Job Description

Clinical Trial Specialist - Contract - Basking ridge, NJ

Proclinical is looking for a Clinical Trial Specialist to provide technical and administrative support to the clinical study team(s) responsible for clinical trial execution. This is a hybrid role.

Primary Responsibilities:

The successful candidate may be assigned to support the execution of one or more studies across a program. The CTS receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CTS will support internally sourced studies and studies outsourced to Clinical Research Organizations (CROs).

Skills & Requirements:

• Attention to detail for the ability to track information and deliver on assigned study activities
• Good communication and interpersonal skills; ability to build relationships internally and externally
• Ability to be resourceful and demonstrate problem-solving skills
• Demonstrate the ability to proactively assess information and investigate impact on clinical trials
• Ability to acquire working knowledge in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
• Basic familiarity with medical terms and clinical drug development
• Awareness of ICH/GCP

The Clinical Trial Specialist's responsibilities will be:

• Organizing and delivering analyzable reports and metrics to the clinical study lead
• Scheduling and coordinating meetings, preparing agendas, presentation materials, and minutes for clinical study team meetings and other study-related meetings
• Collating data for assessments such as feasibility and site selection and reviewing site usability database
• Contributing to the review of study documents such as informed consent forms, case report forms, and facilitating study document reviews per company standard operating procedures
• Compiling study manuals including but not limited to study reference binders and manuals and maintaining versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders)
• Collating materials for training and investigator meetings
• Tracking site activation, enrollment, and monitoring visits to projected plans, and escalating any issues or delays with site activation or deviations from the monitoring plan
• Monitoring and updating investigator/site status for the trial, and supporting clinical trial registry postings
• Performing scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
• Ensuring scheduled reports are received (i.e., 1572 reportable changes, financial disclosure form)
• Managing and maintaining team SharePoint and/or shared drive sites, as needed
• Communicating with sites as directed and maintaining site contact information
• Contributing to line listings review for Blind Data Review Meeting (BDRM)
• Managing or contributing to oversight of Third Party Vendors (TPV)
• Tracking and monitoring close-out activities - study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
• Participating in Standard Operating Procedures (SOPs) revisions or departmental initiatives
• Proactively recommending process improvement initiatives for the department
• May require 25% travel

If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at b.forsen@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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