CRA II

Updated: February 5, 2026
Location: ZAF-Remote
Job ID:

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 that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we're able to create a place where everyone feels like they belong.

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remotely), ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Evaluates site and staff performance; communicates/escalates serious issues to the project team and develops action plans. Maintains working knowledge of ICH/GCP guidelines, relevant regulations, and SOPs/processes.
• Verifies informed consent is obtained and documented for each subject, protects confidentiality, and assesses factors affecting subject safety and data integrity at investigator/physician sites (e.g., protocol deviations and pharmacovigilance issues).
• Per the CMP/SMP: assesses site processes, conducts Source Document Review, verifies CRF data accuracy/completeness, resolves queries remotely/on-site, and supports data capture and EDC compliance.
• May perform IP inventory, reconciliation, storage/security review; ensures IP dispensing/administration per protocol; handles IP labeling/importing/release/return per GCP/local regulations.
• Routinely reviews ISF for accuracy and timeliness; reconciles with TMF; ensures archiving of essential documents per local guidelines.
• Documents activities via letters and logs; supports recruitment/retention strategies; enters data into tracking systems to monitor observations, status, and action items.
• Understands project scope, budgets, and timelines; manages site-level activities/communication to meet objectives; adapts to changing priorities.
• May act as primary liaison with study site personnel or with Central Monitoring Associate; ensures training and compliance of sites and site team members.
• Prepares for and attends Investigator Meetings and sponsor meetings; participates in global clinical monitoring/project staff meetings and training sessions as required.
• Provides guidance toward audit readiness and supports audit preparation and follow-up actions.
• Maintains knowledge of ICH/GCP guidelines and company SOPs; completes required training. For Real World Late Phase, CRA II may use Site Management Associate II title. Additional responsibilities include site support through the study lifecycle, chart abstraction activities, collaboration with sponsor affiliates/medical science liaisons/local country staff, training junior staff, and identifying out-of-scope activities.

• Bachelor's degree or RN in a related field or equivalent
• Knowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirements
• Strong computer skills and ability to adopt new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to travel up to 75% regularly
• US ONLY: As part of employment, you may be deployed to sites requiring certain personal information for facility access. You may be asked for additional information beyond what is in our possession. Compliance with site requests is a condition of employment; failure to provide information may result in site entry restrictions.

Over the past 5 years, we have worked with 94% of Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients.

We aim to create a diverse, inclusive, and authentic workplace. A career with Syneos Health means your everyday work improves patients' lives around the world.

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or any other legally protected status. If you require reasonable accommodation to complete the application process, contact .

Summary

Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location, including remote monitoring to verify compliance with regulatory requirements and clinical protocols. Uses data analytics and risk-based monitoring to identify issues and trends; collaborates with site teams to develop tools and processes to enhance quality monitoring and trial success. This is typically an individual contributor role, potentially with some leadership of processes or small teams.