Sr CRAI/Sr CRAII (Gauteng) Sponsor dedicated

Senior Clinical Research Associate (CRA) - Real World Late Phase (RWLP) - Remote (ZAF-Remote)

Syneos Health is a leading biopharmaceutical solutions organization dedicated to accelerating medical research and patient care.

• Perform site qualification, site initiation, interim monitoring, site management, and close out visits (on site or remote) ensuring regulatory, ICH GCP, and Good Pharmacoepidemiology Practice (GPP) compliance.
• Evaluate overall site performance, provide recommendations for site specific actions, and communicate/escalate serious issues to the project team, developing action plans.
• Verify that informed consent processes are adequately performed and documented for each subject/patient, safeguarding confidentiality and protecting safety and data integrity.
• Conduct source document review, verify that clinical data entered in the case report form (CRF) is accurate and complete, and resolve queries promptly.
• Support investigational product (IP) inventory management, including reconciliation, storage security, dispensing, and administration according to protocol.
• Review the Investigator Site File (ISF) for accuracy, timeliness, and completeness; reconcile with the Trial Master File (TMF) and ensure proper archiving.
• Document activities via confirmation letters, follow up letters, trip reports, communication logs, and other required project documents.
• Support subject recruitment, retention, and awareness strategies; track observations, status, and action items in tracking systems.
• Understand project scope, budgets, and timelines; manage site level activities and communications to meet objectives, deliverables, and deadlines.
• Act as primary liaison with project site personnel or collaborate with Central Monitoring Associate, ensuring training and compliance.
• Prepare for and attend investigator meetings, sponsor face to face meetings, and global clinical monitoring/project staff meetings.
• Provide guidance on audit readiness and support audit preparation and follow up actions.
• Mentor junior CRAs and conduct training or sign off visits for junior staff, as assigned.
• Provide site support throughout the study lifecycle from site identification through close out.
• Apply local requirements for real world late phase study designs.
• Perform chart abstraction activities and data collection.
• Collaborate and build relationships with sponsors, affiliates, medical science liaisons, and local country staff.
• Identify and communicate out of scope activities to Lead CRA/Project Manager.
• Proactively suggest potential sites based on local treatment patterns, patient advocacy, and healthcare provider associations.
• Identify operational efficiencies and process improvements.
• Develop country level informed consent forms.
• Collaborate with the RWLP Regulatory team to incorporate updated regulatory information.
• Participate in bid defense meetings.

• 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.
• Demonstrated computer skills and ability to embrace new technologies.
• Excellent communication, presentation, and interpersonal skills; basic critical thinking skills expected.
• Ability to travel up to 75% of the time on a regular basis.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: One of our staff members will work with you to provide alternate means to submit your application.