Clinical Research Associate

Website Harmony Clinical Research

Harmony Clinical Research is looking for an additional CRA to strenghten their team. You will become a member of a dynamic, enthusiastic team and get the opportunity to take up broad responsibilities for different types of trials and therapeutic areas and for different international clients.

The CRA will oversee the progress of a clinical trial, and should ensure that it is conducted, recorded, and reported to a high quality in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). He/she must verify whether the rights, safety and well-being of the subjects are protected and whether the reported trial data are accurate, complete and credible.

Responsibilities

Ø  To act as main point of communication between sponsor, site staff and any third party.
Ø  To ensure that the study is conducted and documented in compliance with the approved protocol/amendment(s), with GCP and with all applicable regulatory requirements.
Ø  To work according to the applicable quality management system (HarmonyCR or client).

Tasks

Ø  To perform submissions to Ethical Committees and Regulatory Authorities: initial submissions, amendments and safety information amongst other.
Ø  To prepare, conduct and report feasibility studies.
Ø  To prepare, conduct and report site selection, initiation, monitoring and close-out visits.
Ø  To coordinate contract negotiations between client and site.
Ø  To build and maintain good collaboration with investigators and site personnel.
Ø  To ensure that sites are prepared and ready to conduct the study in relation to training, study supplies, medication amongst other.
Ø  To verify source data and CRF on completeness and correctness.
Ø  To monitor the conduct and progress of the study.
Ø  To collect, maintain and archive all required essential documents.
Ø  To verify IP ordering, shipments, storage and accountability.
Ø  To verify whether safety reporting requirements are met: SAE, SUSAR, line listings.
Ø  To report adequately and timely to the appropriate person on the progress of the trial and on any item requiring follow-up.
Ø  To coordinate communication between site staff and any other party.
Ø  To participate in international study teams.
Ø  To work, when possible, in a pro-active /anticipating manner to avoid problems from occurring.
Ø  To work in accordance with the specified quality system for the study and to adhere to the study timelines.
Ø  To coordinate audit and inspection preparation activities when required and ensure that corrective and preventive actions are implemented
Ø  Maintain personnel dossier (training records and CV) up to date as required by HarmonyCR
Ø  Any other task that may be requested as far as can reasonably be expected.

Job criteria

Ø Education: Degree in life science, preferably higher vocational education or academic degree

Ø Experience: Preferably at least 1 year experience in (international) clinical research as CRA

Ø Languages: Fluent in English, Dutch and French; another European language is an asset

Ø IT literacy: Microsoft Office (Outlook, Word, Excel, Powerpoint), internet
Any experience with CTMS-, eCRF systems is an advantage

Ø Other requirements: Excellent knowledge of ICH GCP and all applicable regulatory requirements

Ø Personal skills:

Diplomatic and tactful
Communicative: oral as well as in writing (one-on-one as well as in group)
Team player
Problem solver and analytical capabilities
Accurate and well organized
Detail oriented
Working independently
Stress resistant
Willingness to travel frequently, also to other countries (mainly The Netherlands)

To apply for this job email your details to hr@harmony-cr.com

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