Clinical Research Associate II - Ghent, Flemish Region

Alleen voor geregistreerde leden Ghent, Flemish Region, België

22 uur geleden

42.000 € - 65.000 € (EUR) per jaar *

* Dit salarispakket is een schatting gemaakt door beBee

Functieomschrijving

Primarily a training and development role, this position will support and observe clinical site monitoring services both inhouse and in the field whilst developing CRA skills and knowledge. This role will have exposure and training in all aspects of the clinical site monitoring services whilst providing monitoring and site management activities for full-service studies assessing for protocol, SOP, and regulatory compliance. Responsibilities include site management activities to help drive investigative site and patient recruitment, compliance, and oversight. Conduct remote data review, support data query and closure activities, support Risk Based Monitoring (RBM) activities, assess data collection and (regulatory) document collection, perform remote and onsite activities for investigational sites including site contacts, qualification, initiation, monitoring and close out visits under supervision and/or independently and in accordance with corporate, sponsor and regulatory (ICH GCP and other) standards and guidelines. Represents the corporation by maintaining collaborative relationships with stakeholders.

Positions available: 1 (remote within Belgium)

Site Management

Conducts and documents remote site contacts which could include remote site initiation, monitoring and close out visits. Documents activities per SOPs and study guidance
Conducts and documents onsite activities such as feasibility, qualification, initiation, monitoring and close out visits under supervision. Documents activities per SOPs and study guidance
Conduct remote data review of EDC, CTMS, RBM and other clinical systems to ensure alignment with SOPs, study guidelines and GCP best practices. Identify trends within and across study sites and escalate findings appropriately.
Routinely reviews the site section of the TMF for accuracy, timeliness, and completeness. Requests new/updated documents from the site/primary assigned CRA, as required
Support CRA II, Snr CRA and Lead CRA's in day-to-day study management activities.
Remotely monitor, resolve and/or facilitate resolution of queries arising out of regular and/or safety reviews, adverse events, and other data management activities throughout the trial
Coordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project life cycle
Supports preparation for audit and required follow-up actions.

Site Setup and Startup Support

Identify and recruit site investigators, coordinate the movement and delivery of trial materials, samples, tests, and forms, including investigational medicinal product, protocols, SOPs, CRFs, project documents, forms, and support tools.
Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria

Training and Development

Successfully complete CRA development track activities and milestones
Develop and demonstrate competencies required to fulfill the role of a CRA
Support and observe primary assigned CRAs at both onsite and remote visits
Support Lead CRA's with remote site management activities
Participate on all study related activities, including but not limited to trainings, team meetings and provide any necessary updates to the study team

Qualifications

The successful candidate will possess a minimum of a college diploma/degree and 1-3 years related experience.
SoCRA, CCRA and/or ACRP certification/designation is an asset.
The successful candidate must exhibit the following skills: self-motivation with strong communication skills and a commitment to achieving positive results.
Strong attention to detail and keenness to understand the importance of building collaborative relationships to achieve results.
For one CRA position supporting Flemish sites in Belgium, Dutch language skills are required

Working Conditions

Home-based
Regular travel

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.