Clinical Study Specialist (CSS)

• The Temp Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The individual may be assigned to support the execution of one or more studies across a program. The Temp CSS will support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs).

Responsibilities:

• Organizes and delivers analyzable reports and metrics to the Clinical Study Lead (CSL)
• Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for study team 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 (SOPs)
• Compiles study manuals including 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, enrollment 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 CSL guidance
• Ensures scheduled reports are received
• Manages and maintains team SharePoint and/or shared drive sites, as needed
• Communication with sites as directed and maintains site contact information
• Tracks and monitors close out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
• Participates in SOPs revisions or departmental initiatives
• Proactively recommends process improvement initiatives for the department

Requirements & Experience:

• You have strong attention to detail to track information and deliver on assigned study activities
• You have good communication and interpersonal skills, with an ability to build relationships internally and externally
• You can be resourceful and demonstrate problem solving skills
• You demonstrate the ability to proactively assess information and investigate the impact on clinical trials
• You are interested in acquiring further knowledge of clinical trial management activities
• You are proactive and self-disciplined, you can meet deadlines, and effectively use your time and prioritize
• To be considered for this opportunity you must possess a Bachelor’s degree and a 2+ years’ industry related work experience. An advanced degree in a related field with a minimum of one to two years of relevant work experience may be considered. You should have a familiarity with medical terms and clinical drug development, and an awareness of ICH/GCP. Up to 10% travel may be required.