Clinical Research Associate

Position Overview

The Clinical Research Associate (CRA) will monitor investigator sites using a risk-based monitoring approach. This role involves applying root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive actions to ensure compliance and mitigate risks. The CRA will ensure data accuracy through Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) review, utilizing both on-site and remote monitoring activities.

Responsibilities

• Site Monitoring:
  • Monitors investigator sites with a risk-based monitoring approach.
  • Applies root cause analysis (RCA), critical thinking, and problem-solving skills to identify site processes failures and corrective/preventive actions.
  • Ensures data accuracy through SDR, SDV, and CRF review as applicable through 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, resolution of identified issues, and timely data recording.
  • Conducts monitoring tasks in accordance with the approved monitoring plan.
  • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
  • Conducts on-site file reviews as per project specifications.
• Study Management & Support:
  • Participates in the investigator payment process.
  • Ensures shared responsibility with other project team members on issues/findings resolution.
  • Investigates and follows-up on findings as applicable.
  • 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, CTMS).
  • Performs QC checks of reports generated from the CTMS system where required.
  • Participates in investigator meetings as necessary.
  • 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.
  • Ensures trial close out and retrieval of trial materials.
• Team Collaboration & Communication:
  • Contributes to the project team by assisting in the preparation of project publications/tools, and sharing ideas/suggestions with team members.
  • Performs additional study tasks as assigned by CTM (e.g., trip report review, newsletter creation, lead CRA team calls, etc.).
  • Facilitates effective communication between investigative sites, the client company, and the PPD project team through written, oral, and/or electronic contacts.
• Compliance & Administration:
  • 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 other project work and initiatives for process improvement, as required.

Employment Type

• Full time

Work Schedule

• Standard (Mon-Fri)

Environmental Conditions

• Office

Salary

• Not specified

Location Type

• Not specified