FSP Clinical Research Associate - Oncology

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 different 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). Acting as a site process 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.

What You’ll Do

• Monitor investigator sites with a risk-based monitoring approach: apply root cause analysis, critical thinking, and problem-solving skills to identify site process failures and corrective/preventive actions to bring the site into compliance and decrease risks.
• Ensure data accuracy through source data review (SDR), source data verification (SDV), and CRF review as applicable during on-site and remote monitoring activities.
• Assess investigational product through physical inventory and records review. Document observations in reports and letters in a timely manner using approved business writing standards.
• Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. Maintain regular contact between monitoring visits with investigative sites to confirm protocol adherence, issue resolution, and timely data recording.
• Conduct monitoring tasks in accordance with the approved monitoring plan. Participate in the investigator payment process. Ensure shared responsibility with other project team members on issues/findings resolution.
• Investigate and follow up on findings as applicable. Participate in investigator meetings as necessary. Identify potential investigators in collaboration with the client company to ensure qualified investigative sites.
• Initiate clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory and ICH-GCP obligations, making recommendations where warranted. Perform trial closeout and retrieval of trial materials.
• Ensure that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conduct on-site file reviews as per project specifications.
• Provide trial status tracking and progress update reports to the team as required. Ensure study systems are complete, accurate, and updated per agreed study conventions (e.g., Clinical Trial Management System).
• Facilitate effective communication between investigative sites, the client company, and internal project teams through written, oral, and/or electronic contacts. Respond to company, client, and applicable regulatory requirements/audits/inspections.
• Maintain and complete administrative tasks such as expense reports and timesheets in a timely manner.
• Contribute to the project team by assisting in the preparation of project publications/tools and sharing ideas with team members. Contribute to other project work and initiatives for process improvement, as required.

Education and Experience Requirements

• Bachelor's degree in a life sciences-related field or a Registered Nursing certification or equivalent, with relevant formal academic/vocational qualification.
• Minimal clinical monitoring experience providing the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research, health care, or 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, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience may be considered sufficient for the role.

Knowledge, Skills and Abilities

• Basic medical/therapeutic area knowledge and understanding of medical terminology.
• Ability to attain and maintain working knowledge of ICH GCPs and applicable regulations and procedural documents.
• Good oral and written communication skills with the ability to communicate effectively with medical personnel.
• Good interpersonal skills.
• Ability to maintain customer focus through active listening, attention to detail, and understanding customers’ underlying issues.
• Good organizational and time management skills.
• Flexibility and adaptability in a wide range of scenarios.
• Well-developed critical thinking skills, including root cause analysis and problem solving.
• Ability to manage Risk-Based Monitoring concepts and processes.
• Ability to work in a team or independently as required.
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software.
• Good English language and grammar skills.

Working Conditions and Environment

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