Hackensack Meridian Health Research Coordinator in Hackensack, New Jersey
David_Alice Jurist Institute
Hackensack University Med Cntr
Full Time with Benefits
Standard Hours Per Week
8:30am - 5pm
No Weekends Required
On Call Work
No On-Call Required
No Holidays Required
How have you impacted someone's life today? At Hackensack Meridian Health our teams are focused on changing the lives of our patients by providing the highest level of care each and every day. From our hospitals, rehab centers and occupational health teams to our long-term care centers and at-home care capabilities, our complete spectrum of services will allow you to apply your skills in multiple settings while building your career, all within New Jersey's premier healthcare system.
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.
A day in the life of Postdoctoral 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.
Minimum of 1 year of clinical research/regulatory experience or equivalent.
Mandatory education on human subject research.
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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Meridian Health is committed to the principles of equal employment opportunity and affirmative action and will not discriminate in the recruitment or employment practices on the basis of race, color, creed, national origin, ancestry, marital status, gender, age, religion, sexual orientation, gender identity/expression, disability, veteran status and any other category protected by federal or state law.