Clinical Research Associate II – FSP

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervise all elements of study site management to safeguard patient safety and guarantee high-quality data.

• Provide advice on audit preparedness and assist in audit preparation and follow-up actions.

• Maintain trial-specific management tools, systems, and status reports.

• Oversee site start-up processes, including investigator feasibility and recruitment, EC/IRB submissions, regulatory document collection, informed consent review, notifications, translations, and necessary meetings.

• Assist in negotiations regarding study budgets and the execution of investigator contracts.

• Validate informed consent processes and evaluate subject safety, protocol deviations, and pharmacovigilance concerns.

• Independently carry out pre-study, qualification, initiation, routine monitoring, and close-out site visits.

• Prepare timely monitoring reports and keep confirmation letters, follow-up letters, trip reports, and communication logs up to date.

• Support subject recruitment, retention, and awareness initiatives.

• Review Investigator Site Files and ensure their reconciliation with Trial Master Files.

• Communicate protocol and study-related issues to site personnel and Precision project and clinical trial management teams.

• Maintain positive relationships with investigators and study staff.

• Manage the inventory of investigational products, including reconciliation, storage, security, dispensing, and administration verification.

• Conduct remote EDC CRF and patient profile reviews, resolve queries, and assist in data discrepancy resolution.

• Identify and manage Serious Adverse Events as per study protocols.

• Identify site risks, escalate them, and ensure timely resolution with minimal oversight.

• Attend meetings with investigators, sponsors, global monitoring, and clinical training sessions.

• Travel as required by project demands.

• Execute other tasks assigned by management.

⛳️ Requirements

• A 4-year college degree or equivalent experience in a scientific or healthcare field.

• At least two (2) years of experience as a CRA in a CRO or similar relevant position, demonstrating applicable competencies.

• Experience in site management or a similar role within clinical research.

• Exceptional communication and organizational abilities.

• A client-focused approach.

• Proficiency in using computerized information systems, electronic spreadsheets, word processing, and email.

• Willingness to travel overnight, averaging up to 60% based on regional needs.

• International travel as necessary.

• Fluency in English and, for non-English-speaking countries, proficiency in the local language of the respective country.

• A graduate or postgraduate degree is preferred.

• Experience in lupus monitoring is preferred.

• Background in monitoring rare and complex therapeutic areas is preferred.

• Familiarity with monitoring EDC trials and EHR records is preferred.

• Experience in biopharma or relevant therapeutic areas is preferred.

• Relevant experience in site start-up processes is preferred.

• Capability to monitor study sites in accordance with protocol monitoring guidelines, SOPs, GCP, and ICH guidelines is preferred.

• Ability to resolve project-related issues and prioritize tasks to meet deadlines with minimal managerial support is preferred.

• Candidates must have legal authorization to work in the country of employment without employer sponsorship.

🏝️ Benefits

• Paid time off.

• Volunteer time off.

• Comprehensive medical offerings.

• Non-vested 401(k) with company matching.

• Paid parental leave.

• Discretionary annual bonus.

• Health insurance.

• Retirement savings benefits.

• Life insurance.

• Disability benefits.

• Paid time off for sick leave and vacation.