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Clinical Study Specialist
4 months ago
Company Introduction
Cpl Life Science is partnering with a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Known for its robust pipeline of innovative therapies and commitment to scientific excellence, the company has been recognized globally for its contributions to medicine and healthcare. The company focuses on the discovery, development, and commercialization of medicines for conditions such as ophthalmology, oncology, and rare diseases, leveraging its proprietary technologies.
Role Overview:
As a Clinical Study Specialist (CSS) you will provide vital technical and administrative support to the clinical study teams, aiding in the execution of clinical trials. This position involves organizing, managing, and tracking key aspects of clinical studies, including Trial Master File (TMF) performance, scheduling, and reporting. The CSS will collaborate closely with Clinical Study Leads and Clinical Study Associate Managers, contributing to both internally sourced and outsourced studies.
*This role requires onsite presence for three days a week near the Armonk, NY or Basking Ridge, NJ greater areas.*
Key Responsibilities:
- Data and Reporting: Organize and deliver detailed reports and metrics to the clinical study lead. Perform scheduled reconciliations of the Trial Master File (TMF) and ensure compliance with clinical study protocols. (i.e.,1572 reportable changes, financial disclosure form)
- Tracks and monitors close out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
- Contributes to line listings review for Blind Data Review Meeting (BDRM)
- Meeting Coordination: Schedule and coordinate meetings, prepare agendas, and presentation materials for clinical study team meetings, and other study-related gatherings.
- Document Management: Assist 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 Materials Preparation: Collate materials for training and investigator meetings and support the creation of study reference binders and manuals. (e.g., regulatory, pharmacy, and laboratory binders
- Site and Vendor Management: Track site activation, enrollment, and monitoring visits. Communicate with study sites, update investigator/site statuses, and support clinical trial registry postings. May manage or contribute to oversight of Third-Party Vendors (TPV)
- Process Improvement: Participate in the revision of Standard Operating Procedures (SOPs) and departmental initiatives. Proactively recommend process improvements for greater efficiency.
Requirements:
- Detail-Oriented: Strong attention to detail is essential for tracking information and ensuring the accuracy of study activities.
- Communication Skills: Excellent communication and interpersonal skills to build relationships both internally and externally.
- Problem-Solving: Resourcefulness and problem-solving abilities to proactively address issues impacting clinical trials.
- Educational and Experience Requirements: A Bachelor’s degree with 2+ years of relevant pharmaceutical industry experience, or in lieu of a degree, 5+ years of experience with a focus on clinical operations or trial management.
- Travel Requirement: Up to 25% travel may be required.
Compensation: The position offers a competitive salary range of $110,000 to $125,000 on a 12-month contract basis. ~ 55/HR - 62.5/HR
Work Environment: This role is hybrid, requiring onsite work for three days a week near the surround areas of Armonk, NY, or Basking Ridge, NJ. Fully remote work is not possible for this position.
Join the team and contribute to groundbreaking research and the development of innovative therapies that make a real difference in patients’ lives. If you meet the qualifications and are passionate about clinical research, we encourage you to apply.
