Research Coordinator
US-TX-Houston
careers
Req #: 48298
Type: Full Time
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Overview: We have an exciting Research Coordinator opportunity for an experienced professional to join our team at Pediatrix Medical Group. We are a national organization, and one of the nation's largest providers of prenatal, neonatal and pediatric services. Talented business professionals from diverse backgrounds choose Pediatrix because we are an exciting and innovative company that focuses on a team approach to improve the lives of patients everywhere. We offer a diverse range of opportunities, competitive salaries and benefits, and a commitment to clinical excellence, we are confident that you'll love being a part of the Pediatrix team. Responsibilities: The Research Coordinator is responsible for coordinating, organizing and facilitating processes related to the development and completion of clinical research trials within their assigned Unit. The Research Coordinator will be a liaison between clinicians, investigators, Clinical Research Nurse, and the hospital team. * 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 * Coordinates the development of forms and surveys; assist in writing procedural manuals for data collection and coding for research trials. * Performs data collection from electronic medical records (EMR), accurately enters data into databases or electronic data capture systems. * Screens patients record to identify potential study participants based on study eligibility criteria and approaches families to discuss participation, obtain informed consent, and answer questions regarding study protocols. * Maintains budget spreadsheet for each clinical trial and coordinates payments with the Pediatrix Center for Research, Education, Quality, and Safety. * Creates and maintains master spreadsheets that include but are not limited to participant lists, consent approvals and maintenance of essential documents (FDA and trial specific) required for clinical Trials and is responsible for obtaining completed, updated or current versions of all documents. * Conducts audits on regulatory, IRB, site study files, and other study related documents for completeness as well as expedites incoming questions/problems by site Investigators and research team and coordinates the solution with appropriate resources. * Writes and/or revises Standard Operation Procedures (SOPs) as directed and maintains master copy of SOPs and ensures adherence to Pediatrix and Hospital Facility SOPs. * Screens and prioritizes all research requests and provides prompt and courteous, professional and accurate information in all communications in dealing with physicians / care team members and other departments. * Follows all facility, organization and department precautions and procedures in the performance of all job duties to ensure a safe work environment for others. * Addresses team member and hospital concerns to ensure team members are meeting performance expectations. * Monitor and review Medical Sponsor reports and timely submission by physician sponsor, to ensure adherence to Medical Sponsor Policy. Qualifications: Education/Experience: * Associate 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 * Minimum of 1-2 years of prior experience in clinical research coordination * Ability to demonstrate understanding FDA, HIPAA and good clinical practice guidelines for research * Ability to coordinate several large multi-center trials at one time; ability to communicate professional and effectively, excellent written and verbal communication skills * Intermediate knowledge in MS Office (MS Word, Excel, Power Point).
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