FSP Clinical Research Associate I

Overview

Performs and coordinates clinical monitoring and site management activities, conducting remote or on-site visits to assess protocol and regulatory compliance and managing required documentation.

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/preventative actions to bring sites into compliance and decrease risks.
• Ensure data accuracy through Source Data Review (SDR), Source Data Verification (SDV) and Case Report Form (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 promptly and follow all issues through to resolution.
• Maintain regular contact between monitoring visits with investigative sites to confirm protocol adherence, resolution of identified issues and timely data recording, as applicable.
• 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.
• Investigate and follow up on findings as applicable.
• Participate in investigator meetings as necessary.
• Help identify potential investigators in collaboration with the client company to ensure acceptability of qualified investigative sites, as applicable.
• Initiate clinical trial sites according to relevant procedures to ensure compliance with the protocol, regulatory and ICH GCP obligations, making recommendations where warranted.
• Perform trial close-out and retrieval of trial materials.
• Ensure 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, such as the Clinical Trial Management System (CTMS), are complete, accurate and updated per agreed study conventions.
• 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 and inspections.
• Maintain and complete administrative tasks such as expense reports and timesheets in a timely manner.
• Contribute to the project team by assisting in preparation of project publications and tools and sharing ideas and suggestions.
• 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 or vocational qualification.
• Minimal clinical monitoring experience comparable to 2 years in a clinical environment, gained in clinical trials, medical terminology, medical research, clinical research or health care; experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
• Valid driver's license where applicable.
• Basic medical/therapeutic area knowledge and understanding of medical terminology.
• Ability to attain and maintain a 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 good listening skills, attention to detail and the ability to perceive customers' underlying issues.
• Good organizational and time management skills.
• Ability to remain flexible and adaptable in a wide range of scenarios.
• 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.
• Ability to work in a team or independently as required.
• Good computer skills, with solid knowledge of Microsoft Office and the ability to learn appropriate software.
• Good English language and grammar skills.

Details

• Work schedule: standard, Monday to Friday.
• Location: Remote, Brazil.
• Travel requirement: more than 75%.