JFK Johnson Rehabilitation Institute · 2 hours ago
CLINICAL RESEARCH COORDINATOR
Hackensack, NJ
Full-time
Onsite
Mid, Senior Level
2+ years expHackensack Meridian Health is committed to transforming healthcare and serving as a leader of positive change. The Clinical Research Coordinator is responsible for coordinating and overseeing clinical operations of clinical trials, ensuring compliance with regulations and protocols while supporting the principal investigator.
Hospital & Health Care
Responsibilities
Acts as liaison between principal investigators, sub-investigators, clinical research nurses and regulatory specialists on all regulatory issues and changes within the protocol
In collaboration with the principal investigator, clinical research coordinator, and clinical team, participates in the review of studies for feasibility and evaluates potential competition with other protocols prior to submitting study
Reviews study with principal investigator and/or clinical research nurses to a budget outlining standard of care and research costs. Finalizes budget draft with budget coordinator
Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks. Oversee subject enrollment to ensure that informed consent is properly obtained and documented
Coordinates research activities not limited to: scheduling laboratory tests, radiology testing and other medical exams as required
Works with the study team to draft/create study specific study orders, billing templates and study calendars as necessary
Schedules subjects for appointments, procedures, or inpatient stays as required by study protocols
Monitors all study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies
Registers protocol patients with appropriate statistical centers as required
Tracks enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts
Acts as principal investigator's representative as appropriate. This may include communicating with sponsors and their representatives, the IRB and other medical personnel
Along with clinical research nurses, maintains accurate, complete, up-to-date records on each protocol and each patient participating in a clinical trial protocol in the clinical trial management system and all other systems as required
Works closely with clinical research finance to ensure study patient's clinical trial related activities are billed appropriately
Schedules, coordinates, prepares, and assists for all sponsor monitor site visits and ensures all supporting documentation records are adequate and available for the visit; Meets with monitor at least once during each monitor site visit and resolves all issues found during visit
Maintains contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data
Ensures compliant maintenance of all required records of study activity including case report forms, drug dispensation records, or regulatory forms
Oversees and directs the requisition, collection, labeling, storage, or shipment of specimens
Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups
Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports
Identifies protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions
Organizes space for study equipment and supplies
Participates in the development of study protocols including guidelines for administration or data collection procedures
Contacts outside health care providers and communicate with subjects to obtain follow-up information
Reviews scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues
Collaborates with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions
Attends research meetings and conferences as required
Participates in staff meetings and in-service education as necessary
Other duties and/or projects as assigned
Adheres to HMH Organizational competencies and standard of behavior
Qualification
Required
BA/BS diploma/degree in science or healthcare field
Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in the field of clinical research
Strong attention to detail and customer service focus
Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential
Excellent organizational, presentation, documentation and interpersonal skills
Excellent written and verbal communication skills
Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms
Preferred
Education on human subject research and GCP
SOCRA-Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC)
Benefits
Health
Dental
Vision
Paid leave
Tuition reimbursement
Retirement benefits
Company
JFK Johnson Rehabilitation Institute
Offering New Jersey’s most comprehensive rehabilitation services, JFK Johnson Rehabilitation Institute is a 94-bed facility located in Edison, NJ, serving residents of the tristate area for more than 40 years.
10001+ employees
Funding
Current Stage
Late StageCompany data provided by crunchbase