Sr CRA - Sponsor Dedicated - Endocrinology & Cardiology; Home-Based in Western

Sr CRA - Sponsor Dedicated - Endocrinology & Cardiology (Home-Based in Western US)

Updated: December 9, 2025
Location: Morrisville, NC, United States

Description

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Work here matters everywhere. Why Syneos Health:
We are passionate about developing our people through career development, supportive line management, technical and therapeutic area training, and peer recognition.

• Performs site qualification, site initiation, interim monitoring, site management and close‑out visits ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site‑specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.
• Verifies and documents informed consent, protects confidentiality, assesses factors that might affect subject safety and clinical data integrity at investigator/physician sites.
• Per the Clinical Monitoring/Site Management Plan (CMP/SMP): assesses site processes, conducts source document review, verifies required clinical data, applies query resolution techniques and drives query resolution to closure.
• May perform investigational product inventory, reconciliation and reviews storage and security; verifies IP dispensation and administration per protocol.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness and reconciles contents with the Trial Master File (TMF).
• Documents activities via confirmation letters, follow‑up letters, trip reports, communication logs and other required project documents per SOPs and the Clinical Monitoring Plan/Site Management Plan.
• Understands project scope, budgets and timelines; manages site‑level activities and communication to ensure project objectives, deliverables and timelines are met.
• May act as primary liaison with project site personnel or collaborate with Central Monitoring Associate, ensuring training and compliance with applicable requirements.
• Prepares for and attends investigator meetings and/or sponsor face‑to‑face meetings; may lead global clinical monitoring/project staff meetings.
• Provides guidance toward audit readiness standards and supports preparation for audit.
• May provide training or mentorship to more junior level CRAs and perform training and sign‑off visits for junior CRA staff.
• Additional responsibilities include real‑world late‑phase support: site support throughout the study lifecycle, chart abstraction, collaboration with sponsor affiliates, identify out‑of‑scope activities, suggest potential sites, identify operational efficiencies, develop country‑level informed consent forms, collaborate with regulatory team and participate in bid defense meetings.

• 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.
• Must demonstrate good computer skills and be able to embrace new technologies.
• Excellent communication, presentation and interpersonal skills; basic critical thinking expected.
• Ability to manage required travel of up to 75% on a regular basis.

• Company car or car allowance, health benefits (medical, dental, vision), company match 401(k), employee stock purchase plan, commissions/bonus based on performance, flexible paid time off (PTO) and sick time.

Syneos Health is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, and to equal employment opportunities in accordance with all applicable laws. We strive for a diverse, equitable and inclusive workforce.