Job Description: CRA II

Employment Type: Full-time Work Schedule: Standard Office Hours (40/wk) Location Type: US, Remote Travel: 80%, National Travel Environmental Conditions: Office

Position Overview

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.

The CRA II performs and coordinates different aspects of the clinical monitoring and site management process. This role conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. The CRA II manages procedures and guidelines from different sponsors and/or supervising environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects' rights, well-being, and data reliability. Ensures audit readiness and develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to the role are outlined in the task matrix.

Key Responsibilities

• Site Monitoring & Compliance:
  • Monitors investigator sites with a risk-based monitoring approach.
  • Applies root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive actions.
  • Ensures data accuracy through SDR, SDV, and CRF review via on-site and remote monitoring activities.
  • Assesses investigational product through physical inventory and records review.
  • Documents observations in reports and letters in a timely manner using approved business writing standards.
  • Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution.
  • Maintains regular contact between monitoring visits with investigative sites to confirm protocol adherence, issue resolution, and timely data recording.
  • Conducts supervising tasks in accordance with the approved monitoring plan.
  • Ensures a shared responsibility with other project team members on issues/findings resolution.
  • Investigates and follows up on findings as applicable.
  • Ensures that required crucial documents are complete and in place, according to ICH-GCP and applicable regulations.
  • Conducts on-site file reviews as per project specifications.
• Site Management & Initiation:
  • Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
  • Initiates clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
  • Performs trial close-out and retrieval of trial materials.
• Communication & Reporting:
  • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
  • Ensures study systems are updated per agreed study conventions (e.g., Clinical Trial Management System).
  • Facilitates effective communication between investigative sites, the client company, and the PPD project team through written, oral, and/or electronic contacts.
• Administrative & Team Contribution:
  • Participates in the investigator payment process.
  • Participates in investigator meetings as vital.
  • Responds to company, client, and applicable regulatory requirements/audits/inspections.
  • Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.
  • Contributes to the project team by assisting in the preparation of project publications/tools, and sharing ideas/suggestions with team members.
  • Contributes to other project work and initiatives for process improvement.

Salary: Not specified Location: US, Remote