Clinical Trials Manager - MCG Clinical & Translational Science
Augusta, Georgia 30912
Clinical Trials Manager - MCG Clinical & Translational Science
Job ID: 264791
Location: Augusta University
Full/Part Time: Full Time
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 9,000 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.
Augusta University- Health Sciences Campus: 1120 15th Street, Augusta, GA 30912
The Medical College of Georgia is one of the nation's largest medical schools by class size, with 260 students per class. The educational experience is anchored by the main campus in Augusta, regional clinical campuses for third- and fourth-year students across the state and a second four-year campus in Athens in partnership with the University of Georgia. MCG's expanding partnerships with physicians and hospitals across Georgia currently provides about 350 sites where students can experience the full spectrum of medicine, from complex care hospitals to small-town solo practices. MCG and its teaching hospitals also provide postgraduate education to more than 500 residents and fellows in 50 different Accreditation Council for Graduate Medical Education-approved programs. Our researchers and clinicians focus on what most impacts the health of Georgia's and America's children and adults, including cardiovascular biology and disease, cancer, neurosciences and behavioral sciences, public and preventive health, regenerative and reparative medicine, personalized medicine, and genomics. Our physician faculty also share their expertise with physicians and patients at about 100 clinics and hospitals statewide.
The Clinical Trials Manager provides advanced level professional support and supervision to research staff within the Clinical Trials Office (CTO). This individual will be directly responsible for working with senior research leadership and administrators to implement processes and initiatives that will improve efficiency, fiscal soundness and to grow the clinical research program. As a key member of the CTO leadership team, they will lead clinical research operations, be responsible for monitoring workloads to include determining appropriate staffing levels. This individual will take the lead in the development and execution of CTO training/mentoring programs to include quality improvement processes.
The duties include but are not limited to:
Supervision: Responsible for the direct supervision of clinical research staff that includes monitoring workloads, performing annual staff evaluations, determining appropriate staffing levels for the clinical research staff (Nurse clinicians, research associates/assistants and data coordinators) and recommendations to hire/terminate employees. Quality assessment of work performed by team members, including adherence to protocols, regulatory compliance, meeting deadlines, timeliness, and accuracy of CRF completion, and adherence to AU and CTO policies and guidelines.
Clinical Research: Leads the daily clinical research operations for one or more key areas. Study design: Oversee protocol development and collection of central documents. Clinical research services: Recruitment of new study participants, study management, regulatory, data management, assist with unfunded and/or investigator-initiated studies. Monitoring: Attend and/or monitor Pre-site visit (PSV), Site initiation visit (SIV), Monitoring visit (MV), as needed assist with audit preparation.
Quality Improvement: Assist with developmental, revision, and continuous evaluation of clinical research department standards and policies; participate in and/or lead process improvement working groups and staff mentoring educational activities. Develop and execute training/mentoring programs, quality improvement processes, the development of Internal Guidance Documents and other projects as assigned. Working collaboratively with other research teams, create and administer a continuous quality improvement program for CTO.
Financial Management: Work in collaboration with the Regulatory and Financial team to assist with the development of addressing study balances and working on a solution to address those that are running in the negative. In collaboration with the primary coordinator, Research Development Services, and Clinical Translational Finance Manager, complete study financial startup (development of the comprehensive clinical trials electronic billing grid, budget related to per patient costs, etc.). Work with PIs to assist in study design; estimates of time/effort required for study visits, procedures, CRF completion, and data entry into sponsor data portals; budget development; study feasibility.
Other: Actively participate in operational review of new protocols and amendments for feasibility of conduct. Perform all other related duties/tasks as assigned.
Bachelor's degree in Chemistry, Biology, Biochemistry, Cell Biology or other natural healthcare or material science from an accredited college or university and a minimum of five years' experience in executing multidisciplinary clinical research protocols and a minimum of two years' supervisory/management experience; OR Bachelor's degree in Nursing from an accredited college or university and current, active Georgia Licensure as a Registered Nurse in good standing; OR Associate's degree in Nursing from an accredited college or university and current, active Georgia Licensure as a Registered Nurse in good standing and a minimum of eight years' related clinical and/or management experience.
Certified Clinical Research Coordinator (CCRC) or equivalent.
Knowledge, Skills, & Abilities
Proficient in Microsoft Office and other computer software/databases.
Excellent interpersonal, written, and verbal communication skills. Detail-oriented with strong organizational, customer service and prioritization skills.
Ability to maintain confidentiality and work independently. Ability to identify team inefficiencies, study concerns, and provide assistance in problem solving. Ability to make decisions clearly and effectively as they relate to personnel assignment, study management, and other related matters.
Shift: Days; Monday - Friday (Work outside of normal business hours may be required).
Pay Grade: 21
Salary minimum: 60,058-$81,078 annually.
Salary to be commensurate with qualifications of 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 candidates are required to successfully pass a Background Check review prior to starting with Augusta University.
The primary work location for this position is within the Augusta University Medical Center or other Augusta University Health System Clinic Space and is subject to the Centers for Medicare & Medicaid Services guidelines. The selected candidate will be required to provide proof of COVID vaccination or an approved exemption. Your application to this position confirms you are aware of this requirement and agree to provide proof of either COVID vaccination or our organization's approval of a medical or religious exemption.
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 the course of their employment and beyond.
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!
https://www.augusta.edu/hr/jobs/ Search for Job ID: .
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://careers.hprod.onehcm.usg.edu/psp/careers/CAREERS/HRMS/c/HRS_HRAM_FL.HRS_CG_SEARCH_FL.GBL?Page=HRS_APP_JBPST_FL&Action=U&FOCUS=Applicant&SiteId=12000&JobOpeningId=264791&PostingSeq=1
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Date Posted : 11/15/2023
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