Clinical Research Associate II – FSP

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Manages all facets of study site operations to ensure patient safety is upheld, and the quality of data produced by managed sites results in consistently low query levels alongside acceptable Quality Assurance reports.

• Offers guidance at both site and project levels to meet audit readiness standards, assisting in preparation for audits and necessary follow-up actions.

• Updates, monitors, and maintains study-specific trial management tools, systems, and status reports.

• If necessary, oversees site start-up procedures, including assessing feasibility and recruiting potential investigators, preparing EC/IRB submissions, collecting and reviewing regulatory documents, adapting Patient Informed Consents, notifying IRB, EC, and regulatory authorities as appropriate, translating study-related documentation, organizing meetings, and performing other tasks as directed by the Clinical Trial Manager/Project Manager.

• If required, aids in negotiating study budgets and executing investigator contracts under the guidance of the Site Contract Management department or designee.

• Ensures that the informed consent process has been properly conducted and documented for each subject/patient, as required. Evaluates factors that may impact subject/patient safety and the integrity of clinical data at an investigator/physician site, such as protocol deviations/violations and pharmacovigilance issues.

• Independently carries out all types of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits, in compliance with the protocol, local laws, ICH-GCP, and Precision SOPs. Prepares and submits accurate and timely monitoring reports from all site visits (both on-site and remote) for review.

• Documents activities through confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents per SOPs, Clinical Monitoring Plan/Site Management Plan, and client requirements. Supports subject/patient recruitment, retention, and awareness strategies. Inputs data into tracking systems as necessary to monitor all observations, ongoing status, and assigned action items until resolved.

• Regularly reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness.

• Reconciles the contents of the ISF with the Trial Master File (TMF) and ensures that the investigator/physician site understands the need to archive essential documents in accordance with local guidelines and regulations.

• Communicates effectively and proactively with site personnel and Precision Project and Clinical Trial Management to convey protocol/study issues, including any deviations, and implements necessary actions in response to those issues.

• Cultivates and maintains strong working relationships with investigators and study staff, acting as an ambassador to promote Precision's high quality and professional image.

• Conducts investigational product (IP) inventory, reconciliation, and reviews storage and security protocols.

• Confirms that the IP has been dispensed and administered to subjects/patients in accordance with the protocol.

• Verifies any issues or risks associated with blinded or randomized information related to the IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure proper (re)labeling, importation, and release/return of the IP.

• Engages in data review activities, including remote EDC CRF and patient profile reviews, query resolution, and assists data management and clinical data quality personnel in addressing data discrepancies.

• Identifies and processes Serious Adverse Events following the procedures outlined by the study team, demonstrating a comprehensive understanding of the SAE reporting process.

• Recognizes site risks and escalates them to the Clinical Trial Manager/Project Manager with recommended contingencies. Takes ownership of the timely and appropriate resolution of risks with minimal support from the project team.

• Prepares for and participates in Investigator Meetings and/or face-to-face sponsor meetings. Engages in global clinical monitoring/project staff meetings (including Sponsor representation, as applicable) and attends clinical training sessions as dictated by project-specific requirements.

• Travels as needed based on project requirements.

• Performs other duties as assigned by management.

⛳️ Requirements

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

• Two (2) years or more of experience as a CRA in a CRO or pharmaceutical/biotech industry or equivalent relevant experience and/or demonstrated competencies. Experience in site management or equivalent experience in clinical research.

• Excellent communication and organizational skills are essential. Must be a team player.

• Experience monitoring oncology trials.

• Evidence of a client-focused approach.

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

• Ability to travel overnight, with up to 60% travel on average based on regional requirements. International travel as needed.

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

🏝️ Benefits

• Health insurance.

• Retirement savings benefits.

• Life insurance and disability benefits.

• Parental leave.

• Paid time off for sick leave and vacation.

• Discretionary annual bonus.