Director - Pre-Award, Office of Clinical Research

The Wake Forest University School of Medicine (WFUSM) and Advocate Health enterprise is a top 50 national academic medical center and world class health system with an extramurally funded research portfolio of over $400M annually. We bring together high quality health care with innovative research as an academic learning health system with the goal of improving the health of our patients and communities we serve.

The department of Research Administration is a unified research entity comprised of over 300 teammates structured to provide outstanding research administration support in all research domains (e.g. basic, clinical, population) across the enterprise. The Research Administration department supports investigators and research teams through the provision of creative tools and services while maintaining the highest standards of customer service and promoting a safe, compliant and ethical research environment.

JOB SUMMARY:

The Director, Clinical Research Administration – Pre-Award will oversee the administration and coordination of all pre-award activities related to research study initiation across Atrium Health and Wake Forest University School of Medicine. This leadership role resides within the Office of Clinical Research and is a key position for the success of clinical research administration conduct. The role will provide overall leadership and management for team members; monitor service levels and metrics; address issues as they arise; and will work closely with the Associate Vice President & Assistant Dean of Clinical Research, other Research Administration leadership, investigators and study teams to identify areas for continuous process improvement and deploy solutions to improve team effectiveness, productivity, and performance.

Under the direction of the Associate Vice President & Assistant Dean for Clinical Research, this position will have oversight and management responsibilities for all clinical research pre-award staff and activities. Clinical research pre-award activities include but are not limited to: calendar building in OnCore (clinical trial management system) and ClinCard (electronic participant payment system); confidential disclosure agreement (CDA) and clinical trial agreement (CTA) review, negotiation, and execution; coverage analysis; budget development and negotiation; and activation of clinical research studies in OnCore, ClinCard and EPIC (electronic health record and patient billing system).

EDUCATION/EXPERIENCE:

• Bachelor's degree in a finance or a related field with a minimum of four (4) years of relevant leadership experience required. In some circumstances may consider equivalent years of direct research administration experience in a central office or certifications relevant to the profession in lieu of a bachelor's degree.
• Graduate degree in a related field is preferred.
• Demonstrated experience managing direct reports and completing performance management activities.
• Demonstrated ability to work under pressure, meet deadlines, and process large amounts of information.
• Demonstrated ability to communicate effectively with diverse clientele both verbally and in writing.
• Demonstrated leadership, knowledge, and administrative experience with relevance to clinical research administration (e.g., Clinical Trial Management System (CTMS) utilization, Coverage Analysis, budget development and negotiation, contract review and negotiation) is required.

ESSENTIAL FUNCTIONS:

• Directs clinical research pre-award activities across the Southeast Region of Atrium Health and the Wake Forest University School of Medicine.
• Directs and supervises clinical research pre-award staff members and ensures pre-award activities are carried out by team representatives appropriately.
• Implements personnel actions (e.g., hiring, training, promotion, termination, and organizational changes) for the clinical research pre-award team, following appropriate location-based policies and procedures.
• Directs and oversees teammates responsible for the following clinical research pre-award activities:
• Calendar builds and the financial setup of studies submitted in OnCore;
• Payment schedule builds and the financial setup of studies in ClinCard;
• Coverage analysis of all clinical research studies;
• Budget development, review and negotiation of all clinical research studies;
• Negotiation and execution of all non-federal human subjects research (e.g., industry-funded, foundation-funded) Confidential Disclosure Agreements and industry Clinical Trial Agreements;
• Activation of all clinical research studies in OnCore, ClinCard and EPIC within pre-defined timelines.
• Plans, coordinates, and directs clinical research pre-award workflows in conjunction with institutional and federal policies and guidelines.
• Interfaces with the Institutional Signatories to ensure the rapid execution of all negotiated CDAs and CTAs.
• Evaluates all clinical research pre-award functions and structures to determine the best allocation and utilization of resources.
• Works closely with adjacent Research Administration offices to identify and implement mechanisms to ensure the timely activation of all clinical research studies.
• Develops, implements, and maintains institutional policies and procedures to ensure compliance with federal, state and local regulatory guidelines related to the activation of clinical research studies, research billing compliance, and the protection of human research subjects.
• Meets regularly with Investigators and study teams to receive feedback on services rendered.
• Analyzes and evaluates ongoing activities and services using customer feedback, system reports and metrics to identify areas where adjustments/improvements are needed.
• Shares responsibility with clinical research post-award leadership for the education and assistance provided to study teams in the use and functionality of OnCore and ClinCard.
• Provides guidance/consultative services for clinical trial start-up to Investigators and research staff.
• Ensures compliance with applicable federal, state and local laws and specific regulations by monitoring such requirements on an ongoing basis.
• Stays informed of developments in the field of clinical research budgeting and billing, coverage analysis, Medicare regulations and other related topics.
• Participates in and supports internal and external meetings and committees, as assigned.
• Manages special projects and other initiatives, as assigned.
• Performs other related duties incidental to work described herein.

SKILLS/QUALIFICATIONS:

• Excellent oral and written communication skills
• Strong interpersonal skills and attention to detail
• Experience with computerized databases (e.g., Microsoft Excel), word processing (e.g., Microsoft Word), and presentation software (e.g., Microsoft PowerPoint)
• Ability to manage multiple priorities in a fast-paced environment
• Personnel management experience

WORK ENVIRONMENT:

• Clean, comfortable, well-lit, office environment
• Remote and/or Hybrid work schedule available

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About Us

Wake Forest University School of Medicine (WFUSM) is a U.S. News and World Report top 50 ranked medical school, integrated with a world-class health system, Atrium Health. WFUSM, the academic core of Atrium Health Enterprise, is a recognized leader in experiential medical education and groundbreaking research that includes Wake Forest Innovations, a commercialization enterprise focused on advancing health care through new medical technologies and biomedical discovery. WFUSM, has over $300M in annual, extramural funding that drives a cutting-edge Academic Learning Health System by integrating innovative research with excellent patient care across our enterprise.

Atrium Health is based in Winston-Salem, North Carolina and is part of Advocate Health, which is headquartered in Charlotte, North Carolina, and is the fifth-largest nonprofit health system in the United States, created from the combination of Atrium Health and Advocate Aurora Health. AHWFB is an 885-bed tertiary-care hospital in Winston-Salem – that includes Brenner Children’s Hospital, five community hospitals, more than 300 primary and specialty care locations and more than 2,700 physicians.

Our highly integrated academic and clinical environment is deeply committed to improving health, elevating hope, and advancing healing – for all.

It should be noted that while you are applying on the Wake Forest University School of Medicine Career Site, you will receive communications from the Atrium Health Recruitment Team. Please know that this is an expected process. Thanks in advance for your flexibility.

Organization

Mission, Vision and Culture Commitments

Mission

To improve health, elevate hope and advance healing – for all.

Vision

To be the first and best choice for care.

Culture Commitments

We create a space where all Belong

We Work as One to make great things happen

We earn Trust in all we do

We Innovate to better the now and create the future

We drive for Excellence – always