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Clinical Study Specialist

Green Key Resources Tarrytown, NY
  • Posted: over a month ago
  • $48 to $60 Hourly
  • Contractor
  • Benefits: Vision, Medical, Dental

Pharmaceutical Sponsor company is seeking Clinical Study Specialists to join the growing team! This person will be assigned to support the execution of one or more studies across a program including both internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs).

Job Duties:

  • 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, 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 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

Requirements:

  • Bachelor's degree and a minimum of 2+ years' industry related work experience or an advanced degree in a related field with a minimum of one (1) to two (2) years of relevant work preferred
  • 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
  • Awareness of ICH/GCP

Green Key Resources

Why Work Here?

Very friendly and helpful team in a great office environment!

Work Environment The Company is a mid-size, professional business with a national footprint providing security and fire installation and service to mid to large size organizations. The Company is approaching its 54th year in business and is a leader in the local market with several high-profile customers. The company culture is dynamic, fast-moving and growing with minimal employee turn-over.

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