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Senior Regulatory Professional

Company:
University of Colorado Anschutz Medical Campus
Job Location:
Aurora, Colorado
Category:
Laboratory and Research
Type:
Full-Time
Senior Regulatory Professional - 28492 University Staff

Description
University of Colorado Anschutz Medical Campus

Department: Obstetrics and Gynecology

Job Title: Senior Regulatory Professional

Position #: 00804735 – Requisition #: 28492
Job Summary:
 The Senior 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.

Key Responsibilities:
  • 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.
  • 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.
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.

The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, and holidays and more. To see what benefits are available, please visit: .
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, ethnic minorities, persons with disabilities, persons within the LGBTQ+ community, and all veterans. The University of Colorado is committed to diversity and equality in education and employment.
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,
Screening of Applications Begins:
 Applications will be accepted until finalists are identified, but preference will be given to complete applications received by February 28, 2023. Those who do not apply by this date may or may not be considered.
Anticipated Salary Range:
 The hiring range for this position has been established at $59,416 to $75,578 per year.

The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

This position is not eligible for overtime compensation.

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:
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 四虎影视 ADA Coordinator at ​.
Background Check Statement:
 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.
Vaccination Statement:
 The University of Colorado has a requirement for COVID-19 vaccinations and full completion thereof by 9/1/21 or upon start date. Information regarding this requirement, and exemptions can be found at:

Anschutz:

Unit-Specific Exemptions:
  • Anschutz Campus – Accommodations may be granted for medical or religious reasons.
The University of Colorado 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.

Qualifications
Qualifications:
 Minimum Qualifications:
  • Bachelor's degree in any field.
    • Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
  • At least two (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 四虎影视, 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.
Application Materials Required: Cover Letter, Resume/CV, List of References

Job Category: Research Services

Primary Location: Aurora Department: U0001 -- DENVER & ANSCHUTZ MED CAMPUS - 21608 - SOM-OB/GYN GONC GENERAL OPS

Schedule: Full-time

Posting Date: Mar 6, 2023

Unposting Date: Ongoing Posting Contact Name: MMatthew Bishop Posting Contact Email: Position Number: 00804735

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