Hackensack Meridian Health
Location
Hackensack, NJ | United States
Job description
Our team members are the heart of what makes us better.
At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It’s also about how we support one another and how we show up for our community.
Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.
The primary function of the Research Coordinator is to coordinate and perform all the associated duties associated with coordination and implementation of the conduct of clinical research trials and projects.
The day in the life of the Research Coordinator at Hackensack Meridian Health includes:
- Assists and conducts literature review, appraisal and grading of evidence and collaborates on proposal development
- Prepare and submit institutional review board application.
- Act as a liaison between Institutional Review Board(s) principal investigators, sub-investigators, assuring compliance with regulatory and institutional mandates and regulations inclusive of but not limited to amendments to protocols and/or modifications to study design as appropriate.
- Reports all serious adverse events to sponsor and IRB(s).
- Serves as primary study coordinator ensuring adherence to the research protocol and provides periodic updates to Principal Investigator on study progress.
- Assist in the development of forms, questionnaires, and completes case report forms and maintains source document
- Creates and maintains regulatory binders and files for assigned protocols
- Collaborates with the research nurse coordinator in creating source document
- Screens research subject /participants as delineated in study specific eligibility criteria
- Obtains informed consent
- Assures follow-up on all protocol patients by maintaining updated records, reviewing active patient lists for correct and current materials, and co-investigators of diagnostic tests needed for protocol compliance.
- Performs periodic quality assurance audits to ensure completeness and accuracy of study documents
- Collects data collection, data validation and verification through and continually monitors to assure investigates and resolves discrepancies.
- Maintains a thorough knowledge of all aspects of protocol including primary clinical aim, method of protocol execution, budgetary and logistic components and contractual requirements.
- Facilitates all audits with staff of Hackensack University Medical Center, sponsor, FDA and other regulatory agencies.
- Must continually seek and attend educational venues related to governmental regulations, research and data management.
- Identifies the needs of the patient population served and provides service that is specific to those needs (i.e. culture, language, hearing and/or visually impaired, etc.). This process includes communicating with the patient, parent and/or primary caregiver(s) at their level (developmental/age, educational, literacy, etc.).
- May be required to draw blood for sample collection.
- Adheres to the standards in the Medical Center's Organizational Competencies.
Education, Knowledge, Skills and Abilities Required:
- Bachelor's degree or equivalent work experience.
- Minimum of 1 year of clinical research/regulatory experience or equivalent.
- Mandatory education on human subject research.
- Computer proficient. Education, Knowledge, Skills and Abilities Preferred:
Licenses and Certifications Preferred:
- Association for Clinical Research Professionals Certification.
If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!
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