Job Description

Director, Clinical Trials Office

Job ID: 276126

Location: Augusta University

Full/Part Time: Full Time

Regular/Temporary:

*

About Us

Augusta University is Georgia's innovation center for education and health care, training the next generation of innovators, leaders, and healthcare providers in classrooms and clinics on four campuses in Augusta and locations across the state. More than 10,500 students choose Augusta for educational opportunities at the center of Georgia's cybersecurity hub and experiential learning that blends arts and application, humanities, and the health sciences. Augusta is home to Georgia's only public academic health center, where groundbreaking research is creating a healthier, more prosperous Georgia, and world-class clinicians are bringing the medicine of tomorrow to patient care today. Ourhttps://www.augusta.edu/about/mission.php make Augusta University an institution like no other.

Thehttps://www.usg.edu/hr/orientation/welcome_to_the_board_of_regents_university_system_office is comprised of our 26 institutions of higher education and learning as well as the System Office. Our USG Statement of Core Values are Integrity, Excellence, Accountability, and Respect. These values serve as the foundation for all that we do as an organization, and each USG community member is responsible for demonstrating and upholding these standards. More details on the USG Statement of Core Values and Code of Conduct are available in USG Board Policy 8.2.18.1.2 and can be found online at https://www.usg.edu/policymanual/section8/C224/#p8.2.18_personnel_conduct

Additionally, USG supports Freedom of Expression as stated in Board Policy 6.5 Freedom of Expression and Academic Freedom found online at https://www.usg.edu/policymanual/section6/C2653.

Location

Augusta University -

Our Health Sciences Campus: 1120 15th Street, Augusta, GA 30912

Our Summerville Campus: 2500 Walton Way, Augusta, GA 30904

College/Department Information

Augusta University is actively participating in ways to improve the health and lives of the people of our community, our state, and around the world. To do this, we conduct research, a great deal of which is done through clinical trials in humans (known as human subject research). There are many federal requirements that all research institutions must meet in order to conduct human subject research. We have an outstanding, dynamic, and growing group of researchers, administrators, and office staff ready to assist. Our defined strengths lie in the areas of: Conventional clinical trials; Community, population health, social, behavioral, and educational research; Community education; Well-defined research initiation process; Ongoing and continued support for conduct of research; Integrated and technology advanced IT systems to support efficient research processes.

Job Summary

The incumbent is vital to the design, preparation, planning, implementation, and review of clinical trials for Colleges and Schools throughout AU, including MCG Departments of Medicine, Surgery, Neurology, Obstetrics and Gynecology, Otolaryngology, Ophthalmology, and Urology (and multiple sections within some of those departments, such as, Cardiology, Nephrology, and Gastroenterology). The position will support both grant and commercially-funded sponsored and investigator-initiated clinical studies while ensuring adherence to institutional, local, federal, state, and institutional ethical standards. They will be responsible for managing the startup activities of clinical trials, managing the coordination of the study including management of staff including nurses, research associates, research assistants, etc., and overseeing contract negotiations, managing executed contracts, and ensuring that deliverables are executed in a timely and professional manner, and coordinating all clinical research operations with other offices. Develop key performance indicators. The incumbent is responsible for the day-to-day management and planning of research studies and research study staff, reporting to the Assistant VP of Research Operations.

Responsibilities

The duties include, but are not limited to:

Clinical Trial Management:
Contract negotiations and planning

Study management

Provides planning, management, supervision, and oversight for the Clinical Trials Office, staff, and protocols managed by the department.

Works closely with leaders in Research Administration including the Division of Sponsored Programs Administration, Information Technology, Legal Affairs Office, IRB Office, Human Resources, Research Development Services, the Wellstar MCG Health System, Medical College of Georgia, and Business Managers to support the "start-up", on-going management, and close out of clinical research studies.

Assess clinical trial protocols and sponsored contracts ensuring:

• The needs and costs of protocol ensuring that budgets are negotiated with sponsors which ensure that actual costs are recovered or that Investigators are aware of potential funding deficits. Deliverables are provided in accordance with the specifications and timeliness of the contract.
• Personnel are available to support and conduct the regulatory requirements, study specific procedures, and all requirements of the contracts. Working with the team leads to monitor that personnel are conducting the study in accordance with study procedures.

Ensures that research studies are Initiated in a prompt manner, managing the process effectively, addressing concerns and as applicable making changes in a time-sensitive manner.

Represents AU on collaborative clinical research initiatives with associated entities including the Wellstar MCG Health, the Charlie Norwood Veterans Affairs Medical Center, other academic institutions and organizations. Establishes and maintains mutually beneficial relationships.

Financial Grant Management:
Assess clinical trial protocols and sponsored contracts ensuring:

• The needs and costs of protocol ensuring that budgets are negotiated with sponsors which ensure that actual costs are recovered or that Investigators are aware of potential funding deficits. Deliverables are provided in accordance with the specifications and timeliness of the contract.
• Personnel are available to support and conduct the regulatory requirements, study specific procedures, and all requirements of the contracts. Working with team leads to monitor that personnel are conducting the study in accordance with study procedures.

