Job Description

Clinical Study Specialist - Oncology - Contract - Basking Ridge, NJ

Are you a dedicated individual looking to put your expertise to work in a more flexible hybrid working position?

Proclinical is seeking a Clinical Study Specialist to provide technical and administrative support for clinical study teams involved in trial execution.

Primary Responsibilities:

In this role, you will contribute to the successful management of clinical trials, supporting both internally sourced studies and those outsourced to Clinical Research Organizations (CROs). This hybrid position offers an opportunity to work collaboratively with cross-functional teams in a dynamic environment.

Skills & Requirements:

• Strong attention to detail with the ability to track and manage study activities effectively.
• Excellent communication and interpersonal skills to build relationships internally and externally.
• Resourceful problem-solving abilities and proactive assessment of information.
• Experience in clinical operations or trial management, with a focus on oncology.
• Bachelor's degree preferred; equivalent experience in the pharmaceutical industry will be considered.

The Clinical Study Specialist's responsibilities will be:

• Organize and deliver reports and metrics to the clinical study lead.
• Schedule and coordinate meetings, prepare agendas, presentation materials, and minutes for study-related discussions.
• Collate data for feasibility assessments, site selection, and database reviews.
• Contribute to the review of study documents, including informed consent forms and case report forms, ensuring compliance with standard operating procedures.
• Compile and maintain study manuals and reference materials, such as regulatory, pharmacy, and laboratory binders.
• Prepare materials for training sessions and investigator meetings.
• Track site activation, enrollment, and monitoring visits, escalating issues or delays as needed.
• Monitor and update investigator-site status and support clinical trial registry postings.
• Perform scheduled reconciliations of the Trial Master File (TMF) under guidance.
• Ensure timely receipt of required reports, such as 1572 forms and financial disclosures.
• Manage and maintain team SharePoint or shared drive sites.
• Communicate with sites as directed and maintain accurate site contact information.
• Contribute to line listings review for Blind Data Review Meetings (BDRM).
• Oversee or assist in managing third-party vendors (TPVs).
• Track and monitor study close-out activities, including document reconciliation and CRA close-out visits.
• Participate in SOP revisions and departmental initiatives.
• Proactively recommend process improvements to enhance efficiency.

Compensation:

• $45 to $57 per hour.

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at [email protected]

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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