Senior Regulatory Professional

Job Summary:

This Regulatory Professional will be responsible for providing regulatory management and oversight for clinical trials. Specific duties may include writing accurate informed consent forms, submissions to applicable review committees (PRMS, IRB of record, UCHealth Research Administration), completion of regulatory documents (Form 1572, Financial Disclosure forms), protocol amendment submissions and semi-annual or annual IRB continuing reviews. This position is also responsible for knowledge of Unanticipated Problem reporting in order to guide clinical colleagues in their submission requirements. In order to succeed in this position, this detail-oriented individual must be able to demonstrate superior organizational skills in order to successfully track multiple tasks occurring in parallel. This incumbent must be self-motivated in order to complete tasks quickly and within set deadlines. 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 so superior communication skills (oral and written) are required. The position may be utilized to support research at the main Anschutz Medical Campus as well as in Northern Colorado. The professional in this position will not be called on to make independent medical decisions at any time, but a solid fundamental knowledge of biological and medical sciences is necessary for this position. Additionally, an appreciation of accepted methods of clinical research is highly desirable.

Supervision Received: Position will report to Dr. Bradley Corr, position #0000778

Supervision Exercised: This position will have no Supervisory Responsibilities

Duties:

95% - Research/Regulatory Duties

• Serves as regulatory contact person for ongoing clinical research studies and meets with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of regulatory records.
• Writes clear and accurate consent/ HIPAA documents.
• Completes consents, applications, and other required forms as per the applicable Institutional Review Board (IRB).
• Submits, tracks and processes protocol amendments for National Clinical Trials Network (NCTN) studies within the required 30-day period (for CIRB).
• Submits complete and accurate clinical research applications to all required regulatory bodies for the conduct of clinical research at the University of Colorado Cancer Center. This may include, but is not limited to, the following:
  
  
  
  • Colorado Multiple Institutional Review Board (COMIRB)
  • Western Institutional Review Board (WIRB)
  • NCI Central Institutional Review Board (CIRB)
  • Protocol Review and Monitoring System (PRMS)
  • Hospital Research Support Services (UCH-RSS)
  • University of Colorado Hospital Clinical Trials Office (CTO)
  • Completes and submits continuing reviews, amendments, and other protocol-specific documents.
  
  
  
  
• Completes and submits accurate federal forms, consents, HIPAA Authorizations, and obtains required approvals specific to the Denver VA medical Center.
• Navigates applicable NCTN websites. This may include Clinical Trials Support Unit (CTSU), Southwest Oncology Group (SWOG) and NRG Oncology (NSABP, RTOG, GOG).
• Updates OnCore with regulatory documents and dates.
• Assists in the completion of initial Institutional Biosafety (IBC) applications.
• Provides shadowing of daily tasks for new members of the Regulatory Affairs team.
• Assists in document collection and site regulatory communication for multi-center clinical trials.
• Potentially meets with representatives from Food and Drug Administration (FDA) for review of records.
• Completes required documents for all submissions specific to trials requiring Institutional Biosafety Committee (IBC) oversight.
• Completes required documents for all submissions specific to trials requiring FDA approval.
• Assists with training for new members of the Regulatory Affairs team.
• Collects documents and site regulatory communication for multi-center clinical trials.
• Understanding of research standards as set forth by FDA, OHRP, UCH, UCD and NCI.
• Adhere to research regulatory standards
  
  
  
  • Assures compliance with all protocol details which includes ensuring the capture of all data points requested on a protocol-specific basis and ensuring that tests and procedures required by clinical protocols are performed and documented
  
  
  
  
• Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelines
• Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies
• Assist and train junior team members
  
  
  
  • Arranges orientation and provides training and leadership to the clinical research staff.
  
  
  
  
• Assist with developing or develops protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies
• Assist with identifying issues related to operational efficiency and shares results with leadership
  
  
  
  • Assists clinical research staff with technical issues, problem solving and intervention when appropriate; delegates responsibility for elements of the conduct of selected clinical trials.
  • Makes recommendations regarding clinical research personnel issues, including performance evaluations, counseling, and disciplinary actions with guidance from the Director of Clinical Research.
  
