Experienced SrCRA with oncology experience

Syneos Health is seeking an Experienced SrCRA with oncology experience.

As a Senior Clinical Research Associate (SrCRA), you will play a critical role in ensuring the successful execution of clinical trials. You will be responsible for performing site qualification, site initiation, interim monitoring, site management, and close-out visits.

Key Responsibilities:

• Perform site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
• Evaluate overall performance of site and site staff, providing recommendations regarding site-specific actions.
• Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
• Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site.
• Conduct Source Document Review of appropriate site source documents and medical records.
• Verify required clinical data entered in the case report form (CRF) is accurate and complete.
• Apply query resolution techniques remotely and on-site, and provide guidance to site staff as necessary.
• Utilize available hardware and software to support the effective conduct of the clinical study data review and capture.
• 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 to track all observations, ongoing status, and assigned action items to resolution.
• 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, 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 and support preparation for audit and required follow-up actions.
• 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.
• Good computer skills and ability to adapt to new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Ability to manage required travel of up to 75% on a regular basis.

What We Offer:

• Competitive salary.
• Opportunity to work with a leading fully-integrated life sciences services organization.
• Collaborative and dynamic work environment.
• Professional development and growth opportunities.