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Clinical Trials Operations Manager

2 months ago

Nutley, New Jersey, United States Hackensack Meridian Health Full time
Overview
At Hackensack Meridian Health, our team members are the foundation of our success.

We are dedicated to helping our patients lead healthier lives while fostering an environment where our employees can thrive.

Our culture emphasizes connection and collaboration, where competitive benefits are just the starting point. It's about mutual support and community engagement.

Together, we strive for continuous improvement, advancing our mission to transform healthcare and be a beacon of positive change.

The Clinical Trials Operations Manager is tasked with coordinating and supervising the clinical operations of all assigned research studies. This role is integral in assessing, planning, implementing, and ensuring compliant study conduct in accordance with all relevant local, federal, and state regulations, as well as institutional policies and standard operating procedures.

This position operates under the general oversight of the principal investigator responsible for the assigned clinical trials.

Key Responsibilities

Serves as a key point of contact between principal investigators, sub-investigators, clinical research nurses, and regulatory specialists regarding all regulatory matters and protocol modifications.

In collaboration with the principal investigator and clinical team, engages in the feasibility review of studies and assesses potential competition with other protocols prior to submission.

Works with the principal investigator and clinical research nurses to draft a budget that outlines standard care and research expenses, finalizing the budget draft with the budget coordinator.

Evaluates proposed study protocols for factors such as sample collection methods, data management strategies, and potential risks to subjects. Oversees subject enrollment to ensure informed consent is properly obtained and documented.

Coordinates research activities, including scheduling laboratory tests, radiology exams, and other medical assessments as required.

Collaborates with the study team to create study-specific orders, billing templates, and calendars as necessary.

Schedules subjects for appointments, procedures, or inpatient stays as dictated by study protocols.

Monitors all study activities to ensure adherence to protocols and compliance with all relevant regulations and institutional policies.

Registers protocol patients with the appropriate statistical centers as required and tracks enrollment status, documenting dropout information and contact efforts.

Acts as the representative of the principal investigator when appropriate, which may involve communication with sponsors, IRB, and other medical personnel.

Maintains accurate, complete, and up-to-date records for each protocol and patient involved in clinical trials within the clinical trial management system and other required systems.

Works closely with clinical research finance to ensure that clinical trial-related activities for study patients are billed correctly.

Schedules, coordinates, prepares, and assists in all sponsor monitor site visits, ensuring that all supporting documentation is complete and available; meets with the monitor at least once during each visit to resolve any issues.

Maintains communication with sponsors to schedule site visits or address questions regarding incomplete data.

Ensures compliant maintenance of all required study activity records, including case report forms, drug dispensation records, and regulatory forms.

Oversees the requisition, collection, labeling, storage, or shipment of specimens.

Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or 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 issues, informs investigators, and assists in resolving problems, including 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 external healthcare providers and communicates with subjects to obtain follow-up information.

Stays informed by reviewing scientific literature, participating in continuing education, and attending conferences and seminars related to clinical studies.

Collaborates with investigators to prepare presentations or reports detailing clinical study procedures, results, and conclusions.

Attends research meetings and conferences as required and 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

BA/BS degree in a science or healthcare field.

A minimum of 2 years of experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years of related experience in clinical research.

Strong attention to detail and a focus on customer service.

Ability to work independently or as part of a team, managing multiple deadline-driven tasks in a dynamic environment.

Excellent organizational, presentation, documentation, and interpersonal skills.

Strong written and verbal communication skills.

Proficient in computer skills, including Microsoft Office and/or Google Suite platforms.

Preferred Qualifications:
Education in 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).