[Hiring] FSP Senior CRA I/ II @Syneos Health

Role Description

The FSP Senior CRA I/II will perform the following responsibilities:

• Conduct site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remotely) ensuring compliance with regulatory, ICH-GCP, GPP, and protocol.
• Evaluate overall site performance and provide recommendations for site-specific actions; communicate serious issues to the project team and develop action plans.
• Maintain knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
• Verify informed consent processes and protect subject/patient confidentiality.
• Assess factors affecting subject/patient safety and clinical data integrity.
• Conduct Source Document Review and verify clinical data accuracy and completeness.
• Apply query resolution techniques and provide guidance to site staff.
• Utilize hardware and software for effective clinical study data review and capture.
• Perform investigational product inventory, reconciliation, and verify compliance with protocol.
• Review the Investigator Site File for accuracy and completeness.
• Document activities via confirmation letters, trip reports, and other required project documents.
• Support subject/patient recruitment and retention strategies.
• Understand project scope, budgets, and timelines; manage site-level activities to meet project objectives.
• Act as primary liaison with study site personnel and ensure compliance with requirements.
• Prepare for and attend Investigator Meetings and sponsor meetings.
• Provide guidance towards audit readiness standards and support audit preparation.
• 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.
• Collaborate with Sponsor and other affiliates.
• Train junior staff as needed.
• Identify and communicate out of scope activities.
• Propose potential sites based on local knowledge.
• Identify operational efficiencies and process improvements.
• Develop informed consent forms.
• Collaborate with RWLP Regulatory team.
• Participate in bid defense meetings and provide input into RFPs.
• Participate in Case Report Form design and edit check development.

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

• Passionate about developing 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.
• Collaboration with smart colleagues to drive impact for customers.

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.