At Johnson & Johnson, we all belong.
This Senior Clinical Research Specialist will be responsible for supporting multiple clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
POSITION 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 Senior 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 JnJ MedTech Neurovascular
- Generally, manages work with some supervision, dependent on project complexity. Independent decision-making for simple and some more advanced situations, but requires guidance for complex situations
- Oversight/execution of 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
- Ability to serve as the primary contact for multiple clinical trial sites (e.g., site management)
- Ability to serve as the primary contact and liaison for clinical trial vendor(s), driving and tracking achievement of vendor-related study milestones
- Contribute towards development and drafting of clinical trial documents (e.g., study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual report)
- Ensure registration on www.clinicaltrials.gov from study initiation through posting of results and support publications as needed
- Management/oversight of ordering, tracking, and accountability of investigational products and trial materials
- Develop strong collaborative relationships with site personnel, IRBs/ECs, contractors/vendors, and company personnel
- Oversee the development and execution of Investigator agreements and trial payments
- Responsible for 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 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
- If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center
- Contribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated
- Demonstrate 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)
- Responsible for communicating business related issues or opportunities to next management level
- Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
- Support project/study budget activities as assigned
- 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
- Perform other duties assigned as needed
Qualifications
Education:
- Minimum of a Bachelor’s Degree required, preferably in Life Science, Physical Science, Nursing, or Biological Science; Advanced degree preferred
Required:
- BS with at least 4 years, MS with at least 3 years, PhD with at least 2 years of relevant clinical research experience required
- Previous experience in clinical research or equivalent
- 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 communication skills
- Ability to travel up to approximately 25% depending on the phase of the program
Preferred:
- Medical device experience highly preferred. Neurovascular/stroke experience is a plus
- Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV)
- Experience with both CRO & Sponsor side desired
The anticipated base pay range for this position is $89,000 to $130,000.
