Clinical Research Associate II
hace 4 semanas
We are seeking a highly skilled Clinical Research Associate II - Site Management Associate II to join our team at Syneos Health. As a key member of our clinical development team, you will be responsible for ensuring the successful execution of clinical trials.
Key Responsibilities:
- Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
- Use judgment and experience to evaluate overall site performance and provide recommendations for site-specific actions.
- Maintain a working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
- Verify informed consent processes and protect subject/patient confidentiality.
- Assess factors affecting subject/patient safety and clinical data integrity.
- Conduct source document reviews, verify clinical data, and apply query resolution techniques.
- Verify site compliance with electronic data capture requirements and perform IP inventory, reconciliation, and reviews.
- Document activities via confirmation letters, follow-up letters, trip reports, and communication logs.
- Act as primary liaison with study site personnel and prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings.
- Participate in global clinical monitoring/project staff meetings and attend clinical training sessions.
- Provide guidance towards audit readiness standards and support preparation for audit and required follow-up actions.
Additional Responsibilities:
- Site support throughout the study lifecycle from site identification through close-out.
- Knowledge of local requirements for real-world late-phase study designs.
- Chart abstraction activities and data collection.
- Collaboration with Sponsor affiliates, medical science liaisons, and local country staff.
- The SMA II may be requested to train junior staff, identify and communicate out-of-scope activities, and proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy, and Health Care Provider associations.
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.
- Excellent communication, presentation, and interpersonal skills.
- Ability to manage required travel of up to 75% on a regular basis.
Why Syneos Health:
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
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