Description
Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Job Responsibilities
- Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
- For the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes, Conducts Source Document Review of appropriate site source documents and medical records, Verifies required clinical data entered in the case report form (CRF) is accurate and complete.
- May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
- For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
- May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA).
- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
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
- Must demonstrate good computer skills and be able to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis