Senior Clinical Research Specialist

Job not on LinkedIn

November 25

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $92k - $148.3k / year

⏰ Full Time

🟠 Senior

🔬 Research Analyst

🦅 H1B Visa Sponsor

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Johnson & Johnson

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Healthcare Insurance • Pharmaceuticals • Biotechnology

Johnson & Johnson is a multinational corporation focused on innovating across multiple sectors of healthcare and medicine. With a commitment to redefining healthcare, the company merges science and technology to address complex diseases through its divisions in innovative medicine and medical technology. Its areas of focus include oncology, immunology, neuroscience, and specialty ophthalmology, as well as interventional solutions and orthopaedics. J&J is dedicated to advancing global health equity and environmental sustainability while fostering innovation, diversity, and inclusion in the workplace. The company strives to provide solutions that connect health and care for providers, patients, and communities worldwide.

10,000+ employees

Founded 1886

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🧬 Biotechnology

📋 Description

• Serves 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 operating company. • 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. • Contributes towards development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports,etc.). • Supports applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed. • Manages and 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. • Prepares 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 delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments.

🎯 Requirements

• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required ; Advanced Degree strongly preferred • At least 4+ years (2+ with Advanced Degree) of relevant field-based Clinical Research experience beyond monitoring and/or lab work required • Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations required • Combination of CRO & In-House experience highly desired • Medical device experience highly desired • Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV, etc.) • 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 English communication skills. • Ability to travel approximately 20-25% depending on the phase of the program.

🏖️ Benefits

• medical • dental • vision • life insurance • short- and long-term disability • business accident insurance • group legal insurance • consolidated retirement plan (pension) • savings plan (401(k)) • Vacation –120 hours per calendar year • Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year • Holiday pay, including Floating Holidays –13 days per calendar year • Work, Personal and Family Time - up to 40 hours per calendar year • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child • Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member • Caregiver Leave – 10 days • Volunteer Leave – 4 days • Military Spouse Time-Off – 80 hours