Research Associate | Urology - Clinical | Days | Full-Time

Overview

JOB DUTIES

Assist in the conduct and coordination of clinical trials by ensuring compliance with clinical protocol requirements, institutional and federal guidelines, and department procedures under the direct supervision of the manager.

Essential Functions

1. Assists with screening and consenting potential participants interested in research clinical studies. Tracks required patient visits and coordinates scheduling with front desk.
2. Adheres to ongoing clinical trial protocol-specific procedures as well as good clinical practice and departmental standard operating procedures.
3. Assists Coordinators with maintaining monthly billing for study visits and documents appropriate fees on research referral forms. Assists Coordinators with the collection of data from patient charts, medical records, interviews, questionnaires, and other sources, and in the overall conduct of research studies.
4. Assists with organization and preparation of study start-up documents, protocol worksheets, and regulatory document forms. Maintains clinical trial documents and regulatory binders; files and archives as needed. Maintains accurate documents including medical licenses and CVs.
5. Completes, submits, and organizes Case Report Forms. Maintains tracking logs for all research regulatory documents including new protocol submission, annual renewals, safety reports, invoices, brochures, etc. Assists with the preparation of initial institutional review board (IRB) submissions, collects and maintains data forms for various studies. Ensures that all IRB files are current and kept secure.
6. Performs audits/quality review of regulatory files, case report forms, informed consents, and other study-related material and/or tracking logs.
7. Searches national databases and creates specific databases, data collection forms, and tracking forms for research purposes.
8. Coordinates and implements research efforts of departmental faculty. Assists faculty with navigating technological and software applications.
9. Sets up visits with study monitors; prepares regulatory documentation for visits; interacts with study monitors during visits to ensure that regulatory documents are accurate and complete.
10. Performs phlebotomy and completes all study lab processing including centrifuging, packaging, shipping, and storage.

Qualifications

SKILLS, QUALIFICATIONS, AND REQUIRED EXPERIENCE

Skills, Knowledge, Abilities

1. Computer literate with proficiency in Microsoft Office (Outlook, Word, Excel, Access, and PowerPoint), Adobe Acrobat, 10-key, and database management.
2. Possesses critical thinking, prioritization, and organizational skills.
3. Capacity to conduct literature searches and evidence-based reviews.
4. Knowledge of research processes and statistical analysis.
5. Demonstrated self-motivation, ability to work independently with particular attention to detail and accuracy.
6. Ability to effectively work under pressure in order to meet deadlines.
7. Ability to manage multiple priorities and meet deadlines.

Experience Requirements

Length of Experience

Type of Experience

Required/Preferred

1 year

Professional experience

required

2 years

Experience in research regulatory experience strongly recommended

preferred

Education Requirements

Degree/Diploma Obtained

Program of Study

Required/Preferred

Bachelors

Health Sciences, Public Health, Research and Statistics

preferred

Additional Details:

Certified Medical Assistant: Certification must be maintained and current.

UFJPI is an Equal Opportunity Employer and Drug-Free Workplace