Clinical Study Specialist

Clinical Study Specialist

Requirements

• Attention to details 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 to 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
• Bachelor’s degree with 2+ years of relevant experience or Associates Degree with 5+ years of relevant experience.

Responsibilities

• Organizes and delivers analyzable reports and metrics to the clinical study lead
• Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
• Collates data for assessments such as feasibility and site selection and reviews site usability database
• Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
• Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders)
• Collates materials for training and investigator meetings
• Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
• Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
• Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
• Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form)
• Manages and maintains team SharePoint and/or shared drive sites, as needed
• Communication with sites as directed and maintains site contact information
• Contributes to line listings review for Blind Data Review Meeting (BDRM)
• May manage or contribute to oversight of Third Party Vendors (TPV)
• Tracks and monitors close out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
• Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives
• Proactively recommends process improvement initiatives for the department
• May require 25% travel

Preferred Qualifications

• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization