Job Description - Senior Clinical Research Specialist (2506237640W)
Senior Clinical Research Specialist - 2506237640W
Description
The neurovascular team at Johnson & Johnson MedTech is currently seeking a Senior Clinical Research Specialist who will be responsible for supporting multiple clinical trials within the Clinical R&D Department while fostering strong, positive relationships with co-workers across the organization. This role will operate on a hybrid schedule (2-3 days/week in-office) and the candidate is required to live within a commutable distance of either Galway (IE), Diegem (BE), or Zuchwil (CH) ( Remote candidates may be considered in some cases ).
Every six seconds someone dies from a stroke. Stroke can be caused either by a clot obstructing the flow of blood to the brain (ischemic stroke) or by a blood vessel rupturing and preventing blood flow to the brain (hemorrhagic stroke). J&J MedTech is committed to changing the trajectory of stroke by providing physicians with innovative technologies to push the boundaries of what’s possible in neurovascular intervention. J&J MedTech offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke.
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:
Support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones;
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;
Is 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 provide on-site procedural protocol compliance and data collection support to the clinical trial sites;
Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated;
Contributes to delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
Supports project/study budget activities;
Mentors team members;
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, dependent on project complexity. Independent decision-making for simple and more advanced 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;
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures;
May act as Clinical Safety Coordinator for safety-related activities in clinical trials;
Performs other duties assigned as needed;
EXPERIENCE & EDUCATION
Education:
Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
Experience:
BS with at least 4 years, MS with at least 3 years, PhD with at least 2 years of relevant experience preferred.
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.
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 delivery of clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations;
Good presentation and technical writing skills;
Good written and oral English communication skills;
Ability to lead small study teams to deliver critical milestones, as may be assigned. Leadership required in alignment with J&J Leadership Imperatives:
Connect - Develop collaborative relationships with key internal and external stakeholders.
Shape - Make recommendations for and 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.
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