Clinical Research Associate II – FSP

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

📋 Description

• Manage all facets of study site oversight to ensure patient safety and maintain high-quality data along with satisfactory Quality Assurance reports.

• Provide site and project-level guidance to enhance audit readiness and assist with audit preparation and follow-up actions.

• Update, monitor, and manage study-specific trial management tools, systems, and status reports.

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

• Assist with the negotiation of study budgets and execution of investigator contracts when required.

• Verify the processes and documentation related to informed consent; evaluate risks concerning subject safety and clinical data integrity.

• Conduct pre-study/qualification, initiation, routine monitoring, and close-out visits independently, adhering to protocols, local laws, ICH-GCP guidelines, and Precision SOPs.

• Prepare timely monitoring reports for both on-site and remote visits.

• Document activities through confirmation letters, follow-up letters, trip reports, communication logs, and other necessary project documents.

• Aid in strategies for subject/patient recruitment, retention, and awareness.

• Input observations, status updates, and action items into tracking systems and drive them to resolution.

• Review Investigator Site Files for accuracy, timeliness, and completeness, reconciling them with Trial Master Files.

• Ensure that investigator sites comprehend essential-document archiving requirements.

• Communicate protocol and study-related issues with site personnel, as well as with Precision Project and Clinical Trial Management.

• Foster relationships with investigators and study staff, representing Precision's commitment to quality and professionalism.

• Conduct inventory, reconciliation, storage, and security reviews of investigational products.

• Confirm the dispensing and administration of investigational products, managing related blinded/randomized information and regulatory procedures.

• Perform remote EDC CRF and patient-profile data reviews, resolve queries, and assist in the resolution of data discrepancies.

• Identify and process Serious Adverse Events per study protocols.

• Recognize site risks, escalate them with suggested contingencies, and ensure timely resolutions.

• Attend Investigator Meetings, sponsor meetings, global monitoring/project meetings, and required clinical training sessions.

• Travel as necessary based on project demands.

• Carry out additional responsibilities as assigned by management.

⛳️ Requirements

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

• A minimum of two (2) years as a CRA in a CRO or equivalent relevant experience and/or demonstrated competencies.

• Experience in site management or equivalent clinical research experience.

• Strong communication and organizational skills.

• A collaborative team player.

• Client-focused mindset.

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

• Willingness to travel overnight.

• An average of up to 60% travel based on regional needs; international travel as required.

• Fluency in English and, for non-English speaking countries, proficiency in the local language where the position is based.

• Candidates must be legally authorized to work in the country of employment without employer sponsorship.

🏝️ Benefits

• Discretionary annual bonus.

• Health insurance coverage.

• Retirement savings benefits.

• Life insurance provisions.

• Disability benefits.

• Paid parental leave.

• Paid time off for sick leave and vacation.

• Volunteer time off.

• Comprehensive medical offerings.

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

• Support for professional growth.

• Reasonable travel and work/life balance.