Clinical Data Research Associate
4 weeks ago
This is a full-time job.
The CRA is responsible for ensuring that the conduct of a clinical trial at selected Investigational Sites is according to the currently approved protocol/amendments, ICH GCP guidelines, the applicable Standard Operating Procedures (SOPs) and the applicable laws and regulations.
The most important responsibility is to ensure that the subjects' rights are respected and that all collected clinical trial data are accurate, complete, and verifiable from source documents.
Acknowledges, follows& ensures compliance with the Company's Quality and Information Security Management Systems, ICH GCP guidelines, applicable local and international legislation, including data protection legislation, as well as any amendments or updates the above
-Conducts pre-study visits at potential investigational sites, to perform the study related feasibility and/or selection activities and evaluate their resources and facilities
-Collaborates with the Regulatory Affairs Department and concerned Clinical Operations staff for clinical submissions and contracts respectively for:
Managing Hospital IEC study submissions and approvals with follow through to ensure successful outcome
Preparation of study contracts & relevant files to be submitted for the study financial management acceptance, as required by the applicable local legislation
-Fully explains the purposes, set-up, and procedures of the clinical trial to the Investigators and is responsible for training and assisting them in the conduct of clinical trials
-Prepares and updates the Clinical Trial Files throughout the study and ensures the proper collection of essential documents and other study-related documents during the trial
-Ensures that the Sites are supplied with adequate study medication, verifies that drug accountability is performed correctly and ensures the drug's safe shipment, storage, dispensing, return and destruction, as applicable
-The CRA is responsible for adequate monitoring of the clinical trial conduct at the Investigational Sites (e.g., performs monitoring visits at the Sites) during which he/she:
Verifies that Investigators' qualifications and resources remain adequate throughout the trial period
Reviews and verifies the data reported in the eCRF against source data, according to the monitoring plan which determines the depth and extend of source data verification
Checks the storage and adequacy of clinical trial supplies
Checks that all submissions, reports, notifications and applications to the IEC/IRB or Regulatory Authorities have been made by the Investigator in a timely manner
Prepares reports to document all discussions, measures and actions made during a monitoring visit, telephone contact or remote monitoring. The CRA also sends summary of these reports to the Investigators
-Participates in study specific conference calls and meetings to review progress of ongoing clinical trials; In case of an audit or regulatory inspection, the CRA is responsible for informing and preparing the Site and facilitating the procedure. The CRA works with the appropriate study team members and Quality (QA) in order the corrective actions are in place and performed as soon as possible
-Collaborates with the CRA Manager and Clinical Operations Manager to develop feasibility evaluation questionnaires, contact the Investigators to collect feasibility-related information, perform site screening and selection
-Manages timely subject enrolment and quality data collection
-Closes down study sites on completion of the trial
-Participates in departmental planning sessions, and SOP development, if required
-Provides coaching, mentoring and management to the newly appointed and/or inexperienced CRAs to ensure that their role and contribution is optimized
Bachelor's and/or master's degree (preferably in Health Sciences)
-Previous Work Experience desirable:
~6-12 months' work experience as a CRA
-Excellent command of English and French both oral and written
-Attendance of an ICH GCP training course (desirable)
-Good computer skills
-Ability to communicate diplomatically, but also effectively with study Site personnel
-Ability to deal adequately with stressful situations, flexible timelines and work pressure
-Ability for frequent international and local travelling, including evenings and overnight stays
Join us to be part of a multidisciplinary team of highly skilled scientists and healthcare professionals in the forefront of Clinical Research within a friendly work environment.
In Heads we consider Data Protection an integral part of our operational business principles and are committed to respecting your privacy. For information on how we process your personal data please visit our Privacy Notice to Candidates:
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