Job details
Job type full-time
Full job description
Avania is a leading, global full-service contract research organization focused on the management of clinical studies for medical devices, ivds, biologics, and device-drug combination products internationallyAvania supports products from the first-in-human phase through the post-market phase with the same customized approachWhen you need to advance your medical technology, it takes avaniaAvania’s vision is to be your trusted global partner in the evolution of your medical technology from innovation to commercialization to improving patient health and well-beingHttps://www.avaniaclinical.com/
Purpose
The main responsibility of this position is the establishment, maintenance and support of clinical trials, including but not limited to setting up clinical trials, training study sites on clinical trial procedures, performing monitoring visits, general study coordination and study/site closureThe main responsibility of the clinical research associate (cra) is to perform clinical trial oversight in addition to any study management tasks assigned by the project managerThrough the monitoring process, the cra verifies that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documentsMost importantly, the cra makes sure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with iso14155 or ich-gcp, and with applicable regulatory requirementsCras require skills in planning and preparation; sourcing and collecting information; prioritizing tasks and actions; and displaying a proactive attitude to assist in project planning and study executionCras may be required to initiate certain study start-up tasks until a project manager is appointedOnce a project manager is appointed, the cra will work under their guidance to achieve study aimsWithin the cra function different levels can be distinguished (level i, ii and srCra)Depending on the level of experience, cras can be responsible for tasks that are more complexAt management discretion, a cra may serve as a lead cra for a project if she/he has the appropriate qualifications and training to perform the role.
Duties and responsibilities:
Clinical trial monitoring:
May act as a clinical lead, overseeing clinical trial activities at investigational sites (will require travel to investigational sites).
Develop and maintain trackers, such as visit reports trackers, site trackers, recruitment and enrollment trackers.
Member of a site start-up team for various projects.
Conduct and write accurate visit reports in accordance with sops and gcp, including pre-study, site initiation, routine monitoring, and close-out visits.
Interact with and guide study investigators and study coordinators in conducting clinical trials in accordance with study protocols.
Ensure data entered on the crfs by investigational sites is performed in a timely manner and verify that data is consistent with patient clinical notes, known as source data/document verification (sdv).
Collaborate with analytical services as appropriate, to obtain clean database, resolve queries and conduct or participate in data reviews (both internally and with sponsor), identifying and communicating trends or erroneous data.
Monitor site’s completion of action items between visits.
Study-specific documents and files:
Prepare for audits and inspections.
Participate in internal tmf reviews, as needed.
Review and write informed consent forms.
Review of protocols, investigator brochures on compliance with applicable regulations and crfs in development.
Prepare clinical trial agreements and discuss/negotiate between site and sponsor.
Regulatory affairs:
Prepare submissions to institutional review board (irb) / ethics committees (ecs) and competent authorities (cas)/food and drug administration (fda), assist in administrative tasks for submissions and follow up until approval is obtained.
Prepare confidentiality agreements and complete templates of clinical trial/investigator agreements.
Prepare annual trial progress reports for irbs/ecs and cas/fda.
Report serious adverse events to sponsor, irbs/ecs, cas/fda and investigators.
Communication and meetings:
Participate in project meetings and investigator meetings and write minutes.
Function requirements
B.a./b.sOr equivalent experience in a (para)medical, scientific or health related discipline or related work experience.
Minimum 3-7 years of relevant work experience in clinical research, in particular as clinical research associate (cra) preferred.
Experience as a clinical lead.
Tracker and start-up experience.
Ability to understand basic and complex medical details
Gcp-ich-e6, fda regulations and iso 14155, 13485 and 9001 knowledge where applicable
Knowledge of regulatory regulations and guidelines on medical devices
Ability to travel domestically and internationally
Fluent english, spoken and written
We offer
Well outlined training program
The opportunity to work in (cross-functional) international teams
Career path opportunities for your grow within the company
A dynamic team
Various team activities
We look forward to receiving your motivation and cv.
