Data Coordinator 2- GCC Oncology Trials

Job Details

Data Coordinator 2- GCC Oncology Trials

Job ID: 297076
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 12,000 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. Our mission and values make Augusta University an institution like no other.

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
The Medical College of Georgia (MCG) is one of the nation's largest medical schools by class size, with 304 students per class. The MCG educational experience is anchored by the main campus in Augusta, with regional clinical campuses for third- and fourth-year students across the state, and two four-year campuses located in Athens (in partnership with the University of Georgia) and in Savannah (in partnership with Georgia Southern University). MCG's expanding partnerships with physicians and hospitals across Georgia currently provide more than 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 approximately 575 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.

Job Summary
This position performs a variety of complex duties involved providing regulatory support for the regulatory coordinators within the CTO. Duties include, but are not limited to: provide regulatory support as lead regulatory coordinator for studies, assist with sponsored and investigator-initiated trial IRB submissions including initial submissions, amendments, continuation and annual reports (completion of study documents, IRB forms, etc., as needed for each submission), IND safety reports, ensuring the submissions are in compliance within federal, state and local regulations; assist with obtaining local approvals (biosafety, radiation safety, IT requests, etc.); obtaining electronic and ink signatures, assist with submissions to the FDA for the investigator-initiated studies (initial IND requests, amendments and annual reports, submitting hard copies of each submission to the FDA) and completion of FDA forms; procurement of medical/lab supplies and creation of lab kits for investigator-initiated studies; assist in ensuring lab kits and other study materials are obtained for sponsored studies; assist in the creation of forms including source documents, case report forms and manuals (operations, CRF and lab manuals) and standard operating procedures (SOPs).

Responsibilities
The responsibilities to include, but are not limited to:
Responsible for onboarding new employees and investigators who wish to conduct clinical trials at the Georgia Cancer Center, including ensuring appropriate documentation is gathered, training is done, and access to the appropriate portals is granted.
Responsible for adding new personnel onto each study they will serve as site staff on. This includes submitting to the AU IRB, routing training, and getting the appropriate documentation signed before site staff participates in a study.
Responsible for updating personnel responsibilities on a study, removing personnel who have left the institution, and granting accesses to various portals, including any new portals the study team may be required to access
Other duties as assigned.

Required Qualifications
Associate's degree from an accredited college or university in a related field.
OR
Completion of two years of college level coursework and two years of related work experience.

Preferred Qualifications
Oncology research specific knowledge and experience preferred; Familiarity with medical terminology; Experience in database management software - preferably OnCore; Certification from the Association of Clinical Research Professionals as a Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Associate (CCRA).

Knowledge, Skills, & Abilities
Proficient in Microsoft Office and other computer software/databases.
SKILLS
High attention to detail and change management.
Excellent interpersonal, written, and verbal communication skills.
Detail-oriented with strong prioritization, multi-tasking, organizational, problem-solving and time-management skills.
ABILITIES
Ability to maintain confidentiality.