As a CRA II, you will perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

Key responsibilities include:

• Evaluating site performance and providing recommendations for site-specific actions
• Verifying informed consent and protecting subject/patient confidentiality
• Assessing site processes and conducting source document reviews
• Applying query resolution techniques and providing guidance to site staff
• Managing investigational product inventory and verifying dispensing and administration
• Reviewing investigator site files and ensuring compliance with regulations
• Documenting activities and supporting subject/patient recruitment and retention
• Collaborating with study site personnel and central monitoring associates
• Preparing for and attending investigator meetings and sponsor face-to-face meetings

Requirements:

• Bachelor's degree or RN in a related field or equivalent experience
• Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
• Excellent communication, presentation, and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis

Syneos Health offers a dynamic and supportive work environment with opportunities for career development and growth.

Job Data by YubHub.

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
• 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
• May act as primary liaison with study 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

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

Job Data by YubHub.