to manage multiple tasks and keep organized. + Ability to work well with outside entities and follow state rules. + Ability to lead teams + Ability to problem solve + Outstanding organizational skills **How to Apply:** **Screening of Applications Begins:** th **Anticipated Pay Range:** **ADA Statement:** **Background Check Statement:** **Vaccination Statement:** **Job Category** **Primary Location** **Schedule** **Posting Date** **Unposting Date** **To apply, visit https://cu.taleo.net/careersection/2/jobdetail.ftl?job=35780&lang=en (https://apptrkr.com/5887462)** Copyright 2024 Jobelephant.com Inc. All rights reserved. Posted by the FREE value-added recruitment advertising agency (https://www.jobelephant.com/) Research Services Manager - 35780 University Staff Clinical Science Managers perform clinical research related functions which may include patient-oriented research or research conducted with human subjects. Patient-oriented research includes mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. Clinical Science Managers may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research. Clinical Science Managers independently manage clinical research programs, perform clinical research project management functions and supervise clinical research teams of 3 or more FTE. The Manager is responsible for the management, development, implementation and oversight of the clinical research operations and functions in the assigned unit. The manager also provides policy guidance and interpretation to the team and other stakeholders on a wide variety of personnel and operational issues assuring compliance with Federal, University, and departmental rules and regulations. This position will be responsible for supervising a team of 5 Research Services staff in addition to providing regulatory management and oversight for clinical trials for the Department of Surgery. Specific duties may include writing accurate informed consent forms, submissions to applicable review committees, completion of Regulatory documents, protocol amendment submissions and semi-annual or annual IRB continuing reviews. The role will also be responsible for knowledge of Unanticipated Problem reporting in order to guide clinical colleagues in their submission requirements. This position serves as the main point of contact regarding regulatory matters for ongoing clinical research studies and meets with representatives from sponsoring industrial partners or DOS staff for initial orientation to studies and for review of regulatory records. The Research Services Manager is responsible for ensuring that the department and individuals abide by all documented regulations. They are tasked with developing new regulations or policies related to their area of focus. This position is the hub' of communication between external (review committee coordinators, review committee members, study monitors) and internal (clinical study staff, investigators, clinical managers) contacts. This position will also serve as the regulatory SME for the Clinical Research Office. Join the University of Colorado's Department of Surgery, a hub of surgical excellence and groundbreaking research. Our team of distinguished surgeons and researchers is renowned for their contributions both nationally and internationally, pushing the boundaries of medicine through innovation, cutting-edge devices, and advanced procedures. With top-tier NIH funding and a relentless pursuit of new treatments and technologies, we are dedicated to enhancing patient outcomes. Be part of a dynamic environment where your work makes a meaningful impact on lives every dayWe have AMAZING benefits and offerexceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including: There are many additional perks & programs with the CU Advantage (https://apptrkr.com/get\_redirect.php?id=5887462&targetURL=https://advantage.cu.edu/) . The University of Colorado 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, ethnically minoritized individuals, persons with disabilities, persons within the LGBTQ+ community and all veterans. In addition, the Anschutz Campus has also been recognized as an Age-Friendly University. The University of Colorado is committed to diversity and equality in education and employment. Applicants must meet minimum qualifications at the time of hire. For full consideration, please submit the following document(s):1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position (only use if a cover letter is necessary)2. Curriculum vitae / Resume3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email addressQuestions should be directed to: Tracey MacDermott, tracey.macdermott@cuanschutz.edu (https://apptrkr.com/get\_redirect.php?id=5887462&targetURL=tracey.macdermott@cuanschutz.edu) Immediately and continues until position is filled. For best consideration, apply by Monday, December 30, 2024. The starting salary range (or hiring range) for this position has been established as $70,211 - $89,309The 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. This position may be eligible for overtime compensation, depending on the level.Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.Total Compensation Calculator: http://www.cu.edu/node/153125 (https://apptrkr.com/get\_redirect.php?id=5887462&targetURL=http://www.cu.edu/node/153125) 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 hr.adacoordinator@cuanschutz.edu (https://apptrkr.com/get\_redirect.php?id=5887462&targetURL=hr.adacoordinator@cuanschutz.edu) . The University of Colorado 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. CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases (https://apptrkr.com/get\_redirect.php?id=5887462&targetURL=https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf) . If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program (https://apptrkr.com/get\_redirect.php?id=5887462&targetURL=https://research.cuanschutz.edu/ehs/home/divisions/occupational-health/oh-enrollment) . Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Aurora Department: U0001 -- Anschutz Med Campus or Denver - 20306 - SOM-SRG-CH GENERAL OPERATIONS : Full-time : Dec 19, 2024 : Ongoing Posting Contact Name: Tracey MacDermott Posting Contact Email: tracey.macdermott@cuanschutz.edu (https://apptrkr.com/get\_redirect.php?id=5887462&targetURL=tracey.macdermott@cuanschutz.edu) Position Number: 00765239jeid-d2a645418a9f774f8a8dca0e136b48a1 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.