CReST Operations Manager

University of Colorado•Colorado Springs, CO

2d•$77,736 - $104,166•Hybrid

About The Position

The Clinical Research Support Team (CReST) is part of the Office of Clinical Trials and provides institutional support to clinical investigators studying a multitude of indications in over 30 departments across the Anschutz Medical Campus. CReST supports clinical investigators for all activities related to the successful conduct of clinical research, from study start-up through close out. This is the cornerstone to translate basic science knowledge into clinically useful treatment for patients. This role will oversee CReST staff working on studies in multiple indications, such as Radiology, Oncology, Endocrinology and multiple others, and ensure that these studies are conducted according to regulatory requirements, Good Clinical Practice, and applicable University and Sponsor policies. The CReST Operations Manager is responsible for managing a team of research coordinators and other staff (e.g., regulatory staff, junior managers) responsible for study coordination, regulatory tasks and data collection/entry; and is responsible for logistical support for office management and operations, study startup (including budget negotiation), performance review, hiring, and staff assignments. The Operations Manager will have independent decision making and leadership responsibilities, including operational strategic planning.

Requirements

A bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution.
Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis.
5 years clinical research experience
2 years supervisory experience
Experience with Industry and Investigator-initiated clinical trials
ACRP or SOCRA certification, must be obtained within 6 months of hire
Applicants must meet minimum qualifications at the time of hire.
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.
Ability to interpret and master complex research protocol information
Working knowledge of clinical trial regulations and Good Clinical Practice
Technical/Procedural writing
Superior organizational and time management skills
Familiarity with RedCap and EPIC
Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint)
Knowledge of study start-up

Nice To Haves

Experience submitting to local and central IRBs
Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification
Experience with research budget and grant development for sponsored projects
Experience with Industry and Investigator-initiated clinical trials
Experience with NIH-sponsored and industry clinical research studies, including multi-center clinical trials

Responsibilities

Communicates with and relays timely information to sponsor, investigators, study staff, and CReST Team Members
Responsible for development of onboarding and training of all project managers and providing high-level oversight of training programs for all coordinator staff.
Provides oversight of processes, studies, and employees
Direct supervisory duties of project managers and/or senior staff, including directing the day-to-day work, coaching and mentoring, annual performance reviews and other management activities as needed.
Provides general oversight of the coordination and regulatory/administrative services related to specific studies contracted with CReST
Oversees study start-up and regulatory processes as a backup to the CReST managers and coordinators
Provides backup to project managers and coordinators related to study-specific tasks, as needed.
Liaises with study teams and sponsors as needed to facilitate efficient and compliant study operations.
Provides backup to project managers and coordinators for regulatory submissions to local and central IRBs, FDA, and other regulatory agencies.
Acts as primary contact for study sponsor representatives and study subjects for research studies
Provides backup support for study budget development and negotiation.
Performs or directs invoicing and invoice payment reconciliation.
Performs or directs processes related to study subject payments.
Monitors coordinator billable time and answers coordinator questions related to time tracking.
Develops operational policies and procedures to standardize the responsibilities and communication to ensure operational compliance with Food and Drug Administration, National Institutes of Health and other federal, state, and institutional guidelines.
Assures adherence to all research standards by CReST coordinators as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), and other pertinent regulatory agencies.
Collaborates with key stakeholders to ensure harmonious policy development and operations related to trial conduct and compliance across various teams (e.g., CCTO, OCRST, CU Innovations, CRAO)
Works in conjunction with CReST and OCT leadership on the development and reporting of CReST financial data and annual cost study.
Completes or assists in the completion of monthly billing for CReST services and in maintaining functionality and training related to billing/time tracking tools.
Oversees or takes direct responsibility for budget development, negotiation, invoicing, invoice payment reconciliation and other clinical trial finance tasks
Assists CReST Leadership in the development and tracking of Key Performance Indicators and other essential metrics (e.g., startup time, billable hours, task types, customer characteristics)
Initiates and directs special projects as needed related to CReST services, procedures, continuous improvement, and the needs of the CU research community.
Assists CReST Leadership in career and organizational pathway development and planning.
Cultivates relationships and connections with key stakeholders across the CU research community.
Directly supervises CReST staff, including managers and/or other senior coordinator or regulatory staff as needed.
Provides coaching, mentoring to all staff and mediation and corrective interventions as needed
Facilitates the hiring process for new project managers or other senior staff, including pre-screening interviews, scheduling group interviews, and reference checks. Serves as the Search Committee Chair, as needed.
Serves as hiring manager for positions, as needed.
Anticipates staffing needs and communicates with CReST Leadership and central HR to post and hire for positions.
Oversees all HR processes for all direct reports including approving monthly timesheets, approving any sick time and vacation requests, and conducting annual performance reviews.
Oversees and manages office operations, including submitting work orders, ordering office supplies, and providing CReST leadership with key information related to office operations.
Independent decision making and strategic thinking
Other duties as assigned by Assistant Director