[Hiring] Senior Clinical Research Associate @Alimentiv

Role Description

As a Senior Clinical Research Associate, you will play a key role in the successful delivery of clinical trials by independently managing clinical site monitoring and site management activities across South Africa, from study start-up through close-out. You will act as a primary point of contact for investigative sites in these countries, ensuring compliance with protocols, ICH-GCP, applicable regulations and study requirements while supporting high-quality patient data and study delivery.

This is a senior individual contributor role with responsibility for supporting site performance, resolving issues, maintaining study documentation and providing guidance and mentorship to junior CRAs. You will work closely with Clinical Operations, Project Management, sponsors and other cross-functional teams in a dynamic clinical research environment.

Key Responsibilities

• Independently conduct and document onsite and remote monitoring activities, including site qualification, initiation, monitoring and close-out visits.
• Ensure investigative sites comply with study protocols, ICH-GCP, applicable regulations, SOPs and project-specific requirements.
• Serve as a primary point of contact for assigned sites, managing site-related questions, issues, action items and protocol deviations through to resolution.
• Review clinical trial data, source documentation and study systems to ensure accuracy, completeness, data integrity and compliance.
• Support site selection, activation and recruitment activities, working with sites to achieve study milestones and patient recruitment targets.
• Ensure sites are appropriately trained on protocols, study systems, processes and applicable requirements throughout the study lifecycle.
• Maintain oversight of essential study documentation, including ISF and TMF, ensuring documents are complete, accurate and filed in a timely manner.
• Collaborate with sponsors, project teams, vendors and investigative sites to support study timelines, resolve issues and maintain effective working relationships.
• Participate in audits and inspections, Investigator Meetings, study meetings and other project activities as required.
• Provide mentoring and support to CRA I and II colleagues, participate in co-monitoring and CRA assessment activities, and contribute to process improvement initiatives.

Qualifications

• Bachelor’s degree (Honours) in Life Sciences, Health Sciences, Pharmacy, Nursing or a related discipline; a Master’s degree is preferred.
• 4–6 years of relevant clinical research experience, with 7–9 years preferred.
• Strong clinical site monitoring experience across clinical trial activities from site start-up through close-out.
• Thorough knowledge of ICH-GCP, clinical research principles and applicable local regulatory requirements.
• Experience with Phase I–IV clinical trials preferred.
• Proficiency with clinical trial systems such as EDC, IRT, eTMF, CTMS and Microsoft Office, with experience in systems such as Medidata Rave or Oracle InForm preferred.
• Strong understanding of site management, including site activation, recruitment, training, issue resolution and maintenance of essential documentation.
• Excellent communication, interpersonal and relationship-management skills, with the ability to work effectively with investigative sites, sponsors and cross-functional teams.
• Strong organisational, problem-solving and prioritisation skills, with a high level of attention to detail and a sense of urgency.
• Ability to work independently, demonstrate sound judgement and manage competing priorities in a results-driven environment.
• Experience mentoring or supporting junior CRAs is preferred.
• Willingness and ability to travel approximately 40–60%, depending on project requirements and geographic location.
• Valid driver’s licence required.
• Fluent written and verbal English.

Benefits

• Education Reimbursement program for full-time employees.
• Monthly Cell Phone and Remote Work Allowance (dependent on role eligibility).
• One time office setup allowance (can be used to purchase a scanner/printer, extra monitor, office furniture, etc.).
• Working while visiting program – up to 4 weeks per year!
• Flexible Summer Hours Program from May – September.
• Employee referral incentive – we know great people know other great people, and we think that warrants recognition!
• Full-time employees also become beneficiaries of the Alimentiv Trust after one year of employment, and permanent members after 5 years of employment.
• Optional formal mentorship program (Alimentorship); country/region annual social events in person; leadership development programs for people leaders in accordance with your seniority; social committee and several other optional initiatives designed to support you in feeling like part of the Alimentiv team!
• Additional benefits may be available depending on the country of employment and are subject to local policies and eligibility.