Clinical Trial Specialist

Antler; Santa Clara (CA); On-site; USD 106,000 - 170,000; Full time

Benefits offered by this job

Vacation – 120 hours/year

Parental Leave – 480 hours/year

401(k) plan

Job summary

Johnson & Johnson MedTech is recruiting a Clinical Trial Specialist – MedTech. The role is based in Cincinnati, OH or Santa Clara, CA with a full onsite schedule (5 days/week).

You will manage trial sites, monitor adherence to SOPs and GCP, support site activation, and help ensure data integrity throughout the trial lifecycle. Preferred candidates hold a life sciences degree and 3+ years in clinical trials, with strong planning, communication and regulatory knowledge.

Qualifications

• Bachelor degree in Life Science, Physical Science, Nursing or Biological Science preferred.
• 3+ years in clinical trials; MS with 2 years or PhD with 1 year related experience.
• Experience in medical device monitoring is preferred.
• Strong computer skills with Microsoft Office & clinical systems.

Responsibilities

• Act as primary local contact for assigned sites for specific trials.
• Lead executional aspects of sponsored trials with oversight.
• Participate in site feasibility and pre-trial visits.
• Ensure site staff are trained and training records are complete.
• Prepare trial sites for close-out and ensure data integrity.

Skills

Presentation skills

Influencing skills

Organizational skills

Communication skills

Problem solving

Education

Bachelor degree in Life Science or related field

Tools

Microsoft Office

Clinical trial systems

Job description

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.

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).

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

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)).

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