Job Function: R&D Operations
Job Sub Function: Clinical Trial Support
Job Category:Professional
All Job Posting Locations:Cincinnati, Ohio, United States of America, Santa Clara, California, United States of America
Job Description:Johnson & Johnson MedTech Clinical advances innovation through clinical studies that evaluate how technologies perform in real-world healthcare settings with clinicians, workflows, and patients. The evidence generated through these studies helps improve products, build confidence in their safety and effectiveness, and supports better experiences and outcomes for healthcare teams and the patients they serve.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
Johnson & Johnson MedTech is currently recruiting for a
Clinical Trial Specialist- MedTech. The position can be located in
Cincinnati, OH or Santa Clara, CA. This position requires the candidate to work a full onsite schedule with 5 days per week in the office.
Purpose:The Clinical Trial Specialist is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and applicable regulations and guidelines from study start-up through clinical study report. Responsibilities may include assisting with site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring, close-out activities, and additional study-specific activities at the trial site. The Clinical Trial Specialist may lead portions of the clinical operations execution in partnership with the Clinical Trial Leader.
Role and Responsibility- Act as primary local company contact for assigned sites for specific trials.
- Leads executional aspects of sponsored clinical trials with appropriate oversight.
- Participate in site feasibility and/or pre-trial site assessment visits.
- Attend/participate in investigator meetings as needed.
- Complete activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies.
- May develop clinical trial documents, such as monitoring plans, informed consent.
- Implement of analytical risk-based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
- Works with, collaborates with and may oversee Clinical Research Associates (CRAs).
- Ensure site staff are trained, and the corresponding training records are complete and accurate at any time point during all trial phases.
- Work in close collaboration with Clinical Research Manager for the activities during site activation phase to speed up the process and activate the site in shortest possible timeframe.
- Ensure site staff complete data entry and resolve queries within expected timelines.
- Ensure accuracy, validity and completeness of data collected at trial sites
- Ensure that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
- Oversee ordering, tracking, and accountability of investigational devices and trial materials.
- Maintain complete, accurate and timely data and essential documents in relevant systems used for trial management.
- Fully document trial related activities, in particular monitoring. Writes visit reports and follow-up letters in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate partners.
- Review study files for completeness and ensures archiving retention requirements are met, always including storage in a secure area.
- Attend regularly scheduled team meetings and training.
- Follow relevant training requirements. Develops therapeutic knowledge sufficient to support role and responsibilities.
- Work closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring and other visit types,
- Prepare trial sites for close out, conduct final close out visit.
- Track costs at site level and ensure payments are made, if applicable.
- Establish and maintain good working relationships with internal and external partners, investigators, trial coordinators and other site staff.
- Act as a point of contact in site management practices.
- Contribute to process improvement and training.
- Lead and/or participate in special initiatives as assigned.
- May assume additional responsibilities or special initiatives such as "Champion" or Subject Matter Expert".
Qualifications and Requirements:- A Bachelor Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
- 3+ years of experience working in clinical trials is required; MS with at least 2 years, PhD with at least 1 year of related experience.
- Previous clinical research experience is required.
- Good understanding of clinical research science and processes along with an understanding of clinical trends and global clinical trial regulations is required.
- Previous experience in medical device monitoring is strongly preferred; requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.
- Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
- Ability and willingness for up to 40% travel (mostly domestic) is required.
- Clinical/medical background preferred.
- Requires experience and knowledge working with computer systems (Microsoft Office - Excel, Word, Power Point and Outlook).
- Strong computer skills in appropriate software and related company clinical systems.
- Presentation and influencing skills.
- Strong organizational skills (e.g., able to manage multiple sub-projects and tasks simultaneously and consistently meet all associated deadlines).
#LI-Onsite
Required Skills:Preferred Skills:Business Behavior, Business English, Clinical Data Management, Clinical Trials Operations, Execution Focus, Laboratory Operations, Mentorship, Proactive Behavior, Problem Solving, Process Improvements, Project Support, Regulatory Environment, Regulatory Inspections, Research and Development, Research Ethics, Study Management, Time Management
The anticipated base pay range for this position is :$92,000.00 - $148,350.00
For Bay Area:
$106,000.00 - $170,200.00
Additional Description for Pay Transparency:
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)).
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
