Clinical Study Specialist / Snr CTA - FSP - Remote

Overview

Clinical Study Specialist / Snr CTA – FSP – Remote — Parexel, Uxbridge, United Kingdom

Clinical Study Specialist / Snr CTA supports clinical study teams responsible for clinical trial execution. The CSS may be assigned to support the execution of one or more studies across a program.

Responsibilities

• Organizes and delivers 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 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 escalates 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 the Trial Master File (TMF) with guidance from the clinical study lead.

Qualifications

• Bachelor’s degree (or equivalent) and a minimum of 2+ years’ industry-related work experience or an advanced degree with 1–2 years of relevant work preferred.
• Attention to detail for tracking information and delivering on study activities.
• Good communication and interpersonal skills; ability to build relationships internally and externally.
• Ability to be resourceful and 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 Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS.
• Proactive and self-disciplined, with the ability to meet deadlines and prioritize tasks.
• Basic familiarity with medical terms and clinical drug development.
• Awareness of ICH/GCP.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Health Care Provider

Industries

• Pharmaceutical Manufacturing
• Biotechnology Research
• Hospitals and Health Care