Clinical Research Associate II - FSP

This remote role requires a resident of Texas or California. Position Summary The CRA II is a seasoned, experienced professional in monitoring and site management. Responsibilities will vary with the type and timing of the program to which the CRA II is assigned and typically include start‑up and study implementation, on‑site monitoring of clinical research studies, and ongoing site management. Incumbents work independently as a study team member. Essential Functions Oversee all aspects of study site management to ensure patient safety and high‑quality data, resulting in consistently low query levels and acceptable Quality Assurance reports. Provide guidance at the site and project level toward audit readiness standards and support preparation for audit and required follow‑up actions. Update, track and maintain study‑specific trial management tools/systems and status reports. When required, manage site start‑up procedures including feasibility, recruitment of investigators, EC/IRB submissions, regulatory document review, consent adaptation, notifications to authorities, translation of study documents, and organization of meetings. Assist in negotiating study budgets and executing investigator contracts under the direction of the Site Contract Management department. Verify informed consent processes are adequately performed and documented for each subject/patient and assess safety and data integrity factors. Conduct all forms of site visits (pre‑study, qualification, initiation, routine monitoring, close‑out) in accordance with protocol, local laws, ICH‑GCP, and Precision SOPs; prepare and submit accurate monitoring reports. Document activities via confirmation letters, follow‑up letters, trip reports, communication logs, and other required documents per SOPs and client requirements. Review the Investigator Site File (ISF) for accuracy, timeliness, and completeness; reconcile ISF contents with the Trial Master File (TMF). Ensure investigator/physician sites archive essential documents per local regulations. Communicate protocol/study issues proactively to site personnel and Precision project and clinical trial management. Develop and maintain good working relationships with investigators and study staff, serving as an ambassador of Precision. Perform investigational product (IP) inventory, reconciliation, storage and security reviews; verify IP dispensation and administration per protocol. Identify and process Serious Adverse Events (SAEs) according to study procedures and demonstrate full understanding of SAE reporting. Identify site risks and, with minimal support, propose contingencies and resolve risks promptly. Prepare for and attend investigator meetings, sponsor face‑to‑face meetings, global monitoring/project staff meetings, and clinical training sessions as required. Travel as necessary according to project needs. Perform other duties as assigned by management. Qualifications Minimum Required: 4‑year college degree or equivalent experience in a scientific or healthcare discipline. Two or more years as a CRA in a CRO or pharmaceutical/biotech industry or equivalent, with relevant experience and demonstrated competencies in site management. Other Required: Excellent communication and organizational skills; team player. Experience monitoring oncology trials. Evidence of a client‑focused approach. Experience using computerized information systems, electronic spreadsheets, word processing, and e‑mail. Ability to travel overnight; up to 60% travel on average; international travel as needed. Fluency in English; for non‑English speaking countries, fluency in the local language of the country where the position is based. Preferred: Graduate or postgraduate degree. Auto‑immune monitoring experience. Experience monitoring rare and complex therapeutic areas. Experience monitoring EDC trials and EHR records. Experience in biopharma or a relevant therapeutic area. Relevant site start‑up experience (feasibility, contract negotiations, submissions) for the applicable country. Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP, and ICH guidelines. Ability to resolve project‑related problems and prioritize workload to meet deadlines with minimal support from management. Competencies Exhibits self‑motivation and works independently as well as in a team environment. Understands clinical trials methodology and protocols. Demonstrates professionalism, punctuality, commitment, service culture, and positive interactions with customers and teammates. Collects data consistently at a high standard. Demonstrates ability to conduct formal presentations to diverse audiences. Fluency in English; for non‑English speaking countries, fluency in the local language of the country where the position is based. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristics protected by law. #J-18808-Ljbffr Precision Medicine Group