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: 

1. 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.
2. Graduate degree in a related field is preferred. 
3. Demonstrated experience managing direct reports and completing performance management activities. 
4. Demonstrated ability to work under pressure, meet deadlines, and process large amounts of information.
5. Demonstrated ability to communicate effectively with diverse clientele both verbally and in writing. 
6. 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:

1. Directs clinical research pre-award activities across the Southeast Region of Atrium Health and the Wake Forest University School of Medicine.
2. Directs and supervises clinical research pre-award staff members and ensures pre-award activities are carried out by team representatives appropriately. 
3. 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.
4. Directs and oversees teammates responsible for the following clinical research pre-award activities: 
   1. Calendar builds and the financial setup of studies submitted in OnCore; 
   2. Payment schedule builds and the financial setup of studies in ClinCard; 
   3. Coverage analysis of all clinical research studies; 
   4. Budget development, review and negotiation of all clinical research studies; 
   5. Negotiation and execution of all non-federal human subjects research (e.g., industry-funded, foundation-funded) Confidential Disclosure Agreements and industry Clinical Trial Agreements; 
   6. Activation of all clinical research studies in OnCore, ClinCard and EPIC within pre-defined timelines.
5. Plans, coordinates, a