Are you an experienced CRA with thorough knowledge of regulatory processes ? You are fluently trilingual and up for a new challenge in a dynamic environment ? You like to be pro-active, take initiative and move forward ? This opportunity may be what you are looking for !
Job Description
The Clinical Site Lead/Site Regulatory Submissions associate operates under minimal supervision for their assigned sites. This person preferably has a monitoring background in a Medical Device company and can cover all tasks associated to their assigned sites, from start up (qualification, submission to EC / CA and site training) to monitoring and data quality, to enrollment driving activities.
Responsibilities
Prepare documents for Ethics Committee/Competent Authority (EC/CA) submission in the assigned region.
Initiate translation of documents as applicable (e.g. Patient Informed Consent); review and adapt translations to appropriate verbiage.
Prepare Country/Site Specific Patient Informed Consent form according to Regulatory and EC requirements and obtain internal approval where applicable.
Interpret clinical study protocols in order to support EC/CA submission where layman terms are required
Point of contact of EC /CA
Perform the submissions to EC/CA
Support approval process (adaption of documents according to EC/CA requirements; responses ….)
Support budget adoption to country and site requirements.
Prepare submission to any other authority when applicable
Maintain local regulatory documents on paper or electronically as applicable and ensure upload to data management system (DMS) were applicable.
Provide support to CSL / Clinical Project Teams
Assists in the development and review of informed consent document/patient information sheet to ensure all required elements are included.
Assist with collection of site activation documents.
Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution.
Facilitate all aspects of the start-up process and site initiation visits
Understand regulatory and legal requirements for study participation at a level that allows for appropriate collaboration with clinical staff, e.g. Site CRA, Site Contract Associate.
Train facility staff regarding protocol requirements and technology.
Develop site-specific strategies to promote appropriate patient enrollment.
Identify site successes and challenges and assist in implementing techniques that promote study goal achievement.
Continuously evaluate site study performance and provide timely feedback to site.
Develop site-specific strategies to avoid deviations.
Educate site on tools to facilitate compliance.
Provide timely feedback to the sites on key compliance indicators.
Escalate non-compliant sites according to corporate policy.
Collect essential documents, identify and obtain missing data, data corrections, reviewing adverse events and protocol deviations.
Conduct Site Initiation Visits, Periodic Monitoring Visits and Close Out Visits per study specific Monitoring Plan
Review data and source documentation from investigational sites for accuracy and completeness
Facilitate resolution of data queries and action items at clinical sites
Promptly reports the findings of monitoring visits according to the company's processes.
Maintain accurate, detailed and complete records of monitoring visits.
Profile
Experience with clinical regulatory
Bachelor's Degree in engineering, science, health science, nursing, or a related field, OR equivalent or related experience in cardiology or clinical research.
Proficient in operating a personal computer and in using various PC-based software packages including Microsoft Word, Excel, or similar word processing/spreadsheet software.
Experience with Databases is desired.
Fluent in Dutch, French and English. The ability to read, write, and communicate effectively in French and Dutch is required; this requirement includes clear, understandable speech, demonstrated comprehension skills, and demonstrated competence in French and Dutch spelling, grammar and punctuation and the ability to effectively correspond with laymen as well as EC/CA representatives.
A general familiarity with cardiac, vascular, and/or neuromodulation technologies, and clinical research processes is desired, along with related experience in a medical device/pharmaceutical company or relevant clinical experience in a clinical/hospital environment.
Benefits
A balanced salary package based on your capabilities and experience.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number : 17478
