Sr Clinical Research Specialist

Johnson & Johnson•Irvine, CA

1d•Remote

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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech 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/. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for Sr Clinical Research Specialist . Purpose: Under general direction, this Senior Clinical Research Specialist will be responsible for supporting one or several clinical trials within the JJMT Neurovascular Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

Requirements

Clinical Data Management
Clinical Evaluations
Critical Thinking
Data Savvy
Ethical and Participant Safety Considerations
Good Clinical Practice (GCP)
Relationship Building
Research Documents
Safety-Oriented
Scientific Research
Standard Scientific Processes and Procedures
Technologically Savvy

Nice To Haves

Coaching
Drug Discovery Development
Industry Analysis
Medicines and Device Development and Regulation
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 JJMT Neurovascular Clinical
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
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
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed
May act as Clinical Safety Coordinator: Coordination of all safety-related activities of clinical trials; Strategic planning and coordination of all new safety initiatives; Development of clinical study safety management plan (SMP) and study-specific safety flow in accordance with internal procedures and applicable safety regulations for clinical research; Cooperation with the necessary stakeholders (clinical study team, medical, clinical sites, regulatory, data management) on safety activities related to clinical studies and guarantee adherence to the SMP; Works with data management to ensure timely database notifications to relevant parties; Coordinates the collection of required information on safety events with the clinical study team; Cooperates with cross-functional teams (Research & Development, Complaint Handling, Quality/Regulatory, Medical Affairs, Medical Safety) to ensure safety and complaint reporting compliance for each clinical study; Coordinates review of clinical safety data with the clinical study team, Medical Affairs or Medical Safety team; Ownership of the study safety inbox and coordination of timely reporting of study adverse events to competent authorities and ethics committees; Create safety reports for reporting to internal stakeholders, investigators, ethics committees and authorities; Assists in scheduling and coordination of safety adjudication process; Coordinates safety board meetings and acts as point of contact for any questions; Ensures all safety reports are directed to the appropriate staff.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits