Clinical Research Coord II
Apply now
Job no: 538628
Work type: Staff Full-Time
Location: Main Campus (Gainesville, FL)
Categories: Health Care Administration/Support
Department:29050100 - MD-MEDICINE-ADMINISTRATION
| Classification Title: |
Clinical Research Coordinator II
|
| Classification Minimum Requirements: |
Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
|
| Job Description: |
Coordination and Patient Engagement
- Assist Principal Investigator with all study related duties
- Identification and Recruitment of subjects
- Communication with subjects via telephone, email, and/or in person to gather necessary research information, schedule appointments, remind subject of protocol requirements, and address questions and concerns
- Prepare and compile necessary items for research study appointments
- Schedule subject visits in the Clinical Research Center (CRC) and with other necessary clinic or ancillary offices
- Coordinate with Investigational Pharmacy for study visits requiring study drugs and arrange for orders and dispensing
- Obtaining Informed Consent
- Screening and obtaining accurate and complete medical history
- Documenting and maintaining accurate patient records
- Appropriately assess and document adverse events
- Dispensing Investigational products
- Documenting investigational product accountability
- Monitoring of subjects enrolled in trials in accordance with medical and health management standards, study protocols and GCP/ICH guidelines
- Obtain vitals and collect study samples
- Sample processing
Study Regulatory Management
This position must be familiar with current research protocol guidelines and assist with reviewing new protocols.
- Preparation of documents required for initial submission to UF research offices and for the sponsor.
- Preparing and submitting regulatory documents for revisions and continuing reviews.
- Development of recruitment and advertising materials
- Responsible for preparing reports for the Institutional Review Board in a timely manner
- Development of Informed Consent, incorporating UF required language and local regulations into consent templates
- Development of Source Documents
- Manage essential regulatory documents
- Filing source documents
- Data Entry/ Query Resolution per sponsor guidelines
- Facilitating sponsor/monitor visits
- Facilitate study closeout procedures
- Retain Records/Archive documents after closeout
Financial
- Participate in development of study budgets
- Requesting Cost of Service from Ancillary departments
- Management of study billing plans (including OnCore entry)
- EPIC Charge Review of study subject billing
- Participate with finance team in the tracking and management of study finances including sponsor invoicing and resolving study subject billing issues
- Management of HSP payment tracking and compliance
Other duties as assigned – not defined herein but associated with study management and integral to study team.
|
| Expected Salary: |
$51,000 - 61,000/annually
|
| Required Qualifications: |
Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
|
| Preferred: |
Prior experience with clinical research.
Experience with MS Word, Excel, and data management preferred (InForm, REDCap, and Oncore)
EPIC EMR System
|
| Special Instructions to Applicants: |
In order to be considered, you must upload your cover letter and resume.
This position is time-limited. Application must be submitted by 11:55 p.m. (ET) of the posting end date.
|
| Health Assessment Required: |
Yes |
Advertised: Eastern Standard Time
Applications close: Eastern Standard Time
Back to search results Apply nowRefer a friend