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.
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 email@example.com