"OCRC Program Manager"

OCRC Program Manager

University of Colorado Anschutz Medical Campus
Department: Orthopedics

Job Title: OCRC Program Manager
Position #: 00845346 - Requisition 39018

Job Summary:

The primary focus area of this position is the management of the Orthopedics Clinical Research Core (OCRC). This includes direct oversight of Core team members and indirect leadership to other clinical research professionals throughout the Department. These roles will collaborate with Department research leadership to improve efficiency of clinical research management including study launch processes and ongoing operations, communication with and support of clinical research team members, regulatory oversight, and an improved pathway to success for clinical researchers.

The secondary responsibility of these positions is to serve as a central point of contact for Principal Investigators who utilize the OCRC. This may include managing regulatory submissions, ensuring compliance with applicable rules and regulations, serving as Department liaison with study sponsors and campus regulatory bodies, and completing other required activities and documentation pertaining to sponsored clinical studies.

Key Responsibilities:

• Collaborate with Department clinical research leadership to improve policies and procedures of the OCRC
• Help establish new Clinical Research Review Committee that will evaluate applications to utilize Core services and make selections based on pre-determined factors including feasibility and study coordinator time commitment
• Monitor workload and distribute among team members
• Serve as Department Point of Contact and Subject Matter Expert for clinical research, including answering questions related to compliance, regulatory submissions, and ongoing management of clinical trials
• Assist research professionals with compliance issues on an as-needed basis
• Stay apprised of regulatory changes related to clinical research and inform other clinical research professionals of key developments
• Offer mentorship to clinical research professionals throughout Department
• Onboard clinical research assistants
• Work with clinical research leadership to help ensure a high standard of compliance in all clinical research activities conducted by CU Orthopedics
• Develop and maintain a variety of reports and communicate and present data to stakeholders
• Collaborate with Research Services Program Director and Research Administrative Team on various projects including helping monitor study coordinator time/utilization and tracking effort as it relates to Departmental research pricing
• Ensure fiscal compliance with university policies and procedures
• Establish a structure of oversight and regular communication with each individual research program within Clinical Orthopedics
• Support Clinical Research Director with ad-hoc projects
• Recruit, supervise and manage research professionals across the Department
• Develop new processes to track clinical research metrics and create new reports for senior research leadership.
• Devise new strategies for improving various aspects of clinical research management, including but not limited to helping speed up study launch timelines, making more accurate feasibility assessments, better meeting enrollment targets, and improving clinical research communications/education across the Department.
• Create and implement processes to run the new Orthopedics Clinical Research Core; be responsible for daily operations of OCRC.
• Act as Lead Department Liaison in the event of internal and external audits.

Work Location:

Hybrid - this role is eligible for a hybrid schedule of 3 days per week on campus and as needed for in-person meetings.

Qualifications:

Minimum Qualifications

• Bachelor's degree in any field
  A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor's degree on a year for year basis.
• Four (4) years clinical research or related experience

Preferred Qualifications

• ACRP or SOCRA Certification
• Bachelor's degree in biology, physiology, kinesiology, engineering, or a related field
• Experience managing research teams and developing and implementing a variety of operational systems and training programs
• Five (5) years clinical research or related experience
• Prior experience providing program and/or project management duties in a clinical research setting
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
• Experience with navigation of external audits
• Experience with navigating CU Medicine/UCHealth research process, systems, and clinics
• Supervisory experience of multiple team members

Competencies, Knowledge, Skills, and Abilities

• Team-oriented with interest and experience in developing a team
• Detail-oriented with an ability to appreciate the big picture
• Skilled at organization and time management
• Effective oral and written communication skills to facilitate interactions across different programs and positions within Orthopedics
• Advanced knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
• Ability to establish and maintain effective working relationships with colleagues, researchers, sponsors, and study participants
• Strong project management skills and experience within a complex environment
• Highly flexible when priorities shift as Department develops a brand-new structure for supporting clinical research
• Excellent problem-solving skills with the ability to tactfully address any challenges
• Proficiency with Microsoft Office: Word, Excel, PowerPoint, Outlook, Teams
• Strong ability to work independently, multitask, and meet deadlines
• Commitment to the research mission of the Department of Orthopedics

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as $68,394-86,998.