Clinical Research Specialist (senior)

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

We are currently recruiting a Clinical Research Specialist (senior) to join our contingent workforce. You will be working in the EMEA Clinical Fran of J&J in Diegem, Belgium. This will be an initial contract opportunity, starting May 23, 2022 until December 31, 2022, with high possibility of an extension (for another year).

This is both on site / off site (50/50) with on site access to Diegem, Belgium.

Project Scope:

• This Senior Clinical Research Specialist 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.
• Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines

Your Responsibilities:

• Oversees/executes 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)
• Contributes towards 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
• Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials
• Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel
• Interfaces, collaborates and oversees Clinical Research Associates (CRAs);
• Oversees and supports the development and execution of Investigator agreements and trial payments
• Responsible for 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 contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects
• May assist with the development of e Post-Market Clinical Follow-up (PMCF) Plans and PMCF

Minimum requirements: 

• Previous experience in clinical research or equivalent is required.
• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
• Clinical/medical background is a plus.
• Medical device experience is highly preferred.
• Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations
• Proven track record in supporting delivery of clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations
• Good written and oral English communication skills
• Ability to lead small study teams to deliver critical milestones, as may be assigned.

If you meet our requirements and are interested in hearing more about our Clinical Research Specialist (senior) role, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!