Clinical Research Coordinator

Clinical Research Coordinator

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. This role carries out the research and works under the general supervision of the principal investigator responsible for the clinical trial(s) to which is assigned.

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.

Qualifications

Education, Knowledge, Skills and Abilities 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.

Education, Knowledge, Skills and Abilities Preferred :

• Education on human subject research and GCP.

Licenses and Certifications Preferred :

• SOCRA-Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC).

Hackensack Meridian Health