Clinical Research Associate

Late Phase Clinical Research Associate - development opportunity also possible

Location: Leiden, The Netherlands

Mapi is the leading Patient-Centered Research company serving academia, life science researchers, and the pharmaceutical industry. Our commitment to patients is reflected through our wide range of services, including Real World Evidence, HEOR, Linguistic Validation, Global Market Access, and our Mapi Research Trust.  Working within our Real World Evidence team, you will work with a team of professionals who provide strategic and operational expertise in the design and conduct of Post-Approval and commercialization programs for Pharmaceuticals, Biologics and Medical Devices. 

Combining the industry’s oldest and most experienced Clinical Outcome Assessments (COA) consultancies (Mapi & Oxford Outcomes), within ICON Commercialisation and Outcomes, and with access to more combined COA experience than all other CROs and consultancies,  Mapi can offer fantastic career opportunities. We provide a dynamic, stimulating and rewarding working environment for ambitious and passionate individuals looking to join a global, world-class consultancy business.

Your Responsibilities and Accountabilities:

As a Late Phase Clinical Research Associate at Mapi Group, you will be responsible for performing all monitoring and site management activities for observational studies within the Monitoring and Site Management (MSM) team. You will perform routine site visits to ensure that the rights and well-being of human subjects are protected; the trial data is accurate, complete, and verifiable from source documents. You will ensure that all activity is delivered in accordance with the study protocol, GCP/ICH/GEP guidelines and applicable regulatory requirements.

Whilst some travel required dependent upon your study, most of your work will be done on a 

remote basis with the primary focus being on the quality of data collected.  On average you can expect to do one to two visits per month at a location in either The Netherlands or Belgium.

Responsibilities:

• Perform site feasibility and site selection in conjunction with the Study team, or independently

• Work closely with relevant departments to perform Regulatory and IEC/IRB submissions and contract negotiations

• Perform onsite and remote visits including pre-study, site initiation, interim and close out to monitor informed consent procedures, compliance protocol, GCP/ICH guidelines and other applicable regulatory requirements and assure appropriate site performance

• Provide timely and accurate visit reports as specified by project specific timelines.

• Contribute to sponsor or regulatory site audits/inspections including preparation, attendance and follow-up of audit findings

• Maintain regular site contacts to ensure site compliance, enrollment and understanding of study requirements

• Maintain the Project Tracking System recording site visit dates, site contact notes, subject and site information

• Maintaining high quality standards, including identifying areas for improvement where applicable

• Assist with the development of departmental and project specific processes and procedures.

For this position, we would be also happy to consider a candidate who has not yet held the position of Clinical Research Associate but who would like to step into this position as the next stage of their career.  In this instance, we would be happy to receive applications from individuals who hold a relevant life science or medical degree and a position within a CRO/Pharma company with prior exposure to the CRA role and therefore a good understanding of the position.  You will need to be fluent in English and Dutch with French as an added benefit but not essential.

For more experienced candidates, you will have:

• A background as a CRA, ideally within late phase studies but not essential

• Strong knowledge of ICH/GCP guidelines and/or other relevant guidelines (GEP, GPP) and local requirements (including regulatory)

• Proficiency with computer/software systems

• Proven ability to manage multiple simultaneous tasks

• Fluency in both written and spoken English and Dutch

• Fluency in French as an added benefit but not essential.

• Bachelor degree or higher preferably in a scientific, medical or life sciences discipline

Next Steps:

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON Plc is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

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