  
  
  
• Collect information to determine feasibility, recruitment, and retention strategies. Employ, evaluate, and assist with the implementation of innovative solutions to maximize recruitment and retention
• Serve as a resource and participate in study initiation and close out duties
• Assist with the day-to-day operations of clinical trials and studies when needed
• Fill in for team PRA/CRC to complete day to day patient focused research activities when necessary, including but not limited to:
  
  
  
  • Obtains study subject medical history and current medication information, reviews research protocol Inclusion/Exclusion Criteria, and confirms eligibility of subject to participate in clinical trial.
  • Performs informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required
  • Interviews prospective subjects for a variety of research clinical trials. Educates potential subjects on the details of the studies through phone contacts and personal interviews
  • Schedules subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
  • Collaborates with hospital staff to ensure tests and procedures, required by research protocols are performed and documented (e.g., vital signs, phlebotomy, specimen processing, electrocardiograms (EKGs), research drug administration, and protocol-specific tests and procedures)
  • Research specimen collection, processing and shipping, develops protocol-specific source documents (e.g., data collection tools, study visit checklists, pharmacokinetic sample collection worksheets, etc.)
  • Reports subject Adverse Events (AEs) and Serious Adverse Events (SAEs) to appropriate parties (e.g., Principal Investigator, Study Sponsor, Food and Drug Administration (FDA), Data and Safety Monitoring Committee (DSMC), Regulatory Affairs Coordinator, etc.)
  • Familiar with protocol and all study documents and reviews documents after each study subject visit for completeness and accuracy
  
  
  
  

5% - Administrative and Operational Duties & Responsibilities

• Plans and directs investigator and coordinator meetings including but not limited to pre-study qualification visits, initial orientations, study audits, and closeout visits.
• Work with finance team members to resolve discrepancies and to review account balances on a regular basis.
• Participate in external audits and internal process improvement strategies to promote consistent best practices.
• Acts as support and able to fill in for team PRA/CRC role when necessary.

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.

Work Location:

Hybrid - this role is eligible for a hybrid schedule of # days per week on campus and as needed for in-person meetings to be determined by Supervisor.

Why Join Us:

Medical research is the engine that drives CU Gynecologic Oncology as we conduct more clinical trials and research than any other gynecologic oncology practice in the state of Colorado. Our research faculty focus on clinical, translational, and basic science approaches to finding novel treatments for gynecological cancers. Clinical trials and research efforts result in innovative care and more effective treatment for some of the most complex medical cases, as well as for more common gynecologic oncology conditions. The Gynecologic Oncology Division conducts an array of home-grown clinical trials designed and implemented by providers within our division. The Senior Regulatory Professional will help the Division of Gynecologic Oncology to expand our research team to accommodate the growing number of clinical trials within the division.

Why work for the University?

We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:

• 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

There are many additional perks & programs with the CU Advantage.

Diversity and Equity:

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.

Qualifications:

Minimum Qualifications:

• Bachelor's degree in any field
• 2 years of regulatory compliance experience

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Bachelor's degree in science or health related field.
• Two (2) years clinical research or related experience.
• One (1) year of oncology research experience.
• Personnel management experience.
• Experience teaching, orienting, and mentoring new employees to clinical research.
• Experience assisting in the development of policy, procedure or patient education materials related to clinical research.
• One of the below:
  
  
  
  • CCRC - Certified Clinical Research Coordinator
  • CCRP - Certified Clinical Research Professional
  • CCRA - Certified Clinical Research Associate
  
  
  
  

Knowledge, Skills and Abilities:

• Knowledge and understanding of federal regulations, Good Clinical Practice (GCP), and IRB requirements.
• Ability to communicate effectively, both in writing and orally.
• 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.
• Knowledge of basic human anatomy, physiology medical terminology.
• Ability to interpret and master complex research protocol information.
• Knowledge of basic human anatomy, physiology, medical terminology.
• Advanced knowledge of GCP, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials, and NCI common toxicity definitions.
• Excellent interpersonal and customer service skills.
• Excellent oral and written communication skills.
• Organization and time management skills.
• Leadership abilities.

Understands the phases and concepts of clinical trials and the overall philosophies of conducting cooperative group research as they differ with National Cancer Institute (NCI) sponsored, private industry and investigator initiated clinical trials.

How to Apply:

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

2. Curriculum vitae / Resume

3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address

Questions should be directed to: Matthew Bishop, Matthew.Bishop@cuanschutz.edu

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by Feb 28^th, 2025. Those who do not apply by this date may or may not be considered.

Anticipated Pay Range:

The starting salary range for this position has been established as: $59,996-$76,314

The above salary 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

ADA Statement:

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.

Background Check Statement:

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.

Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. 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.