CRA - Sponsor Dedicated - Oncology + Neurology - of monitoring
Morrisville, Wake County, North Carolina, 27560, USA
Listed on 2026-01-09
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Science
Clinical Research, Medical Science
CRA I - Sponsor Dedicated - Oncology + Neurology - 6 months of monitoring experience required (Home-Based - Miami, FL / Orlando, FL)
Updated: January 5, 2026
Location: Morrisville, NC, United States
Job :-OTHLOC-1500-2
DGA-2DR
CRA I - Sponsor Dedicated - Oncology + Neurology - 6 months of monitoring experience required (Home-Based - Miami, FL / Orlando, FL)
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success by translating unique clinical, medical affairs and commercial insights into outcomes.
Job Responsibilities- Perform site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remotely), ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance.
- Verify informed consent processes, protect confidentiality and assess factors affecting subject safety and data integrity at investigators’ sites.
- For the Clinical Monitoring/Site Management Plan: assess site processes, conduct source document review, verify CRF data accuracy, resolve queries, support electronic data capture compliance.
- Perform investigational product inventory and compliance with IP procedures, including labeling, storage and security.
- Review Investigator Site File accuracy and reconcile with Trial Master File.
- Document activities via letters, trip reports and communication logs; support recruitment and retention strategies.
- Manage site-level activities, budgets, and timelines; coordinate with Lead CRA and adapt to changing priorities.
- Act as liaison with site personnel, ensuring training and compliance with requirements.
- Prepare for investigator and sponsor meetings, participate in global monitoring staff meetings, and attend clinical training sessions.
- Provide guidance toward audit readiness and support audit preparation and follow-up.
- For Real World Late Phase, serve as Site Management Associate I, support study lifecycle, chart abstraction and collaborate with sponsor affiliates and local staff.
- Bachelor’s degree or RN in a related field or equivalent experience.
- Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements.
- Strong computer skills and ability to embrace new technologies.
- Excellent communication, presentation and interpersonal skills.
- Ability to manage travel up to 30% of the time.
- US only: compliance with deployment and privacy notices regarding site access.
Benefits may include: company car or allowance, medical/dental/vision health benefits, 401(k) match, employee stock purchase plan, commissions/bonuses, flexible paid time off (PTO) and sick time. Eligibility for paid sick time may vary by state or municipality. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range: $62,000.00 – $
Actual salary will vary based on qualifications and experience.
Tasks, duties, and responsibilities listed herein are not exhaustive. The company may assign other tasks or duties at its sole discretion. Equivalency may be considered. This description complies with all applicable legislation and obligations, including the EU Equality Directive and the Americans with Disabilities Act.
SummaryRoles within Clinical Monitoring/CRA oversee and ensure the integrity of clinical research studies by monitoring data and processes from a centralized location. Responsibilities include remote monitoring of trial sites, verifying compliance with regulatory requirements and clinical protocols, utilizing analytics and risk-based monitoring techniques, and collaborating with site teams to support overall clinical trial success.
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