[Hiring] Senior Clinical Research Associate I @Syneos Health

Role Description

The Sr CRA I will perform site qualification, site initiation, interim monitoring, site management, and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Responsibilities include:

• Evaluating overall performance of site and site staff.
• Communicating/escalating serious issues to the project team and developing action plans.
• Maintaining knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifying informed consent processes and protecting confidentiality of subjects/patients.
• Assessing factors affecting subject/patient safety and clinical data integrity.
• Conducting Source Document Review and verifying clinical data accuracy in case report forms (CRF).
• Applying query resolution techniques and providing guidance to site staff.
• Performing investigational product (IP) inventory and ensuring compliance with protocols.
• Reviewing the Investigator Site File (ISF) for accuracy and completeness.
• Documenting activities via confirmation letters, follow-up letters, and trip reports.
• Managing site-level activities to ensure project objectives and timelines are met.
• Acting as primary liaison with project site personnel.
• Preparing for and attending Investigator Meetings and sponsor face-to-face meetings.
• Providing guidance towards audit readiness standards.
• May provide training or mentorship to junior level CRAs.
• Supporting site throughout the study lifecycle and collaborating with local teams.

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 expected.
• Ability to manage required travel of up to 75% on a regular basis.

Requirements

• Must demonstrate good computer skills and be able to embrace new technologies.
• Ability to manage required travel of up to 75% on a regular basis.

Benefits

• Passionate about developing our people through career development and progression.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Commitment to building an inclusive culture.
• Opportunity to shape solutions that impact lives.

Company Description

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress.

• Worked with 94% of all Novel FDA Approved Drugs over the past 5 years.
• Collaborated on 95% of EMA Authorized Products.
• Conducted over 200 Studies across 73,000 Sites and 675,000+ Trial patients.