Junior Clinical Research Associate

Novo Nordisk; Johannesburg; In loco; ZAR 350.000 - 520.000; Tempo pieno

Descrizione del lavoro

Novo Nordisk is seeking a Junior Clinical Research Associate to monitor clinical trial sites in Johannesburg, South Africa, ensuring adherence to ICH-GCP, and safeguarding participant safety and data integrity.

You will work across on-site and remote monitoring, collaborating with the study team to keep trials on schedule and compliant, with opportunities for international study exposure and CRA training.

Competenze

• Bachelor's degree in Life Sciences or related field required.
• Basic GCP qualification preferred.
• Minimum 2 years’ experience in industry-sponsored clinical research or up to 1 year as a CRA.
• Solid knowledge of ICH-GCP and regulatory requirements.
• Experience with EDC, CTMS and eTMF systems advantageous.
• Demonstrated ability to manage multiple sites and priorities.

Mansioni

• Oversee assigned sites with a mix of on-site and remote monitoring.
• Ensure participant safety and data integrity per protocols and ICH-GCP.
• Monitor recruitment, retention, data collection, and site performance.
• Train site staff on protocols and systems, manage investigational product and essential documents.
• Keep trials inspection-ready and support audits/inspections.
• Share feedback to improve protocols and trial processes.

Conoscenze

Bachelor's degree

GCP qualification

2+ years clinical research experience

ICH-GCP knowledge

Regulatory requirements

Clinical trial methodology

EDC/CTMS/eTMF familiarity

Strong organizational skills

Effective communication

Problem solving

Willingness to travel

Formazione

Bachelor's degree in Life Sciences

GCP qualification (basic)

Descrizione del lavoro

Job Title: Junior Clinical Research Associate (JCRA)

Department: Clinical Operations, Research & Development, (CDC South Africa)

Location: Johannesburg, South Africa. Travel to clinical trial sites is required.

Your impact begins here

As Junior Clinical Research Associate, you will be the link between Novo and the clinical trial sites where our studies happen. You will monitor how trials run in real life, protect the safety and rights of the people taking part, and make sure the data collected can be trusted. Your work keeps studies on track, on time and in line with ICH-GCP, so promising science can move forward with the quality people deserve.

What You’ll Bring

• A bachelor’s degree in Life Sciences or a related field.
• A basic GCP qualification.
• At least 2 years’ experience in industry-sponsored clinical research or up to 1 year of experience as a CRA.
• Solid knowledge of ICH-GCP, regulatory requirements and clinical trial methodology.
• Confidence using clinical trial systems such as electronic data capture (EDC), CTMS and eTMF.
• Strong organisation and time management skills, with the attention to detail needed to manage several sites and priorities at once.
• Clear written and verbal communication, and the ability to build trusted relationships with site staff and colleagues at all levels.
• A proactive, problem-solving approach: you spot risks early, elevate when needed and are open to better ways of working, including new digital tools.
• Flexibility to travel as required.

Useful, But Not Essential

• Experience in one or two multinational phase 2–3 clinical trials, ideally from site initiation through to site closure.

What You’ll Do

You will oversee your assigned sites from day to day, combining on-site and remote monitoring with risk-based quality management (RBQM) – focusing your attention where the risks to quality and safety are greatest.

• Act as the main point of contact between Novo, your clinical sites and the study team, conducting on-site and remote visits in line with the Monitoring Plan, Protocol, ICH-GCP, SOPs and local regulations.
• Protect participant safety and data integrity by reviewing site data, resolving discrepancies, managing adverse events and making sure data cleaning timelines are met.
• Track recruitment, retention, data collection and site performance so studies meet their timelines, quality objectives and clinical operations KPIs.
• Train and support site staff on protocols, procedures and systems, and manage investigational product, study supplies, equipment and essential documents, including the Investigator Trial Master File.
• Keep trials inspection-ready at every stage, support audits and inspections, and resolve or elevate site issues early.
• Share site feedback and practical ideas that improve protocols, patient engagement and the way we work, and support fellow CRAs through knowledge sharing.

Who You’ll Work With

In Research & Development, colleagues explore scientific ideas and advance them towards clinical testing. As part of Clinical Operations, you will help turn that work into well‑run trials at sites in South Africa.

Your closest partners will be investigators, study nurses and coordinators at your sites. Inside Novo, you will work alongside Trial Managers, the Study Start‑up team, Clinical Trial Administrators, payment specialists and fellow CRAs, and connect with trial squads and Global Project Teams. You may also engage with ethics committees, local health authorities and vendors.

You will report to Neo Nkonyane, Clinical Operations Manager and take part in investigator meetings, CRA training sessions and trial meetings, locally and globally. These relationships help you get clarity quickly, solve issues together and keep studies moving.

What You Can Expect Here

This is a role where you can grow your monitoring expertise on the job. You will take responsibility for your own sites while learning from experienced CRAs, your manager and the wider trial team, and build new skills through CRA training and international study meetings.

Your voice matters here. You are encouraged to speak up early, share what you see at site level and suggest simple improvements – because better ways of working lead to better trials for the people taking part in them.

Start now

Your impact begins today.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.