CRAII/ SCRA

Clinical Research Associate II (CRA II) – Site Management Associate II Job Overview The Clinical Research Associate II is responsible for site qualification, initiation, monitoring, and management throughout the clinical trial lifecycle. The role requires ensuring compliance with regulatory, ICH‑GCP, and Good Pharmacoepidemiology Practice (GPP) standards, and providing guidance to site staff to support study objectives. Job Responsibilities Perform site qualification, initiation, interim monitoring, site management activities and close‑out visits (on‑site or remotely) ensuring protocol compliance. Verify informed consent processes, protect subject confidentiality, assess safety and data integrity risks, and manage protocol deviations & pharmacovigilance issues. Conduct source document review, verify clinical data in CRFs, resolve queries, and support electronic data capture compliance. Perform investigational product inventory, reconciliation, storage, security, and labeling per protocol and regulatory requirements. Review the Investigator Site File and reconcile with the Trial Master File, ensuring necessary archiving. Document all activities via letters, trip reports, logs, and other project documentation as per SOPs and the Monitoring Plan. Assist in recruitment, retention, and awareness strategies; enter data into tracking systems to record observations and action items. Manage site‑level activities, budgets, timelines, and communications to achieve project objectives, and adapt to changing priorities. Act as primary liaison with site personnel or collaborate with Central Monitoring Associates; ensure training and compliance. Prepare for and attend investigator/sponsor meetings, global monitoring meetings, and training sessions. Provide audit‑readiness guidance and support audit preparation and follow‑up actions. Maintain knowledge of ICH/GCP guidelines, regulations, and SOPs; complete required training. Support study lifecycle from site identification to close‑out, including chart abstraction, data collection, collaboration with sponsor affiliates, medical science liaisons, and local staff; train junior staff as needed; suggest potential sites based on local knowledge. Qualifications Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience. Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. Strong computer skills and ability to embrace new technologies. Excellent communication, presentation and interpersonal skills. Ability to manage required travel of up to 75% on a regular basis. US‑only: compliance with site privacy and access requirements as per Employee Privacy Notice. Why Work With Us Career development and progression, supportive line management, technical & therapeutic area training, peer recognition and total rewards. Committed to a culture where employees can authentically be themselves (Total Self). Inclusive workplace that brings diverse backgrounds and perspectives to create a sense of belonging. Equal Opportunity Statement Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender identity, sexual orientation, veteran or disability status. If you are an individual with a disability who requires reasonable accommodation, please contact us at #J-18808-Ljbffr