Clinical Research Coordinator
Company: Hackensack Meridian Health
Posted on: August 7, 2022
Description: 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 Clinical
Research Coordinator is responsible for coordinating and overseeing
clinical operations of all assigned clinical trials and
participates in assessing, planning, implementing and compliant
study conduct according to all relevant local, federal, and state
regulatory and institutional Polices and Standard Operating
Procedures. The Clinical Research Coordinator carries out the
research and works under the general supervision of the principal
investigator responsible for the clinical trial(s) to which he/she
is assigned.Responsibilties: A day in the life of a Clinical
Research Coordinator at Hackensack Meridian Health includes: -
- Acts as liaison between principal investigators,
sub-investigators, clinical research nurses and regulatory
specialists on all regulatory issues and changes within the
- 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.
- Review 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
- 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 polices.
- Register protocol patients with appropriate statistical centers
- Track enrollment status of subjects and document dropout
information such as dropout causes and subject contact
- Act 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
- 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.
- Maintain contact with sponsors to schedule and coordinate site
visits or to answer questions about issues such as incomplete
- Ensures compliant maintenance of all required records of study
activity including case report forms, drug dispensation records, or
- Oversees and directs the requisition, collection, labeling,
storage, or shipment of specimens.
- Prepare for or participate in quality assurance audits
conducted by study sponsors, federal agencies, or specially
designated review groups.
- Prepare study-related documentation such as protocol
worksheets, procedural manuals, adverse event reports,
institutional review board documents, and progress reports.
- Identify protocol problems, inform investigators of problems,
or assist in problem resolution efforts such as protocol
- Organize space for study equipment and supplies.
- Participate in the development of study protocols including
guidelines for administration or data collection procedures.
- Contact outside health care providers and communicate with
subjects to obtain follow-up information.
- Review scientific literature, participate in continuing
education activities, or attend conferences and seminars to
maintain current knowledge of clinical studies affairs and
- Collaborate with investigators to prepare presentations or
reports of clinical study procedures, results, and
- Attends research meetings and conferences as required.
- Participates in staff meetings and in-service education of
nursing and medical staff.
- Adheres to the standards identified in the Medical Center's
Organizational Competencies.Qualifications: Education, Knowledge,
Skills and Abilities Required:
- BA/BS degree in the science/health care field or significant
equivalent related education and experience.
- Minimum 5 years of experience in the field or in a related
- Strong attention to detail and customer service focus is
- Excellent communication, organizational, presentation,
documentation, and interpersonal skills are required.
- Ability to work independently, or in a team, and handle
multiple deadline driven tasks in a dynamic environment is
- Proficiency in Microsoft Office Suite (Word, Excel, and
PowerPoint), email (Outlook), and voicemail is required.
- Review and comply with all relevant HUMC and Business Unit
policies and procedures, and local, state, and Federal laws and
regulations. - Education, Knowledge, Skills and Abilities
- Mandatory education on human subject research and GCP (CITI
Training and Certification).
- Knowledge of clinical trials and the regulation (local, state,
and federal) of such.
- Familiarity with basic scientific and healthcare principles and
- Ability to work in a fast-paced environment and manage
competing tasks and demands. -icenses and Certifications Preferred:
- Certified Clinical Research Professional or Certified Clinical
Research Associate or Certified Clinical Research Coordinator. -If
you feel that the above description speaks directly to your
strengths and capabilities, then please apply today! - -
Keywords: Hackensack Meridian Health, Irvington , Clinical Research Coordinator, Accounting, Auditing , Hackensack, New Jersey
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