Job Specifications
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds....
ClinChoice is searching for a Clinical Research Associate II to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines where you will work in a hybrid model in Diegem. In this you will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.
Main Job Tasks and Responsibilities:
Serves as a Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones, for Company Electrophysiology under supervision.
Participates in the feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures.
May serve as the primary contact for clinical trial sites (e.g. site management).
Assists in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports).
Supports applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed.
Coordinates and executes ordering, tracking, and accountability of investigational devices and trial materials.
Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
Interfaces and collaborates with Clinical Research Associates (CRAs).
Assists in overseeing and supports the development and execution of Investigator agreements and trial payments.
Assists in clinical data review to prepare data for statistical analyses and publications.
May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.
May provide on-site procedural protocol compliance and data collection support to the clinical trial sites.
Assists in tracking assigned project budgets.
Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.
Should develop a strong understanding of the pipeline, product portfolio and business needs.
Generally manages work with supervision. Independent decision-making for simple situations but requires guidance for complex situations.
Responsible for communicating business related issues or opportunities to next management level.
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Performs other duties assigned as needed.
May act as Clinical Safety Coordinator:
Coordination of all safety-related activities of clinical trials.
Strategic planning and coordination of all new safety initiatives.
Development of clinical study safety management plan (SMP) and study-specific safety flow in accordance with internal procedures and applicable safety regulations for clinical research.
Cooperation with the necessary stakeholders (clinical study team, medical, clinical sites, regulatory, data management) on safety activities related to clinical studies and guarantee adherence to the SMP.
Works with data management to ensure timely database notifications to relevant parties.
Coordinates the collection of required information on safety events with the clinical study team.
Cooperates with cross-functional teams (Research & Development, Complaint Handling, Quality/Regulatory, Medical Affairs, Medical Safety) to ensure safety and complaint reporting compliance for each clinical study.
Coordinates review of clinical safety data with the clinical study team, Medical Affairs or Medical Safety team.
Ownership of the study safety inbox and coordination of timely reporting of study adverse events to competent authorities and ethics committees.
Create safety reports for reporting to internal stakeholders, investigators, ethics committees and authorities.
Assists in sche
About the Company
ClinChoice is a leading global full & functional service CRO, renowned for its exceptional product development and lifecycle management capabilities across the pharmaceutical, biotechnology, medical device, and consumer health sectors. With three decades of proven expertise and outstanding results, we excel in delivering top-tier services.
Our deep regulatory expertise, clinical trial execution, and robust pharmacovigilance and biometrics capabilities position us as a trusted partner in global markets. ClinChoice proudly mai...
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