Syneos Health
10,000+ employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
Senior CRA, IoR & Regulatory Experience
🔥 0 minutes ago
📊 Check your resume score for this job
Improve your chances of getting an interview by checking your resume score before you apply.
Syneos Health
10,000+ employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
📋 Description
• Perform site qualification, site initiation, interim monitoring, site management, and close-out visits on-site or remotely • Ensure regulatory, ICH-GCP/GPP, protocol, and site compliance • Evaluate site and staff performance; communicate serious issues and develop action plans • Verify informed consent processes, subject/patient confidentiality, safety, protocol deviations, violations, and pharmacovigilance issues • Assess site processes and conduct source document and medical-record reviews • Verify clinical data entered in CRFs and resolve queries within agreed timelines • Support electronic data capture and verify site compliance • Manage investigational product inventory, reconciliation, storage, dispensing, administration, labeling, import, and return/release as applicable • Review and reconcile Investigator Site Files with Trial Master Files and ensure appropriate archiving • Document monitoring activities, track observations and action items, and support recruitment and retention • Manage site-level activities and communications to meet project objectives, deliverables, budgets, and timelines • Liaise with study-site personnel and ensure assigned sites and project staff are trained and compliant • Prepare for and attend investigator, sponsor, monitoring, project, and clinical training meetings • Support audit readiness, audit preparation, and follow-up actions • Provide supervision, training, mentorship, and sign-off visits for junior CRAs • For RWLP, support sites throughout the study lifecycle, chart abstraction, data collection, sponsor and affiliate relationships, site identification, informed-consent form development, regulatory coordination, process improvements, RFPs, bid defenses, budgeting, site-management strategy, CRF design, and edit-check development
🎯 Requirements
• 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 • Strong informed consent, source document review, clinical data review, and regulatory compliance knowledge • Good computer skills and ability to embrace new technologies • Excellent communication, presentation, and interpersonal skills • Moderate critical thinking skills • Ability to manage required travel of up to 75% on a regular basis
🏖️ Benefits
• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Total Self culture supporting authenticity and belonging • Diversity, inclusion, and a sense of belonging • Reasonable accommodations, when appropriate
Apply Now
