Role Description

The Contractor CRA will perform various responsibilities including:

• Site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remotely).
• Ensuring compliance with regulatory, ICH-GCP, GPP, and protocol standards.
• Evaluating site performance and providing recommendations for site-specific actions.
• Maintaining knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs.
• Verifying informed consent processes for each subject/patient.
• Protecting subject/patient confidentiality and assessing safety factors affecting clinical data integrity.
• Conducting Source Document Reviews and verifying clinical data accuracy.
• Applying query resolution techniques and providing guidance to site staff.
• Verifying compliance with electronic data capture requirements.
• Performing investigational product inventory and ensuring proper dispensing and administration.
• Reviewing the Investigator Site File for accuracy and completeness.
• Documenting activities via confirmation letters, trip reports, and other required documents.
• Supporting subject/patient recruitment and retention strategies.
• Managing site-level activities to meet project objectives and timelines.
• Acting as a primary liaison with study site personnel.
• Preparing for and attending Investigator Meetings and sponsor meetings.
• Providing guidance towards audit readiness standards.
• May supervise, train, and mentor junior CRAs.
• For Real World Late Phase (RWLP), additional responsibilities include:
• Site support throughout the study lifecycle.
• Chart abstraction activities and data collection.
• Collaborating with Sponsor and local staff.
• Training junior staff as needed.
• Identifying operational efficiencies and process improvements.
• Participating in bid defense meetings and providing input into RFPs.

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.
• Moderate level of critical thinking skills expected.
• 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.

Company 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.

Over the past 5 years, we have worked with:

• 94% of all Novel FDA Approved Drugs.
• 95% of EMA Authorized Products.
• Over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop, and advance.