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/
Clinical trial monitoring:
Oversee clinical trial activities at investigational sites (will require travel to investigational sites).
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.
Regulatory affairs:
Prepare submissions to institutional review board (irb) / ethics committees (ecs) and competent authorities (cas)/food and drug administration (fda) and assist in administrative tasks for submissions.
Prepare confidentiality agreements and complete templates of clinical trial/investigator agreements.
Prepare annual trial progress reports for irbs/ecs and cas/fda under supervision.
(assist in) reporting serious adverse event to sponsor, irbs/ecs, cas/fda and investigators.
Communication and meetings:
Participate in project meetings and investigator meetings and write minutes.
Additional responsibilities:
Perform submissions to institutional review board (irb) / ethics committees (ecs) and competent authorities (cas)/food and drug administration (fda) and follow up until approval is obtained.
Prepare annual trial progress reports for irbs/ecs and cas/fda.
Report serious adverse events to sponsor, irbs/ecs, cas/fda and investigators.
Prepare clinical trial agreements and discuss/negotiate between site and sponsor.
B.a./b.sOr equivalent experience in a (para)medical, scientific or health related discipline or related work experience.
Minimum 2-3 years of relevant work experience in clinical research, in particular as clinical research associate (cra) preferred.
Previous experience with medical device or medical technology studies strongly preferred
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
Fluent english, spoken and written
