FSP Sr Clinical Research Associate

Overview

Performs and coordinates all aspects of the clinical monitoring and site management process, conducting remote or on-site visits to assess protocol and regulatory compliance and managing required documentation.

What you'll do

• Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation.
• Manage procedures and guidelines from different sponsors and/or monitoring environments (e.g. FSO, FSP, Government).
• Act as a site processes specialist, ensuring the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subject rights, well-being and data reliability.
• Ensure audit readiness.
• Develop collaborative relationships with investigational sites.
• Monitor investigator sites with a risk-based monitoring approach.
• Apply root cause analysis (RCA), 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 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 as needed to confirm protocol adherence, resolution of previously identified issues and timely data recording.
• Conduct monitoring tasks in accordance with the approved monitoring plan.
• Participate in the investigator payment process.
• Share responsibility with other project team members on issues/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.
• Ensure study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS) and perform QC check 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 to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
• Ensure 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.
• 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 CTM (e.g. trip report review, newsletter creation, lead CRA team calls).
• Facilitate effective communication between investigative sites, the client company and the PPD project team 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 other project work and initiatives for process improvement, 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 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 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: solid knowledge of Microsoft Office and the ability to learn appropriate software.
• Good English language and grammar skills.
• Good presentation skills.

Details

• Location: Remote, Argentina.
• Work schedule: Standard (Mon-Fri), office job description.
• Travel requirement: more than 75%.