Data Coordinator 2
Job Title: Data Coordinator 2
Location: Augusta University
Full/Part Time: Full-Time
Job ID: 228355
Required Qualifications Associate's degree from an accredited college or university.
Completion of two years of college level coursework and two years of related work experience.Knowledge, Skills, & Abilities Ability to maintain confidentiality
High attention to detail and change management
Excellent interpersonal, written and verbal communication skills
Proficient in Microsoft Office and other computer software/databases
Detail-oriented with strong prioritization, multi-tasking, organizational, problem-solving and time-management skillsPreferred 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)Responsibilities This positions 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). The duties include, but are not limited to:
- Duties include, but are not limited to: providing lead coordinator support to assigned studies and assisting other lead coordinators with IRB submission of both local and central IRBs; completion of all IRB and submission forms, internal approvals, obtaining signatures (electronic and ink), completion of training, delegation of duties logs and all forms pertinent to each submission, etc. Assist with FDA submissions for investigator-initiated studies. Assist with IND safety reports, internal approvals and study start-up.
- Duties include but are not limited to: track and update study status, task lists and generate reports within the OnCore data management system. Assist with uploading and onboarding of staff and faculty to sponsor regulatory software such as SIP; upload documents into electronic regulatory binder through Veeva Vault, Box. Maintain current eRegulatory files for studies.
- Duties include but are not limited to: assist with facilitating meetings (DSMB, SIV, staff), routing documents for signatures, training and review; and other regulatory, data and administrative support duties as assigned.
- Perform all other related duties as assigned.
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.