Senior Clinical Research Specialist - Mentor, Inc.

Johnson & Johnson•Irvine, CA

46d•Remote

About The Position

At Johnson & Johnson,â we believe health is everything. Our strength in healthcare innovation empowers us to build aâ world where complex diseases are prevented, treated, and cured,â where treatments are smarter and less invasive, andâ solutions are personal.â 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.â Learn more at https://www.jnj.com 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 We are searching for the best talent for a Senior Clinical Research Specialist to support our Mentor business. The preferred location for this role is within a commutable distance of Irvine, CA however remote options within the US may be considered on a case by case basis. The role may also require up to 25% travel depending on the phase of the program. Purpose: This 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; 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.

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 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.
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,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.
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.
May act as Clinical Safety Coordinator.
Mentors team members.
Responsible for communicating business related issues or opportunities to next management level.
Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.
Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies, and procedures.
Develops a strong understanding of the pipeline, product portfolio and business needs.
Generally manages work with supervision, dependent on project complexity.
Utilizes independent decision-making for simple to advanced situations but requests guidance for complex situations.
Responsible for communicating business related issues or opportunities to next management level.
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.

Benefits

employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance
employees are eligible to participate in the Company's consolidated retirement plan (pension) and 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