Sr. Clinical Research Specialist, (Clinical Operations Start-up)

Johnson & Johnson Innovative Medicine • Irvine, CA

8d • $92,000 - $148,350

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech. Summary: The 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.

Requirements

• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
• 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.
• 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.
• Analytical Reasoning
• Clinical Data Management
• Clinical Evaluations
• Clinical Trial Protocols
• Data Savvy
• Research Documents
• Resource Management
• Safety-Oriented
• Scientific Research
• Technologically Savvy

Nice To Haves

• 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.
• Coaching
• Consulting
• Drug Discovery Development
• Good Clinical Practice (GCP)
• Medicines and Device Development and Regulation
• Persistence and Tenacity
• Regulatory Affairs Management

Responsibilities

• 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 J&J MedTech Electrophysiology
• 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)
• May assist with the development of e Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals
• May assist with maintaining the overview to assure (study) commitments are timely and properly met by coordination of specific documentation and contribution to cross-functional review of associated documents where relevant
• Supports project/study budget activities
• Mentors team members
• May perform other duties assigned as needed
• Is 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
• Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures
• 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.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 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
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level