Clinical Research Coordinator

Hackensack Meridian Health is hiring a Clinical Research Coordinator to coordinate and oversee assigned clinical trials under the general supervision of the principal investigator. The role supports compliant study conduct, research operations, participant enrollment and follow-up, regulatory documentation, and coordination with investigators, sponsors, and clinical teams.

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 participates 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 standards of behavior

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)

Human Subjects Research

Clinical Practice (GCP)

SOCRA CCRP Certification

CCRA Certification

CCRC Certification

Benefits

For full-time and part-time (20+ hours/week) job positions: health, dental, and vision benefits

For full-time and part-time (20+ hours/week) job positions: paid leave

For full-time and part-time (20+ hours/week) job positions: tuition reimbursement

For full-time and part-time (20+ hours/week) job positions: retirement benefits

Some jobs may also be eligible for performance-based incentives, bonuses, or commissions not reflected in the starting rate.

Certain positions may also be eligible for shift differentials for work performed on evening, night, or weekend shifts.

Company

Hospital network providing healthcare and medical services

Edison, New Jersey, USA

https://www.hackensackmeridianhealth.org/

Founded in 2016

10001+ employees

Qualifications

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

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)

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.

Required skills

Clinical Research, Microsoft Office, Google Suite, Human Subject Research, Clinical Practice (GCP), SOCRA-Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC)

Preferred skills

Education on human subject research and GCP

Experience

2+ years