kps life · 1 week ago
Clinical Study Specialist (Warren, NJ, Cambridge, MA or Armonk/Tarrytown, NY)
Warren, NJ
Full-time
Hybrid
Entry, Mid Level
2+ years expKPS Life is looking for a Clinical Study Specialist to join their clinical development team dedicated to a sponsor partner. The role involves providing technical and administrative support for clinical trial execution, organizing meetings, compiling study materials, and tracking site activities.
Health CareMedicalWellness
Hiring Manager
Lorena Paolillo (Certified Sr. Recruiter)
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
Supports receipt of scheduled reports (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
Proactively recommends process improvement initiatives for the department
May require 25% travel
Qualification
Required
Bachelor's degree (or equivalent) 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
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
Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS
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
Company
kps life
KPS Life is a functional service solution that improves efficiency, lowers trial costs, and gives the sponsor strategic control.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$3.5M2025-06-11Undisclosed· $3.5M
2021-02-26Debt Financing
2021-01-12Private Equity
Leadership Team
Kevin Duffy
Chief Commercial Officer
Recent News
2023-06-05
Company data provided by crunchbase