Research Program Administrator

This position is within the Department of Medicine and supports the Division of Arthritis and Rheumatic Diseases and the Division of Nephrology and Hypertension. This position is supervisory and oversees the clinical trials research staff volunteers and students who support multiple Principal Investigators (PIs) in the coordination and administration of industry sponsored clinical trials and investigator-initiated studies. The position works with the ARD and NHT Division Managers Administrative Coordinator PIs the DoM Research Office and many others in the day-to-day clinical trials research operations and longer-term development and growth of the enterprise.

Management of clinical research staff and volunteers

Primary supervisor and point of contact for clinical trials support staff (TICRAs RA2s volunteers and visiting students) for the Division of Nephrology & Hypertension and the Division of Arthritis & Rheumatic Diseases.
Assists with oversight and coordination of clinical trials research enterprise for ARD and NHT with the PIs Division Heads and Division Managers.
Plans and leads research team meetings and trainings for research team including the PIs Sub-Is Research Assistants and DoM Research Development Manager.
Works with the Division Manager and PIs for determining study assignments to staff.
Maintains training materials and is the primary onboarding entity for new clinical research staff.
Oversees all studies managed in eCRIS InfoEd Redcap eIRB Florence and other research portals.
Oversees responsibility for hiring and onboarding all clinical research staff and volunteers
If applicable ensures back-up research coordinators (OCTRI) have resources to complete study activities in the event of an absence (study documents/supplies organized and accessible).
Designs and implements procedures and process changes to maximize staff efficiency.
Maintains employee compliance with various certifications.
Assigns daily tasks and schedules to staff and volunteers.

Leads Research Study Coordination

Coordinates with OPAM and Contracts office during budget and contract negotiation process
Coordinates with DoM office and OPAM for account maintenance invoicing and reconciliation.
Actively screens and consents patients for the studies and conduct study visits. This will include coordinating appointments with the PI and/or sub-PI as needed.
Submit modification approvals to the IRB and complete all other IRB reportorial requirements
Completes electronic data entry for research patients in a timely manner.
Maintain and organize study binders as well as prepare for site visits and meet with monitors.
Participate in recruitment activities for active studies.
Coordinates care of research patients with their specialists/PCPs

Finance
Analyzes budgetary data verifies figures and develops budget proposals; recommends allocation of budgetary funds.
Invoices/processes invoices with industry sponsors.
Works with the Division Manager and DoM Grants and Contracts Coordinator on financial management of awards as well as responds to questions regarding deficits and surplus.

Education

Bachelors degree and two years of experience leading projects; OR
Associates degree and three years of experience leading projects; OR
Equivalent combination of education training and experience

Experience

At least three years of administrative support experience supporting a team of 10 or more

Job Related Knowledge Skills and Abilities (Competencies)

• Working knowledge of medical terminology moderate to advanced computer skills including proficiency in Excel and Word.
• Must have flexible style with excellent time management and multitasking skills; ability to work well with all levels of organization and to work both effectively independently and as part of a team; ability to keep clear accurate and precise written and electronic documentation; strong analytical skills; fine attention to detail and refined troubleshooting skills.

Education

Bachelors degree with major courses in the field of research is preferred

Experience

• Prior clinical research experience in a complex health system or university setting
• Prior experience leading a clinical trials research team
• Prior supervisory experience in a clinical research setting

Job Related Knowledge Skills and Abilities (Competencies)

• Advanced clinical examination & vital signs assessment
• Phlebotomy training
• Familiarity with health record and research database systems

Registrations Certifications and/or Licences

SOCRA Clinical Research Professional Certification Examination
(CCRP)

Working Conditions

• General work schedule will be a flexible Monday Friday shifts (5 days per week). Environmental exposures include working with lab reagents human tissues (blood and saliva) and general patient contact.
• Hybrid (remote and in-person work) is allowed but is dictated by patient visits patient care needs and PI schedules. Schedules are discussed and assessed weekly with the larger team to determine support for in-person to-dos.

Physical Demands & Equipment Usage

Ability to work at a computer for up to four hours at a time. Ability to move around the campus as needed for research studies and meetings. Ability to work remotely for multiple days per week.