Syneos Health
Life Sciences
SrCRAI
“Sr CRA I at Syneos Health. Skills: Clinical Research, Site Management, Regulatory Compliance. Perform site qualification, initiation, monitoring, management and close-out visits. Ensure regulatory, ICH-GCP and/or GPP and protocol compliance”
What You'll Achieve.
Accelerate customer success; Navigate complexity, anticipate change and accelerate progress; Achieve goals / targets; Drive query resolution to closure within agreed timelines; Ensure project objectives, deliverables and timelines are met; Shape solutions that have the ability to dramatically impact someone’s life; Drive impact for customers; Define the pace of patient progress
Industry & Context.
Basic level of critical thinking skills; Develops action plans
Ability to manage required travel of up to 75% on a regular basis, Sponsor dedicated
What They're Looking For.
Must Have
Bachelor's degree or RN in a related field or equivalent combination of education, training and experience, Minimum of 5+ years of experience in the pharmaceutical / biotechnology industry monitoring as a Clinical Research, Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements, Must demonstrate good computer skills and be able 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% on a regular basis
What You'll Do.
Perform site qualification
management and close-out visits
ICH-GCP and/or GPP and protocol compliance
Evaluate site performance and provide recommendations
Communicate and escalate serious issues to project team
Develop action plans for site issues
Maintain working knowledge of ICH/GCP Guidelines
Verify informed consent process adequacy and documentation
Protect subject/patient confidentiality
Assess factors affecting subject/patient safety and data integrity
Assess site processes per Clinical Monitoring/Site Management Plan
Conduct Source Document Review
Verify CRF data accuracy and completeness
Apply query resolution techniques
Provide guidance to site staff for query resolution
Utilize hardware and software for data review and capture
Verify site compliance with electronic data capture requirements
Perform investigational product inventory
Verify IP dispensed and administered per protocol
Verify IP related blinded or randomized information issues
Ensure IP appropriately (re)labelled
imported and released/returned
Review Investigator Site File for accuracy
timeliness and completeness
Reconcile ISF with Trial Master File
Ensure investigator site aware of essential document archiving requirements
Document activities via confirmation letters
Support subject/patient recruitment
retention and awareness strategies
Enter data into tracking systems
Manage site-level activities and communication
Adapt to changing priorities to achieve goals
Act as primary liaison with project site personnel
Ensure assigned sites and project-specific site team members are trained
Prepare for and attend Investigator Meetings
Participate in global clinical monitoring/project staff meetings
Attend clinical training sessions
Provide guidance towards audit readiness standards
Support preparation for audit and follow-up actions
Provide training or mentorship to junior CRAs
Perform training and sign off visits for junior CRA staff
Perform clinical operations lead tasks under supervision
Support study lifecycle from site identification through close out
Collect data for chart abstraction activities
Collaborate and build relationships with Sponsor and affiliates
Identify and communicate out of scope activities
Proactively suggest potential sites
Identify operational efficiencies and process improvements
Develop country level informed consent forms
Collaborate with RWLP Regulatory team
Participate in bid defense meetings
How You'll Work.
Team & Collaboration
Collaborate with passionate problem solvers, innovating as a team; Collaborate with project team; Collaborate with Central Monitoring Associate; Collaborate with RWLP Regulatory team; Collaborate and build relationships with Sponsor and other affiliates
Communication Scope
Excellent communication, presentation and interpersonal skills
Process & Methodology
Manages site-level activities / communication to ensure project objectives, deliverables and timelines are met, Understands project scope, budgets, and timelines
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