CRA II - Oncology / Ophthalmology (Home-Based - Midwestern Region)

About the Role

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything we do. As a Clinical Research Associate II (CRA II) specializing in Oncology/Ophthalmology, you will perform site qualification, initiation, interim monitoring, site management, and close-out visits—either on-site or remotely—ensuring compliance with regulatory standards, ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and protocol requirements.

This is a home-based position serving the Midwestern region of the United States.

Responsibilities

• Perform site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remotely) to ensure compliance with regulatory, ICH-GCP, GPP, and protocol requirements.
• Evaluate site and staff performance, escalate serious issues to the project team, and develop action plans.
• Maintain working knowledge of ICH/GCP guidelines, relevant regulations, and company SOPs/processes.
• Verify the informed consent process is adequately performed and documented for each subject/patient.
• Assess factors affecting subject/patient safety and clinical data integrity, including protocol deviations and pharmacovigilance issues.
• Conduct Source Document Review (SDR) and verify accuracy and completeness of clinical data entered in case report forms (CRFs).
• Apply query resolution techniques and guide site staff to ensure timely closure of queries.
• Support effective clinical study data review and capture using available hardware and software.
• Verify site compliance with electronic data capture requirements.
• Perform investigational product (IP) inventory, reconciliation, and ensure proper storage, security, and dispensing per protocol.
• Review and reconcile the Investigator Site File (ISF) and Trial Master File (TMF) for accuracy, timeliness, and completeness.
• Document activities via confirmation letters, follow-up letters, trip reports, and communication logs per SOPs and the Clinical Monitoring Plan.
• Support subject/patient recruitment, retention, and awareness strategies.
• Enter data into tracking systems to monitor observations, status updates, and action item resolution.
• Manage site-level activities and communication to meet project objectives, deliverables, and timelines.
• Act as primary liaison with study site personnel or collaborate with Central Monitoring Associates.
• Ensure assigned sites and project-specific site team members are trained and compliant with requirements.
• Attend Investigator Meetings, sponsor meetings, and global clinical monitoring/project staff meetings.
• Support audit readiness and preparation, including follow-up actions.
• For Real World Late Phase studies, use the title Site Management Associate II (SMA II) and perform additional duties:
  • Provide site support throughout the study lifecycle, from identification to close-out.
  • Apply knowledge of local requirements for real-world late-phase study designs.
  • Conduct chart abstraction and data collection.
  • Collaborate with Sponsor affiliates, medical science liaisons, and local country staff.
  • Train junior staff as requested.
  • Identify and communicate out-of-scope activities to the Lead CRA/Project Manager.
  • Proactively suggest potential sites based on local treatment patterns, patient advocacy, and HCP associations.

Requirements

• Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
• Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other applicable regulatory requirements.
• Strong computer skills and ability to adapt to new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Ability to manage required travel of up to 75% on a regular basis.

US Only: As part of employment, you may be deployed to sites requiring certain medical or personal information for facility access. Compliance with site requests for additional information is required as a condition of employment.

Benefits

• Company car or car allowance.
• Comprehensive health benefits (Medical, Dental, Vision).
• Company-matched 401k retirement plan.
• Eligibility to participate in the Employee Stock Purchase Plan (ESPP).
• Opportunity to earn commissions/bonuses based on company and individual performance.
• Flexible paid time off (PTO) and sick time (compliance with state/municipal regulations).

Pay

The base salary range for this position is competitive and varies based on candidate qualifications, skills, competencies, and proficiency. Specific salary will be determined by these factors.