FSP Sr Clinical Research Associate

Overview

Performs and coordinates clinical monitoring and site management activities, conducting remote or on-site visits to assess protocol and regulatory compliance while acting as a site processes specialist.

What you'll do

• Monitor investigator sites using a risk-based monitoring approach.
• Apply root cause analysis, critical thinking and problem-solving to identify site process failures and corrective/preventive actions.
• Ensure data accuracy through SDR, SDV and CRF review during on-site and remote monitoring.
• 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 and follow all issues through to resolution.
• Maintain regular contact between monitoring visits to confirm protocol adherence, resolution of prior 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 findings resolution.
• Investigate and follow up on findings as applicable.
• Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
• Update study systems per agreed study conventions (e.g. 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 sites.
• Initiate clinical trial sites according to relevant procedures, making 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.
• Conduct on-site file reviews as per project specifications.
• Contribute to project publications/tools and share ideas 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.
• Respond to company, client and regulatory requirements, audits and inspections.
• 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 providing the knowledge, skills and abilities to perform the job (comparable to 2+ years as a clinical research monitor).
• Valid driver's license where applicable.
• 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 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.
• Customer focus through good listening skills, attention to detail and 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: solid knowledge of Microsoft Office and ability to learn appropriate software.
• Good English language and grammar skills.
• Good presentation skills.

Details

• Work schedule: standard Monday to Friday.
• Location: Remote, Brazil.
• Travel requirement: more than 75%.
• In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience will be considered.