Clinical Research Specialist

This 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.

Project: neurovascular trial study (research). The employee will contact multiple hospitals, collect approvals for research, recruit patients, manage a clinical study,… Will be working internationally.

Job Title: Clinical Research Specialist

Location: Diegem (on-site), Leonardo da Vincilaan 15, 1831 Machelen

Contract: long-term contract (first one until 31/12/2021, will be extended at least for 2 years)

40 HOURS request on-site

• language: English, additional European language plus

• Position requires a minimum of 1-3 years of experience

DUTIES & RESPONSIBILITIES*

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Serve 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 under supervision;
• Participate 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);
• Assist in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports), ensure registration on www.clinicaltrials.gov from study initiation through posting of results and support publications as needed;
• Coordination and execution of orders, tracking, and managing investigational products and trial materials;
• Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel;
• Assist in overseeing the development and execution of Investigator agreements and trial payments;
• Assist in clinical data review to prepare data for statistical analyses and publications;
• If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or closeout visits based on study need;

•       If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center;

•       Responsible for communicating business-related issues or opportunities to the next management level. Function as a reliable trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;

•       Assist in tracking assigned project budgets;

•       Develop a strong understanding of the pipeline, product portfolio, and business needs;

•       Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;

•       Performs other duties assigned as needed;

•       Generally manages work with supervision, dependent on project complexity. Independent decision-making for simple situations but required guidance for complex situations.

EXPERIENCE AND EDUCATION*

Education

·       Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.

Experience                 

·       BS with at least 2 years, MS and PhD with at least 1 year of relevant experience preferred.

·       Previous experience in clinical research or equivalent is desired.

·       Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).

·       Clinical/medical background a plus.

·       Medical device experience a plus.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*

Functional and Technical Competencies:

•       Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations;

•       Proven track record in supporting clinical projects within clinical/ surgical research setting, on time, and in compliance to SOPs and regulations;

•       Presentation and technical writing skills;

•       Written and oral communication skills.

Leadership Competencies:

Leadership required in alignment with J&J Leadership Imperatives:

•       Connect - Develop collaborative relationships with key internal and external stakeholders.

•       Shape - Actively participate in departmental process improvement activities. 

•       Lead - Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.

•       Deliver - Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations.