Description
Syneos Health is seeking an experienced Senior CRA to join their team in Switzerland. The successful candidate will be responsible for performing site qualification, site initiation, interim monitoring, site management, 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, 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
- 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 for own and others' activities in the clinical team
- Manage site-level activities/communication to ensure project objectives, deliverables, and timelines are met
- Act as primary liaison with project site personnel
- 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
- May provide training or mentorship to more junior level CRAs
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
- Previous monitoring experience
- Oncology knowledge
- Must demonstrate good computer skills and be able to embrace new technologies
- Excellent communication, presentation, and interpersonal skills
- Fluency in German; French would be an asset
- Ability to manage required travel of up to 75% on a regular basis