At Clinitude we strive to attract passionate and agile talents who thrive on growth and change.  As we are growing we are looking for a Clinical Research Associate for our Belgian office, based in Leuven.   This position is a permanent position.  Are you in for a role where  you can use all your expertise, your ideas and where you can work closely together with our Belgian team and Asian team in Cebu, the Philippines, and do you think you can be the perfect match, then please do not hesitate to apply.  We are looking for a CRA with experience leading a team and is looking for this extra pinch of experience to grow into the Clinical Research Account Manager role

About us

Clinitude is a CRO with headquarters in Leuven, Belgium and offices in Cebu, the Philippines.  Our branch offices are located in Singapore and Chicago, IL.  We are managing clinical studies (pharmaceutical and devices) globally.  We have a strong focus for risk management and (de)centralized monitoring of clinical trials and we strive to ensure quality and integrity of data for our clients but ultimately to help the patients to receive the best possible treatment.

Your responsibilities will include:

• performing site selection, initiation, monitoring and close out visits
• supporting in the development of subject recruitment plan.  Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability
• site management
• evaluating and ensuring quality and integrity of study site practices to the proper conduct of the protocol and adherence to regulations and applicable guidelines
• Proactively manage on a project level clinical research projects, if required
• Providing updates on trial progress to the Project Manager and/or Clinical Operations Manager
• managing the progress of the assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, CRF completion, data query generation and resolution
• may support the study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (eTMF) and vendor Clinical Trial Agreements and budgets
• creating and maintaining appropriate documentation regarding site management, monitoring visit findings and action plans by submitting visit reports, generating follow-up letters and other required study documentation
• Ensuring effective project plans are in place and operational for each trial and work proactively with the Clinical Trial Team to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines, ISO 14155 and regulatory requirements
• implementing a quality management plan
• ensuring timely resolution for compliance issues
• Training, mentoring and coaching team members, i.e. junior CRAs, CRA Liaisons
• support/work together with the assigned study team stakeholders, i.e. CRA Liaison, data management, biostatistics
• support together with the assigned team the SOP writing process, if applicable
• Coordinate the communication lines within study team with the applicable team members
• Participates in selection of vendors where applicable and support/manage vendor management
• Participating in team meetings

Requirements:

• University degree in health care or bachelor degree with equivalent of 2-3 years experience in clinical research
• Minimum of 2 years experience in clinical research with increasing levels of responsibility
• Experience in pharmaceutical studies and device studies
• mentoring and coaching experience
• Excellent communication and presentation skills
• Ability to negotiate and build relationships at all levels
• Effective management skills and first experience in leading a team/project
• Good command in English, Dutch and French
• Experience in risk management and centralized management/monitoring of clinical trials

If you are interested, please send us your CV and motivation and get in touch with us at hr@clinitude.com