[Hiring] Senior Clinical Research Associate @Syneos Health

Role Description

The Sr Clinical Research Associate will perform various responsibilities including:

• Site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remotely).
• Ensuring regulatory, ICH-GCP, and/or Good Pharmacoepidemiology Practice (GPP) compliance.
• Evaluating site performance and providing recommendations for site-specific actions.
• Maintaining knowledge of ICH/GCP Guidelines and relevant regulations.
• Verifying informed consent processes and protecting subject confidentiality.
• Assessing factors affecting subject safety and clinical data integrity.
• Conducting Source Document Reviews and verifying clinical data accuracy.
• Utilizing hardware and software for effective clinical study data review.
• Performing investigational product (IP) inventory and ensuring proper handling.
• Reviewing the Investigator Site File (ISF) for accuracy and completeness.
• Documenting activities via confirmation letters, trip reports, and communication logs.
• Supporting subject recruitment and retention strategies.
• Managing site-level activities and communications to meet project objectives.
• Acting as a liaison with project site personnel.
• Preparing for and attending Investigator Meetings and sponsor meetings.
• Providing guidance towards audit readiness standards.
• May provide training or mentorship to junior CRAs.
• Supporting site throughout the study lifecycle and collaborating with local teams.
• Identifying operational efficiencies and suggesting process improvements.

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.
• Basic level of critical thinking skills.
• Ability to manage required travel of up to 75% regularly.

Requirements

• Must demonstrate good computer skills.
• Ability to manage required travel of up to 75% on a regular basis.

Benefits

• Company car or car allowance.
• Health benefits including Medical, Dental, and Vision.
• Company match 401k.
• Eligibility to participate in Employee Stock Purchase Plan.
• Eligibility to earn commissions/bonus based on performance.
• Flexible paid time off (PTO) and sick time.