Overview
The Research Coordinator is responsible for coordinating, organizing and facilitating processes related to the development and completion of clinical research trials.
This person will be a liaison between Investigators, Study Coordinators, Clinical Research Associates, and the Clinical Research Team.
Responsibilities Demonstrates understanding of applicable ICH Good Clinical Practice Guidelines, FDA regulations, and HIPAA regulations.
Prepare clinical research proposals for submission to funding bodies such as industry sponsors, private foundations, and government entities.
Coordinates the collaborative effort between IS department and research team in the production, testing, and implementation of the latest version of the Clinical Research System.
Responsible for writing, performing, and tracking testing scripts related to the electronic data capture system for trials.
Responsible for acting as the administrator or other assigned role in the Clinical Research System.
Coordinates the completion of site agreements and research contracts with the director, administration, legal department, and site representatives.
Maintain Internet and Intranet websites dedicated to research personnel and trials through MedSeek SiteMaker software program.
Assist with planning of investigator meetings.
May require travel to assist with investigator meetings on site.
Review research protocols for clarity, required elements, human subject's protection issues, and research compliance.
Proof protocols, manuscripts, and other related research documents for proper formatting, grammar, spelling, etc.
as well as track versions for sponsors.
Coordinate the development of forms and surveys; assist in writing procedural manuals for data collection and coding for research trials.
Maintain budget spreadsheet for each clinical trial and coordinates payments with Director and the accounting department.
Create and maintain master spreadsheets that include but are not limited to, participant lists, IRB approval and consent approvals, and essential documents for each site participating in a clinical trial.
Responsible for collection and maintenance of essential documents (FDA and trial specific documents) required for clinical trials.
Responsible for obtaining completed, updated or current versions of all documents.
Responsible for writing, performing, and tracking (Remedy System) testing scripts related to the electronic data capture system for one or more trials.
Interact with other departments within the Corporate Office to facilitate the research projects that include but are not limited too, legal department, user services department, accounting department, travel, and marketing.
Conduct audits on regulatory, IRB, site study files, and other study related documents for completeness.
Expedite incoming questions/problems by site Investigators and research team and coordinate the solution with appropriate resources.
Write and/or revise Standard Operating Procedures (SOPs) as directed.
Maintain master copy of SOPs.
Follow company and departmental SOPs.
Screens and prioritizes all requests and provides prompt, courteous, professional, and accurate information in all communications in dealing with physicians and other departments.
Responsible for following all facility, organization, and department precautions and procedures in the performance of all job duties to ensure a safe work environment for self and others.
Other duties as assigned.
Qualifications
Associate's degree (A.
A.)
or equivalent from two-year College or technical school; or six months to one year related experience and/or training; or equivalent combination of education and experience.
This position requires excellent organizational and management skills, resource planning, and the ability to work both autonomously and in teams.
Understanding of FDA, HIPPAA and good clinical practice guidelines for research.
Ability to coordinate several large multi center trials is highly desirable.
Previous experience working on industry sponsored trials.
Experience working with Clinical Trial Management systems.
Intermediate knowledge of Excel and other Microsoft Office programs.
Experience with preparation of research proposals to funding entities.
Benefits and Compensation Benefits for Full Time employees and qualified dependents: Medical, Dental, Vision Insurance Progyny Fertility Benefits Teladoc Health and Second Opinion Services 401(K) Thrift Program & Sharing Plan** Employee Stock Purchase Plan (ESPP) - 15% discount* Basic Employee; Spouse; Child Life Insurance Accidental Death and Dismemberment (AD&D) Employee Optional Life and AD&D Short & Long Term Disability Pre-Tax Health Savings Accounts (HSA) Employee and Dependent Flexible Spending Account (FSA) Family Medical Leave Act (FMLA) Parental Leave Benefit Sick Pay Bank Employee Assistance Program (EAP) Group Aflac Policies Identity Theft Protection Employee Charitable Fund Care.com Continuing Education Assistance Various Discount Programs
*Part Time Regular employee classifications also receive this benefit
**Available to part-time regular and part-time casual employees aged 21 and over
About Us
Pediatrix Medical Group is one of the nation's leading providers of highly specialized health care for women, babies and children.
Since 1979, Pediatrix has grown from a single neonatology practice to a national, multispecialty medical group.
Pediatrix-affiliated clinicians are committed to providing coordinated, compassionate and clinically excellent services to women, babies and children across the continuum of care, both in hospital settings and office-based practices.
The group's high-quality, evidence-based care is bolstered by significant investments in research, education, quality-improvement and safety initiatives.
Please Note: Fraudulent job postings/job scams are becoming increasingly common.
All genuine Pediatrix job postings can be found through the Pediatrix Careers site: www.pediatrix.com/careers.
Pediatrix is an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.