Clinical Trials Manager – MCG Clinical & Translational Science Position Available In Richmond, Georgia

Clinical Trials Manager MCG Clinical & Translational Science
Job ID
Location
Augusta University
FullPart TimeFullTime
RegularTemporaryRegular
About Us
Augusta University is Gia’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 , students choose Augusta for educational opportunities at the center of Gia’s cybersecurity hub and experiential learning that blends arts and application, humanities, and the health sciences. Augusta is home to Gia’s only public academic health center, w groundbreaking research is creating a healthier, more prosperous Gia, and worldclass clinicians are bringing the medicine of tomorrow to patient care today. Our mission and values make Augusta University an institution like no other.
The University System of Gia isprised of our 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 ananization, and each USGmunity 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 …. and can be found online at .
Additionally, USG supports Freedom of Expression as stated in Board Policy . Freedom of Expression and Academic Freedom found online at Location
Augusta University Health Sciences Campus th Street, Augusta, GA CollegeDepartment Information
The Medical College of Gia is one of the nation’s largest medical schools by class size, with students per class. The educational experience is anchored by the main campus in Augusta, regional clinical campuses for third and fourthyear students across the state and a second fouryear campus in Athens in partnership with the University of Gia. MCG¿s expanding partnerships with physicians and hospitals across Gia currently provides about sites w students can experience the full spectrum of medicine, fromplex care hospitals to smalltown solo practices. MCG and its teaching hospitals also provide postgraduate education to more than residents and fellows in different Accreditation Council for Graduate Medical Educationapproved programs. Our researchers and clinicians focus on what most impacts the health of Gia’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 their expertise with physicians and patients at about clinics and hospitals statewide.
Job Summary
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 trainingmentoring programs to include quality improvement processes.
Responsibilities
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 associatesassistants and data coordinators) and rmendations to hireterminate employees. Quality assessment of work performed by team members, including adnce to protocols, regulatorypliance, meeting deadlines, timeliness, and accuracy of CRFpletion, and adnce 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 andor investigatorinitiated studies. Monitoring Attend andor monitor Presite 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 andor lead process improvement working groups and staff mentoring educational activities. Develop and execute trainingmentoring 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,plete study financial startup (development of theprehensive clinical trials electronic billing grid, budget related to per patient costs, etc.). Work with PIs to assist in study design; estimates of timeeffort required for study visits, procedures, CRFpletion, 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 dutiestasks as assigned.
Required Qualifications
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’ supervisorymanagement experience; OR Bachelor’s degree in Nursing from an accredited college or university and current, active Gia Licensure as a Registered Nurse in good standing; OR Associate’s degree in Nursing from an accredited college or university and current, active Gia Licensure as a Registered Nurse in good standing and a minimum of eight years’ related clinical andor management experience.
Preferred Qualifications
Certified Clinical Research Coordinator (CCRC) or equivalent.
Knowledge, Skills, & Abilities

KNOWLEDGE

Proficient in Microsoft Office and otherputer softwaredatabases. SKILLS
Excellent interpersonal, written, and verbalmunication skills. Detailoriented with stronganizational, customer service and prioritization skills.

ABILITIES

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.
ShiftSalaryBenefits
Shift Days; Monday Friday (Work outside of normal business hours may be required). Pay Grade Salary minimum ,$, annually.
Salary to bemensurate with qualifications of selected candidate within the established range (generally minimummidpoint) of the position. Recruitment Period Until Filled.
Augusta University offers a variety of benefits to fulltime benefitseligible employees and some of our halftime (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 paid holidays.
Also, our fulltime employees who have been employed with us successfully for more than months can be considered for the Tuition Assistance Program. Consider ing 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 ouranization’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.
Other Information
This position is also responsible for promoting a customerfriendly environment and providing superior service to our patients, students, faculty, and employees. “Augusta University is a patientand familycentered care institution, w employees partner every day with patients and families for success.”
Augusta University is a tobaccofree 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, weing applicants from underrepresented groups, including individuals with disabilities and veterans.