[Hiring] Senior Clinical Research Associate II @Syneos Health

Role Description

The Sr Clinical Research Associate 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, and/or Good Pharmacoepidemiology Practices (GPP).
• Evaluate overall performance of site and site staff, providing recommendations regarding site-specific actions and communicating serious issues to the project team.
• Maintain knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
• Verify informed consent processes are adequately performed and documented for each subject/patient.
• Protect the confidentiality of each subject/patient and assess factors affecting safety and clinical data integrity.
• Assess site processes per the Clinical Monitoring/Site Management Plan (CMP/SMP).
• Conduct Source Document Review and verify clinical data accuracy in case report forms (CRF).
• 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 (IP) inventory and ensure compliance with protocol.
• Review the Investigator Site File (ISF) for accuracy and completeness.
• Document activities via confirmation letters, follow-up letters, trip reports, and communication logs.
• Support subject/patient recruitment, retention, and awareness strategies.
• Manage site-level activities and communication to meet project objectives and timelines.
• 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 preparations.
• May supervise, train, and mentor junior level 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.
• 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 Requests for Proposals (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.

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.

• Passionate about developing our people through career development and progression.
• Committed to building an inclusive culture where you can authentically be yourself.
• Continuously building the company we all want to work for and our customers want to work with.