Description
Syneos Health is seeking a Clinical Research Associate II to join their Clinical Solutions team. The successful candidate will perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits. They will also verify the process of obtaining informed consent, assess factors that might affect subject/patient's safety and clinical data integrity, and apply query resolution techniques.
Responsibilities:
- Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits
- Verify the process of obtaining informed consent has been adequately performed and documented
- Assess factors that might affect subject/patient's safety and clinical data integrity
- Apply query resolution techniques remotely and on-site
- Utilize available hardware and software to support the effective conduct of the clinical study data review and capture
- Verify site compliance with electronic data capture requirements
- May perform investigational product (IP) inventory, reconciliation, and reviews storage and security
- Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness
- Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
- Support subject/patient recruitment, retention, and awareness strategies
- Enter data into tracking systems as required
- Understand project scope, budgets, and timelines; manage site-level activities/communication to ensure project objectives, deliverables, and timelines are met
- May act as primary liaison with study site personnel or in collaboration with Central Monitoring Associate
- Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings
- Provide guidance at the site and project level towards audit readiness standards
- Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
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
- Good 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