Proclinical Staffing
Clinical Study Specialist - Contract - Basking Ridge, NJ
Proclinical is seeking a Clinical Study Specialist to provide technical and administrative support to clinical study teams responsible for executing clinical trials. This position requires onsite presence and is not fully remote.
Primary Responsibilities The successful candidate will play a key role in supporting one or more studies within a program, working closely with the Clinical Study Lead or Clinical Study Associate Manager.
Skills & Requirements
Strong attention to detail and ability to track and manage information effectively.
Excellent communication and interpersonal skills to build relationships internally and externally.
Resourceful with strong problem-solving abilities.
Ability to assess information proactively and understand its impact on clinical trials.
Proficiency in trial management systems and MS applications (e.g., Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF).
Self-disciplined with effective time management and prioritization skills.
Basic familiarity with medical terminology and clinical drug development processes.
Awareness of ICH-GCP guidelines.
Bachelor's degree with relevant experience in clinical operations or related fields.
Clinical Study Specialist Responsibilities
Organize and deliver reports and metrics to the clinical study lead.
Schedule and coordinate meetings, prepare agendas, presentation materials, and minutes for study-related meetings.
Collate data for feasibility assessments, site selection, and review site usability databases.
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, ensuring proper version control.
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 reconciliations of the Trial Master File (TMF) under guidance.
Ensure timely receipt of scheduled reports, such as 1572 reportable changes and financial disclosure forms.
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 (TPV).
Track and monitor study close-out activities, including documentation and reconciliation processes.
Participate in Standard Operating Procedures (SOPs) revisions or departmental initiatives.
Proactively recommend process improvements for the department.
Travel up to 25% may be required.
Compensation $50.00 - $60.00
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Primary Responsibilities The successful candidate will play a key role in supporting one or more studies within a program, working closely with the Clinical Study Lead or Clinical Study Associate Manager.
Skills & Requirements
Strong attention to detail and ability to track and manage information effectively.
Excellent communication and interpersonal skills to build relationships internally and externally.
Resourceful with strong problem-solving abilities.
Ability to assess information proactively and understand its impact on clinical trials.
Proficiency in trial management systems and MS applications (e.g., Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF).
Self-disciplined with effective time management and prioritization skills.
Basic familiarity with medical terminology and clinical drug development processes.
Awareness of ICH-GCP guidelines.
Bachelor's degree with relevant experience in clinical operations or related fields.
Clinical Study Specialist Responsibilities
Organize and deliver reports and metrics to the clinical study lead.
Schedule and coordinate meetings, prepare agendas, presentation materials, and minutes for study-related meetings.
Collate data for feasibility assessments, site selection, and review site usability databases.
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, ensuring proper version control.
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 reconciliations of the Trial Master File (TMF) under guidance.
Ensure timely receipt of scheduled reports, such as 1572 reportable changes and financial disclosure forms.
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 (TPV).
Track and monitor study close-out activities, including documentation and reconciliation processes.
Participate in Standard Operating Procedures (SOPs) revisions or departmental initiatives.
Proactively recommend process improvements for the department.
Travel up to 25% may be required.
Compensation $50.00 - $60.00
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