Promethera Biosciences is a global innovator in liver therapeutics whose mission is to bring life-saving treatments to reduce the need for liver transplantation. Our lead clinical program, derived from our patented cell technology platform HepaStem, is designed to benefit from its immune-modulatory and anti-fibrotic properties. In addition to our cell-based pipeline, we develop antibody technologies, such as the anti-TNF-R1 antibody Atrosimab, to complement and diversify our therapeutic options. We are a team of international experts operating out of facilities in Mont-Saint-Guibert, Belgium, Durham, NC, USA, Tokyo, Japan and Basel, Switzerland.
If you are sharing our vision of becoming the world leader in regenerative medicine in the liver space by developing innovative advanced therapies for acquired liver diseases and if you are looking for new challenges amongst a dynamic and international team of more than 140 people, consider a collaboration with our fast-growing company. Promethera Biosciences is currently hiring a Clinical Research Associate (CRA).
- Develops protocols, informed consent forms, CRFs and CRF instructions, site selection materials, training materials, regulatory binders, study coordinator handbooks, other monitoring tools as required by the study, as well as study specific guidelines.
- Involved in recruitment of potential Investigators, preparation of Independent Ethics Committee/ Independent Regulatory Board (IEC/IRB) submissions, notifications to regulatory authorities, translation of study related documentation, organization of meetings and other tasks as instructed by the CSM;
- Suggests innovative approaches for and participates in the site selection process through conducting telephone screening interviews, administration of questionnaires, obtaining and reviewing budgetary information as well as CVs and other required regulatory documents, conducting pre-study site visits and providing overall assessment of potential site’s ability to conduct planned studies.
- Participates in CRA or protocol specific training and development activities such as literature search/review, in-service or offsite seminars and other professional development activities.
- Suggests innovative approaches for and participates in investigator meetings through preparation of training materials, coordination of investigator meeting and agenda, assembly and shipment of materials and attendance and presentation as required.
- Negotiates investigator budgets and assists with the execution of site contracts with support from the legal department;
- Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports;
- Conducts site initiation visits with study site staff for the purpose of training about or reviewing of: drug accountability, SAE reporting, protocol, study procedures, document retention requirements, patient recruitment and retention requirements, GCP and regulatory requirements. Outstanding regulatory documents are also collected during such visits.
- Develops patient enrollment strategies with the project team and clinical trial sites by:
- Providing protocol-specific information updates and in-services as needed during its course;
- Assisting in the development of patient education materials;
- Facilitating the exchange of creative ideas between study coordinators;
- Assisting in public awareness/advertising specific to the clinical trial and the facility.
- Conduct monitoring visits: ensures adherence to protocol, trial oversight, accurate data collection via comprehensive source document verification, and investigational product/biological samples/supplies accountability; ensures the integrity of clinical data with respect to accuracy, accountability, documentation and methods or procedure through review of case report forms (CFRs), source documents and medical records.
- Communicates effectively with site personnel, including the Principal Investigator (PI), and Promethera Biosciences to relay protocol/study deviations and ensure timely implementation of corrective and preventive actions;
- Ensures proper storage, dispensation and accountability of clinical trial materials.
- Documents monitoring results, listing deficiencies and corrective action needed.
- Trough demonstrated proficiency and basic understanding of the regulations governing the conduct of clinical drug evaluations, maintains responsibility for management of the clinical trial site and adherence to sponsor specific operating procedures and agreements by :
- Providing guidance to study coordinators and investigators;
- Anticipating/identifying potential an actual problem that occur;
- Notifying the CSM and appropriate personnel of site and/or study problems, concerns, progress;
- Implementing corrective and preventive actions when appropriate;
- Recognizing proper channels for communication.
- Identifies and processes Serious Adverse Events (SAEs) according to the procedures defined by the study team;
- Conducts study site close out visits for the purpose of inventory and return of all study drug, collects remaining CRFs and a final study report, resolves remaining data clarification and final subject status and ensures compliance with regulatory requirements.
- Provides study site evaluation. Ensures site registration in investigator Database.
- Attends team meeting, investigator meetings and client meetings as required.
- Reviews study materials and communications provided by CSM and other study staff in a timely manner and provides appropriate feedback when necessary.
- Demonstrates proficiency in the use of computer systems: E-mail, word processing, study site management and remote data entry software.
- Represents Promethera Biosciences to investigators, administrators, and personnel from pharmaceutical companies, hospitals, clinics and other research institutions.
- Assists with the development of departmental project-specific standard operating procedures.
- Prepares accurate and timely visit reports from all types of visits.
- Interacts with internal work groups to evaluate needs, resources and timelines;
- Initiates payment requests for Investigators;
- Performs other duties as assigned by management;
- Travels as necessary according to project needs.
- Multilingual - Fluency in English required
- Bachelor’s Degree in Life sciences.
- Good understanding of clinical trials and current knowledge of ICH-GCP.
- Excellent attention to detail and established organizational skills.
- Demonstration of flexibility, professionalism and good interpersonal skills.
- Excellent computer skills.
- Excellent verbal and written communication, interpersonal, and organizational skills.
- Full driving license and willingness to travel on regular intervals nationally and internationally.
- At our headquarters in Mont-Saint-Guibert / Gosselies, Belgium
You may apply for this position by sending your CV and application letter to email@example.com
Please note that, due to the high number of applications we receive, only retained candidates for interview will be contacted.