Provide Clinical Care & Conduct Study Visits:
Schedule and conduct study visits, including but not limited to coordination of visit, obtain vital signs, concomitant medicine review, administration of study agents, obtaining specimen storage and/or shipment, preparation for future patient visits, and coordination of monitor visits.

Personnel Management:
Coordination and integration of activities under the control of CTO Managers.

Provide oversight and management of Clinical Trials Office staff.

Completing yearly reviews and oversight for the management of the core staff. Provide appropriate coaching, counseling, hiring, or termination of employees as required.

Process Improvements and Metrics:
Maintains systems that log, track, and report the status of agreements, contracts, IRB reports/approvals/continuations, FDA reports, and other applicable reports and ensures compliance with meeting deadlines and expiry dates.

Develop systems to identify the needs of investigators, develop external relationships with drug companies, device companies, and other research funding sources, and consortium.

Identify opportunities for consolidation and reorganization of CTO staff, processes, and systems.

Assess clinical research activities and develop short/long term goals/strategic plans, as well as improve efficiency, compliance with regulations, and fiscal integrity of clinical research studies.
Proactively providing updates to interested parties as needed .

Develops and produces annual reports in conjunction with the Business Manager to convey the overall productivity and financial health of CTO.

Assist interested AU investigators in the process for Initiating research studies and protocols and/or in the negotiation of new contracts with sponsors.

Ensure compliance with institutional, local, and federal policies providing and managing local policies and procedures to ensure compliance.

Identifying process inefficiencies and implementing corrective actions.

Marketing the use of CTO to Internal and external users.

Actively identify opportunities to increase the quantity of clinical trials at AU and provide support to investigators to implement these approaches.

Maintain CTO practices and facilities in compliance with institutional policies and expectations.

Other Duties:
Perform all other related duties as assigned.

Required Qualifications

Bachelor's degree from an accredited college or university with a minimum of seven years of progressively responsible experience in an academic or research setting, including experience in a clinical trials office or clinical trials administration.
OR
Registered Nurse with a minimum of five years of progressively responsible experience in an academic or research setting, including experience in a clinical trials office or clinical trials administration.

Knowledge, Skills, & Abilities

Proficient in Microsoft Office and other computer software/databases with the ability to learn and master new programs and other related software as needed. Team leader with strong history of change management and process improvement. Working knowledge of FDA, GCP, IRB policies; Clinical Trial industry including negotiations with CRO and pharma companies; and clinical trial budget budgeting principles, forecasting, billing, and management of contract deliverables, etc.

SKILLS

Excellent interpersonal, written, and verbal communication skills. Detail-oriented with strong organizational, multi-tasking, customer service, judgement, problem solving, and time management skills with the ability to foster these skills in employees and within the CTO.

ABILITIES

Ability to maintain confidentiality. Ability to display a willingness to work with other members of the organization. Ability to interpret, convey, explain, and uphold regulatory and institutional requirements. Strategic thinker with the ability to manage multiple projects and initiatives, both collaboratively and independently. Responsible leader with ability to foster growth and development of employees, empowering them to implement improvements and change.

Shift/Salary/Benefits

Shift: Days; Monday - Friday (Work outside of normal business hours may be required) .

Pay Band: B17

Salary to be commensurate with qualifications of the selected candidate within the established range (generally minimum-midpoint) of the position.

Recruitment Period: Until Filled.

Augusta University offers a variety of benefits to full-time benefits-eligible employees and some of our half-time (or more) employees.

Benefits that may be elected could include health insurance, dental insurance, life insurance, Teachers Retirement System (or Optional Retirement Plan), as well as earned vacation time, sick leave, and 13 paid holidays.

Also, our full-time employees who have been employed with us successfully for more than 6 months can be considered for the Tuition Assistance Program. Consider applying with us today!

Conditions of Employment

All selected candidates are required to successfully pass a Background Check review prior to starting with Augusta University.

If applicable for the specific position based on the duties: the candidate will also need to have a credit check completed for Positions of Trust and or approved departmental Purchase Card usage.

Motor vehicle reports are required for positions that are required to drive an Augusta University vehicle.

For Faculty Hires: Final candidates will be required to provide proof of completed academic degree(s) as well as post-secondary coursework in the form of original transcript(s). Those candidates trained by a foreign institution will also be required to provide an educational/credential evaluation.

All employees are responsible for ensuring the confidentiality, availability, and integrity of sensitive [patient, student, employee, financial, business, etc.] information by exercising sound judgment and adhering to cybersecurity and privacy policies during their employment and beyond.

Other Information

This position is also responsible for promoting a customer-friendly environment and providing superior service to our patients, students, faculty, and employees. "Augusta University is a patient-and family-centered care institution, where employees partner every day with patients and families for success."

Augusta University is a tobacco-free environment, and the use of any tobacco products on any part of the campus, both inside and outside, is strictly prohibited.

Equal Employment Opportunity

Augusta University is proud to be an equal opportunity employer, welcoming applicants from underrepresented groups, including individuals with disabilities and veterans.

How To Apply

Consider applying with us today!

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Select University Faculty & Staff > External Applicants if you are a candidate from outside the university.

Select University Faculty & Staff > Internal Applicants if you are a current university employee.

If you need further assistance, please contact us at 706-721-9365.

To apply, visit https://apptrkr.com/5593381

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