Sr Clinical Research Associate

Overview

Senior Clinical Research Associate (Level I) who performs and coordinates clinical monitoring and site management activities, conducting remote or on-site visits to assess protocol and regulatory compliance and manage required documentation.

What you'll do

• Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking and problem-solving to identify site process failures and corrective/preventive actions.
• Ensure data accuracy through SDR, SDV and CRF review as applicable through 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, resolution of previously identified issues and timely data recording, as needed.
• Conduct monitoring tasks in accordance with the approved monitoring plan.
• Participate in the investigator payment process.
• Share responsibility with other project team members for issue and finding resolution, and investigate and follow up on findings as applicable.
• Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
• Ensure study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS) and perform QC checks of CTMS-generated reports where required.
• Participate in investigator meetings as necessary.
• Identify potential investigators in collaboration with the client company to ensure acceptability of qualified investigative sites.
• Initiate clinical trial sites according to relevant procedures, ensuring compliance with the protocol, regulatory and ICH GCP obligations, and make recommendations where warranted.
• Ensure trial close-out and retrieval of trial materials.
• Ensure required essential documents are complete and in place per ICH-GCP and applicable regulations, and conduct on-site file reviews per project specifications.
• Contribute to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.
• Perform additional study tasks as assigned by the CTM (e.g. trip report review, newsletter creation, lead CRA team calls).
• Facilitate effective communication between investigative sites, the client company and the project team through written, oral and/or electronic contacts.
• Respond to company, client and applicable regulatory requirements, audits and inspections.
• Maintain and complete administrative tasks such as expense reports and timesheets in a timely manner.
• Contribute to other project work and process improvement initiatives as required.

What you'll need

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent, and relevant formal academic / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years as a clinical research monitor).
• Valid driver's license where applicable.
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient.
• Effective clinical monitoring skills.
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
• Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents.
• Well-developed critical thinking skills, including critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
• Ability to manage Risk Based Monitoring concepts and processes.
• Effective oral and written communication skills, with the ability to communicate effectively with medical personnel.
• Ability to maintain customer focus through good listening skills, attention to detail and the ability to perceive customers' underlying issues.
• Effective interpersonal skills.
• Strong attention to detail.
• Effective organizational and time management skills.
• Ability to remain flexible and adaptable in a wide range of scenarios.
• Ability to work in a team or independently as required.
• Good computer skills: proficient knowledge of Microsoft Office and ability to learn appropriate software.
• Good English language and grammar skills.
• Good presentation skills.

Details

• Work schedule: Standard (Mon-Fri).
• Location: Remote, Brazil.
• Travel: frequent drives to site locations; frequent travel, generally 60-80% but more for some individuals; may include extended overnight stays.
• Work is performed in an office, laboratory, clinical and/or home office environment with exposure to electrical office equipment.
• Exposure to biological fluids with potential exposure to infectious organisms; personal protective equipment required (protective eyewear, garments and gloves).
• Exposure to fluctuating and/or extreme temperatures on rare occasions.
• Must comply with specific sponsor/client/site requirements, even if not required by Thermo Fisher Scientific (e.g., disclosure of vaccination status or other personal information), which may be provided directly to sponsor/client/site.