OPS Clinical Research Coordinator - Vascular Surgery

Vascular Surgery

Gainesville, Florida

JOB DETAILS
SKILLS
Adverse Events, Animal Care, Billing, Clinical Practices/Protocols, Clinical Research, Clinical Trial, Communication Skills, Data Collection, Federal Laws and Regulations, File Maintenance, GCP (Good Clinical Practices), GLP (Good Laboratory Practices), HIPAA (Health Insurance Portability and Accountability Act), IRB/IEC (Institutional Review Board/Independent Ethics Committee), Knowledge Base, Laboratory, Maintain Compliance, Medical Assistance, Medical Records, Needs Assessment, Operating Room Nursing, Operations Research, Organizational Skills, Patient Care, Patient Education, Pharmacy, Pre-Clinical Trials, Protocol Design, Record Keeping, Regulations, Reporting Skills, Research Protocols, Specimens/Samples, Time Management, Vascular Surgery
LOCATION
Gainesville, Florida
POSTED
2 days ago
Classification Title:

OPS Clinical Research Coordinator 

Classification Minimum Requirements:

Associate’s degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience

Job Description:

Coordination of Protocol Subjects & Data Collection
Performs subject screening and consent for clinical protocols under direction of Principal Investigator.
Serves as patient resource and educator for information regarding the study or clinical symptoms.
Prepares and ships central laboratory samples as per protocol requirements. Collects baseline and follow-up data from the medical record. Documents findings in appropriate source records and case report forms.
Schedules and attends clinic appointments for patients as required by protocol. Communicates with nursing staff and OR Staff about patient care according to protocols. Assists with operating room protocol requirements where appropriate. Records patient symptoms and adverse events in conjunction with care providers. Reports and follows up adverse events and serious adverse events, after discussion with Principal Investigator, to sponsor and Investigational Review Board as required by protocol

Coordination of Protocol Compliance
Maintains knowledge base of Good Clinical Practice Guidelines and Federal Code of Regulations regarding clinical trial conduct. Coordinates and maintains HIPAA compliance for assigned studies. Communicates with interdisciplinary health team in care of patients involved in research studies to ensure regulatory compliance.
Interacts with local laboratories and diagnostic study centers to ensure clinical protocol requirements are complete for studies. Coordinates efforts of Investigational Pharmacist and maintains site records for Good Clinical Practice and sponsor guidelines.

Research Support
Assists medical and scientific partners to design protocol methodologies for basic science, preclinical studies, and clinical protocols. Helps with protocol development and protocol endpoints to ensure statistical and clinical relevance of studies. Assesses clinical needs by performing literature review and discussion with faculty advisors within Division. Prepares and submits filings of protocols to Investigational Review Board and Animal Care Committees as needed. Designs Case Report Forms and Source Documents for clinical protocols where required. Assists with grant development projects. Maintains awareness of Good Laboratory Practices as needed for preclinical studies within Division. Assists with manuscript preparation and abstract submission for principal investigators.

Submits protocols to the RAC and IRB offices to assure compliance under the direction of the senior study coordinator. Organizes and maintains regulatory files for clinical studies performed within Division.
Interacts with institutional Investigational Review Board under direction of Principal Investigator for clinical research protocols. 
 
Tracks the type of study services performed to ensure that they are compensated appropriately.
Performs billing review for study subjects.
Dispense human subjects’ payments to study participants
 
 
Expected Salary:

$23.50 per hour

Required Qualifications:

Associate’s degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience

Preferred:
Excellent communication skills; must be able to communicate with patients and family participating in
clinical trials.
Experience as research coordinator preferred.
Experience with patient data and/or databases.
Proficient time management skills and ability to successfully manage multiple studies.
Special Instructions to Applicants:

In order to be considered, you must upload your cover letter and resume. 

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

Health Assessment Required:Yes

 

About the Company

V

Vascular Surgery