Clinical Research Coordinator

2 weeks ago

Basking Ridge, New Jersey, United States Cpl Life Sciences US Full time

Company Overview

Cpl Life Science collaborates with a prominent biotechnology firm dedicated to developing transformative medications for individuals facing severe health challenges. Renowned for its extensive pipeline of pioneering therapies and dedication to scientific integrity, this organization has gained international recognition for its significant contributions to healthcare and medicine. The focus lies on the discovery, development, and commercialization of treatments for various conditions, including ophthalmology, oncology, and rare diseases, utilizing proprietary technologies.

Position Summary:

As a Clinical Study Specialist (CSS), you will play a crucial role in providing essential technical and administrative assistance to clinical study teams, facilitating the smooth execution of clinical trials. This role encompasses the organization, management, and monitoring of critical components of clinical studies, such as Trial Master File (TMF) performance, scheduling, and reporting. The CSS will work closely with Clinical Study Leads and Clinical Study Associate Managers, contributing to both internally managed and outsourced studies.

Key Responsibilities:

  • Data Management and Reporting: Organize and deliver comprehensive reports and metrics to the clinical study lead. Conduct scheduled reconciliations of the Trial Master File (TMF) and ensure adherence to clinical study protocols.
  • Monitor and track close-out activities, including study close-out documents and CRA close-out visits.
  • Assist in the review of line listings for Blind Data Review Meetings (BDRM).
  • Meeting Coordination: Schedule and organize meetings, prepare agendas, and create presentation materials for clinical study team meetings and related gatherings.
  • Document Oversight: Aid in the review and compilation of study documents, such as informed consent forms, case report forms, and study manuals. Maintain version control of study reference materials.
  • Training and Resource Preparation: Gather materials for training and investigator meetings and support the development of study reference binders and manuals.
  • Site and Vendor Coordination: Track site activation, enrollment, and monitoring visits. Communicate with study sites, update investigator/site statuses, and assist with clinical trial registry postings.
  • Process Enhancement: Engage in the revision of Standard Operating Procedures (SOPs) and departmental initiatives. Proactively suggest process improvements for enhanced efficiency.

Qualifications:

  • Attention to Detail: Exceptional attention to detail is critical for tracking information and ensuring the accuracy of study activities.
  • Communication Proficiency: Strong communication and interpersonal skills to foster relationships both internally and externally.
  • Analytical Skills: Resourcefulness and problem-solving capabilities to proactively address challenges affecting clinical trials.
  • Educational Background: A Bachelor's degree with 2+ years of relevant experience in the pharmaceutical industry, or alternatively, 5+ years of experience focusing on clinical operations or trial management.
  • Travel Expectation: Up to 25% travel may be necessary.

Compensation: This position offers a competitive salary range of $110,000 to $125,000 on a 12-month contract basis.

Work Environment: This role is hybrid, requiring onsite work for three days a week. Fully remote work is not an option for this position.

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