CRA I/CRA II/Sr CRA

Work Schedule: Standard (Mon-Fri)

Environmental Conditions: Office

Job Description

Join Us as a Clinical Research Associate I – Make an Impact at the Forefront of Innovation. We have supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll perform and coordinate various aspects of the clinical monitoring and site management process. You will conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (e.g., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure 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. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities are outlined in the task matrix.

Responsibilities

• Monitor investigator sites with a risk-based monitoring approach; apply root cause analysis, critical thinking, and problem-solving to identify site process failures and implement corrective/preventive actions to achieve compliance and reduce risk.
• Ensure data accuracy through source data verification (SDV) and database review as applicable during on-site and remote monitoring; assess investigational product through physical inventory and records review.
• Document observations in reports and letters using approved business writing standards; escalate deficiencies and issues to clinical management and follow through to resolution.
• Maintain regular contact with investigative sites between monitoring visits to ensure protocol adherence, issue resolution, and timely data recording.
• Conduct monitoring tasks in accordance with the approved monitoring plan; participate in the investigator payment process; collaborate with team members on issues and findings.
• Investigate and follow up on findings as applicable; participate in investigator meetings as necessary.
• Assist in identifying potential investigators in collaboration with the client company to ensure qualified investigative sites; initiate clinical trial sites according to procedures to ensure protocol compliance and regulatory/ICH GCP obligations; provide recommendations when warranted.
• Perform trial closeout and retrieval of trial materials; ensure essential documents are complete and in place per ICH-GCP and applicable regulations; conduct on-site file reviews per project specifications.
• Provide trial status tracking and progress updates to the team; ensure study systems are complete, accurate, and updated per study conventions (e.g., Clinical Trial Management System).
• Facilitate effective communication between investigative sites, the client company, and internal project teams; respond to regulatory requirements, audits, and inspections.
• Complete administrative tasks such as expense reports and timesheets in a timely manner.
• Contribute to project work by preparing project publications/tools and sharing ideas for process improvement; support other project initiatives as required.

Education and Experience

• Bachelor's degree in a life sciences field or a registered nursing certification or equivalent and relevant formal qualification.
• Minimal clinical monitoring experience (comparable to 2 years) in a clinical environment involving clinical trials, medical terminology, medical research, or health care; or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
• Valid driver’s license where applicable. In some cases, equivalency comprising a combination of education, training, and/or related experience may suffice.

Knowledge, Skills and Abilities

• Basic medical/therapeutic area knowledge and medical terminology.
• Ability to attain and maintain working knowledge of ICH-GCPs and applicable regulations.
• Strong oral and written communication skills, with the ability to effectively interact with medical personnel.
• Good interpersonal skills; customer-focused with attentive listening and attention to detail.
• Strong organizational and time management abilities; flexible and adaptable to various scenarios.
• Critical thinking, in-depth investigation, root cause analysis, and problem-solving capabilities.
• Knowledge of Risk Based Monitoring concepts and processes; ability to work independently or in a team.
• Proficiency with Microsoft Office and the ability to learn relevant software; good English language and grammar skills.

Working Conditions

• Work is performed in an office, laboratory, clinical, and/or home-office environment with exposure to electrical equipment.
• Frequent travel to site locations; travel is generally 60-80%, with potential for extended overnight stays.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Personal protective equipment may be required, including protective eyewear, garments, and gloves.
• Occasional exposure to fluctuating and/or extreme temperatures.