Senior Clinical Trial Specialist

Johnson & Johnson•Cincinnati, OH

9d•$109,000 - $174,800

About The Position

Clinical Affairs of Robotics and Digital Solutions, Johnson & Johnson MedTech, is recruiting a Senior Clinical Trial Specialist. This role is responsible for leading operational activities of clinical trials well as encouraging strong, positive relationships with colleagues across the organization. The Senior Clinical Trial Specialist ensures 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. The Senior Clinical Trial Specialist will conduct site monitoring activities for clinical trials as well as operational aspects of studies. 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.

Requirements

A minimum of a Bachelor’s degree and/or equivalent University degree is required; focused degree in Life Science, Physical Science, Nursing or Biological Science discipline is preferred.
A minimum of 4 years of professional work experience (6 years preferred)
Previous clinical research experience required.
Previous medical device site monitoring or equivalent experience required.
Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.
Experience and knowledge working with computer systems (Microsoft Office – Excel, Word, Power Point and Outlook).
Strong digital literacy in appropriate software and related company clinical systems.
Good understanding of clinical research science and processes along with an understanding of clinical trends and global clinical trial regulations.
Proficient in speaking and writing the country language, English.
Presentation and influencing skills.
Strong organizational skills (e.g., able to handle multiple sub-projects and tasks simultaneously and consistently meet all associated metrics).

Nice To Haves

Medical background preferred.
Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).

Responsibilities

Executes and leads clinical trials, ensuring compliance with timelines and study milestones.
Oversees/drives 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 SOPs
May serve as the primary contact for trial sites (i.e., site management).
Develops clinical trial documents (e.g., study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports).
Ensures applicable trial registration (e.g., on www.clinicaltrials.gov ) from study initiation through posting of results and supports publications as needed.
Manages/coordinates ordering, tracking, and accountability of investigational devices and trial materials.
Partners and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
Interfaces with, collaborates with and is responsible for Clinical Research Associates (CRAs).
Coordinates 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.
Ensure site staff are trained, and the corresponding training records are complete and accurate at any time point during all trial phases.
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.
May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS), with collaborative relationships with all relevant Clinical partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc.), contributing to cross-functional alignment.
May provide on-site procedural protocol compliance and data collection support to clinical trial sites.
Independently solves problems arising during clinical study execution, and will seek guidance for more complex problems, as needed.
Responsible for communicating business related issues or opportunities to next management level.
Knows, understands, incorporates, and follows all applicable laws and regulations relating to J&J business activities, and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
May be asked to provide additional support for the trial team, as needed.

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.
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year