Promethera Biosciences is a global innovator in liver therapeutics whose mission is to enable patients to overcome acute and chronic liver diseases. 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 100 people, consider a collaboration with our fast-growing company. Promethera Biosciences is currently hiring a Clinical Research Associate.
- Administration and full investigator site responsibility for clinical studies according to Promethera Biosciences Standard Operating Procedures (SOPs), ICH-GCP and local regulations;
- Ensures clinical trials are monitored such that subjects' rights, safety and well-being are protected and that the clinical trial data are reliable;
- 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, 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, 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 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 actions when appropriate;
- Recognizing proper channels for communication;
- Identifies and processes Serious Adverse Events (SAEs) according to the procedures defined by the study team;
- Demonstrates a broad understanding of the SAE reporting process to regulatory authorities;
- 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;
- Participates in the interview and orientation process for new employees;
- Works with clinical data coordination group and medical staff to ensure that terminology on case report forms are correctly coded and that adverse events are properly documented and managed.
- Represents Promethera Biosciences to investigators, administrators, and personnel from pharmaceutical companies, hospitals, clinics and other research institutions;
- Assists with writing of narratives and interim/final study reports;
- Assists with the development of departmental project-specific standard operating procedures;
- Is alert for business potential for the company while on site visits and while in attendance at professional conferences/seminars;
- Prepares accurate and timely visit reports from all types of visits;
- May be involved in preparation of status reports for clients;
- 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.
QUALIFICATIONS / REQUIREMENTS
- 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, Belgium
You may apply for this position by sending your CV and application letter to email@example.com
Please note that, due to the the high number of applications we receive, only retained candidates for interview will be contacted.