Clinical Research Associate – Belgium

We are looking for Clinical Research Associate(s) to join our team in Belgium.    Supporting the clinical research by selecting the right sites to participate in clinical study, performing initiation visits and monitoring visits to ensure good quality of data and managing the site study team are the key ingredients for this role.  Are you interested to contribute to science, we just ask you to send us your CV and start your CRA carreer.

Your Responsibilities:

• Perform site selection if applicable, initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practice.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution. May support start-up phase.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Build awareness of features and opportunities of the study site.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable can be involved in the review of monitoring documents (e.g. monitoring plan, review of monitoring visit reports….).
• To implement a quality management plan
• To ensure timely resolutions for compliance issues

What do we ask from you?

• basic knowledge of clinical research
• strong written and verbal communication skills
• strong organizational and problem-solving skills
• effective time management
• ability to establish and maintain effective working relationships with colleagues, managers and clients
• degree in health care or scientific discipline or equivalent
• 1 year on site monitoring is a plus, but not a requirement

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

Clinical Operations Lead – Belgium

For our Belgian office Clinitude is looking for a Clinical Operations Lead (CO Lead).  The CO Lead supports the Clinical Operations Manager in the end-to-end delivery of services related to (remote) site management for the assigned team.  The CO Lead provides leadership and vision to the team and ensures customer satisfaction.  Are you the person that enjoys teaching other CRAs and coach them in becoming excellent in what they do?

Responsibilities

• To provide (remote) monitoring expertise to internal team members to manage continuous process improvements, issue escalation, workload projections and provide technical expertise If appropriate
• To provide and justify timelines, resources, processes to Clinitude Management team
• To ensure open communications, if applicable with project management team of client, and with Clinitude management team to manage and meet contractual obligations set with the client
• To meet with Clinitude team members on a regular basis to ensure milestones meet timelines and to ensure quality of monitoring is delivered
• To ensure strong communications with functional leads, project managers and other stake holders
• To work with functional manager(s) to make sure resources are assigned
• To implement a quality management plan, if applicable
• Provides training, mentoring and coaching team members, supports Manager Clinical Operations in re-evaluation and set up of training plan for all assigned team members. Provide mentorship, guidance and support to enable team members development.
• Provides input on the performance evaluation for assigned team member
• To ensure timely resolutions for compliance issues
• To train and mentor junior CRAs assigned on the project
• May support or lead internal workstreams
• Is involved in the Interview and selection of new staff members in either Belgian or Asian office, or freelancers
• Is involved in the onboarding of new staff members in either Belgian or Asian office, or freelancers

Your skills:

• Previous experience and proven competence in managing deliverables for projects through the Clinical project life cycle
• Demonstrates expert (remote) monitoring skills
• Knowledge of operating procedures
• Excellent communication, interpersonal and teamwork skills
• Team building and organizational skills
• Project management skills
• Organizational and problem-solving skills
• Comprehensive understanding of drug development process and/or device development process
• Standard Microsoft Office knowledge
• Line management experience is preferred but not required

Do you have a degree in health, clinical or biological sciences and previous experience in site management and project management?

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

Regulatory and Start-Up Associate – Belgium

At Clinitude we are looking for a Regulatory and Start Up Associate for our Belgian Office, Leuven.  Do you want to be involved in submission of clinical trials in Europe and in Asia, then you are the person Clinitude is looking for.  You will be working with an international team and you will be involved in submission of clinical trials and device trials.  With the new regulations and new submission procedures, you would like to bring your support and skills into our procedures.  You like working with international team, you would love to be involved in setting up the regulatory department at Clinitude in Europe and Asia, then please do not hesitate to send us your motivation and CV.

As Regulatory and Start Up Associate you are responsible for conducting and facilitating specific start-up and regulatory activities that may include feasibility, essential documents collection, ICF customization, EC and CA submissions, preparation and negotiation of Clinical Site contracts, ….

Your responsibilities are:

• Acts as Key-contact at country level for either Ethical or Regulatory submission-related activities.
• Assists Project Manager, Clinical team to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
• Prepares, reviews and coordinates the local regulatory submissions (MoH, EC, additional special national local applications if applicable, import licenses etc) in alignment with the global submission strategy.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Review, prepare and negotiate site contracts and budgets with sites, if applicable.
• Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics, ICF and IP Release documents, in line with project timelines.
• Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning.
• Supports Clinical team with accurately updating and maintaining relevant electronic systems, tracking tools, project plans that track Study / site compliance and performance within project timelines.
• Assist the Clinical team in preparation, handling distribution, filing and archiving of Clinical trial documentation and reports according to the scope of work and applicable SOP. Assists with the periodic review and quality control of study files for accuracy and completeness.
• Disseminates study related information, including project tracking updates to Clients, clinical study teams and other Clinitude departments.
• Interacts with external Clients, Sites and Service providers.
• May contribute to the selection of service providers.
• May assist clinical project team with the identification of potential investigators.
• May accompany CRA (liaisons) (on) site visits to assist with clinical monitoring duties related to Study start up upon completion of required training and with required approval.
• may support or lead internal workstreams.

Your knowledge and skills:

• Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., ICH GCP guidelines, General awareness of the drug/device development process.
• Knowledge of all applicable regional/national country regulatory guidelines and EC regulations is a plus but not required.
• Knowledge of the applicable protocol requirements as provided in the company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer.
• Strong written and verbal communication skills including good command of English language.
• Strong organizational and problem-solving skills.
• Effective time management skills and ability to work on multiple projects.
• Attention to details and accuracy in work.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Good interpersonal communication skills.

Your Education:

Bachelor’s degree, in health care or other scientific discipline or educational equivalent or equivalent combination of education, training and experience.

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

Lead Clinical Research Associate – Belgium

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

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Clinical Trial Assistant – Cebu

As a Clinical Trial Assistant (CTA) you are the right hand of the clinical study team.  Thanks to your administrative support within the designated study team, you will bring your team to the next level of excellence.  Clinitude is looking for your administrative talent in our Cebu office.

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