Description

Department:

85296 Wake Forest University Health Sciences - WF Clinical Trial Methods Center of Excellence

Status:

Full time

Benefits Eligible:

Yes

Hours Per Week:

40

Schedule Details/Additional Information:

Regular Daytime Hours, Travel to regional sites required

JOB SUMMARY

The National Center for Clinical Trials (NCCT) is designed to serve as an innovative platform to revolutionize and catalyze the conduct of clinical trials-greatly accelerating the translation of scientific findings into improvements in the prevention, diagnosis, and treatment of disease for our communities and patients. The NCCT will offer core services for patient recruitment and enrollment, trial administration and follow-up, and to gather real world data and evidence. The Clinical Trial Methods Center (CTMC) has been established within the Wake Forest University School of Medicine to provide the necessary tools and expertise that the NCCT will access and apply to deliver many of its core services.

This position will be primarily responsible for assessing and reviewing clinical trial sites across a region to ensure general readiness to conduct clinical trials and readiness to conduct specific clinical trials as they are presented. These responsibilities include evaluating and facilitating the development of site expertise and engagement, space to conduct trials, staff training, technology platforms and access, services available at sites to support trials, performance in conducting trials, etc. This position will also be responsible for working with NCCT and site leadership to develop capacity at sites through personnel and equipment purchases as necessary. In addition, this position will be responsible for assessing site readiness to conduct specific trials as needed. This position will work with business development and study coordination teams to streamline communications between all functional groups and facilitate research.

The role also involves coordinating with site leadership and research staff to address any issues that may arise and providing ongoing support to maintain the highest standards of trial conduct. Effective communication and collaboration with various stakeholders are essential to ensure the successful execution of clinical trials.

This position is a hybrid position that requires frequent travel to sites across a specific region (either 1) Wisconsin and Illinois, or 2) North Carolina, South Carolina and Georgia) for evaluation, assessment and relationship building.

EDUCATION/EXPERIENCE

Master's degree in a relevant discipline such as Health Administration, Nursing, Business, or Basic Science with three years of relevant management experience; or, an equivalent combination of education and experience. Significant experience in managing clinical trial teams at a service line, therapeutic area or at a site level.

ESSENTIAL FUNCTIONS

I. General Site Readiness Assessment

• Develops and maintains site readiness checklists and SOPs
• Tracks and reports site gaps
• Primary points of research-related contact for each site/service line/therapeutic area.
• Staffing levels and roles (e.g., PI, Sub-Is, CRCs, regulatory coordinators, lab techs, pharmacists)
• PI trial experience, expertise and enrollment performance
• Experience and training of site personnel related to NCCT SOPs (Including gaps in staffing, training, or certifications.)
• Facilities and space to conduct and monitor trials
  • Conduct physical walk-throughs of clinical space (exam rooms, infusion chairs, storage areas, etc.) and ancillary service areas.
• Equipment & Storage (including calibration processes and maintenance logs, alarms, etc.)
• Ancillary Services Capabilities
  • Pharmacy, lab, imaging, etc. (including site-specific SOPs for scheduling, procurement, storage tracking, etc.)
  • Diagnostic Services
• Technology Assessment
  • Confirm access to technology platforms (eg, EHR, EDC, etc.)

II. Per-Trial Readiness Assessment

• Work with site leadership and NCCT Central Trial Services Platform (CTSP) staff to assess site capability for protocol requirements.
• Investigator & Staff Suitability

• Confirm staff qualifications and availability
• Evaluate CRC bandwidth and PI engagement
  • Perform onsite assessments as needed per protocol to confirm resources and staffing for specific trials.
  • Trial-Specific Infrastructure Needs
• Identify trial-specific gaps (e.g., imaging, -80°C freezer, etc.)
• Coordinate equipment purchases or rentals in conjunction with Business Development and Site Engagement Directors
  • Work with central clinical research coordinator pool and/or third party to deploy study staff as needed per site/trial.
  • Attend Site Qualification Visits and Site Initiation Visits as required.

III. Strategic Infrastructure Development

• Investment Planning & Execution

• Provides input to Business Development on business plans for new hires or equipment
• Oversees procurement and infrastructure implementation
• Works with Site Engagement Director and Business Development team to facilitate planning for site expansion and future trials

IV. Reporting

• Evaluate and document site readiness criteria in central site resource database every 6 months
• Report on site needs, readiness, and escalation points to NCCT leadership
• Communicate regularly with site leadership on resource needs

V. Performs other related duties incidental to the work described herein.

SKILLS/QUALIFICATIONS

Excellent verbal and written communication skills. Ability to work independently to develop processes. Ability to travel to affiliate sites and central offices as needed. Familiar with institutional/governmental regulations and guidelines related to clinical research including the elements of Good Clinical Practices.

• Evaluate CRC bandwidth and PI engagement
  • Perform onsite assessments as needed per protocol to confirm resources and staffing for specific trials.
  • Trial-Specific Infrastructure Needs
• Identify trial-specific gaps (e.g., imaging, -80°C freezer, etc.)
• Coordinate equipment purchases or rentals in conjunction with Business Development and Site Engagement Directors
  • Work with central clinical research coordinator pool and/or third party to deploy study staff as needed per site/trial.
  • Attend Site Qualification Visits and Site Initiation Visits as required.

III. Strategic Infrastructure Development

• Investment Planning & Execution

• Provides input to Business Development on business plans for new hires or equipment
• Oversees procurement and infrastructure implementation
• Works with Site Engagement Director and Business Development team to facilitate planning for site expansion and future trials

IV. Reporting

• Evaluate and document site readiness criteria in central site resource database every 6 months
• Report on site needs, readiness, and escalation points to NCCT leadership
• Communicate regularly with site leadership on resource needs

V. Performs other related duties incidental to the work described herein.

SKILLS/QUALIFICATIONS

Excellent verbal and written communication skills. Ability to work independently to develop processes. Ability to travel to affiliate sites and central offices as needed. Familiar with institutional/governmental regulations and guidelines related to clinical research including the elements of Good Clinical Practices.

Pay Range
$43.30 - $64.95

Our Commitment to You:

Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more - so you can live fully at and away from work, including:

Compensation

• Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training
• Premium pay such as shift, on call, and more based on a teammate's job
• Incentive pay for select positions
• Opportunity for annual increases based on performance

Benefits and more

• Paid Time Off programs
• Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
• Flexible Spending Accounts for eligible health care and dependent care expenses
• Family benefits such as adoption assistance and paid parental leave
• Defined contribution retirement plans with employer match and other financial wellness programs
• Educational Assistance Program

About Advocate Health

Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation's largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.

Under administrative review, provides overall administrative direction and coordination for policies, procedures, and programs for a large number of research studies and/or clinical trials. Supervises and provides expertise and guidance to staff regarding IRB submissions, communication, and implementation of HIPAA regulations, compliance and other regulatory issues. Requires the use of judgment and discretion in performing the assigned duties and responsibilities.