Principal Clinical Research Associate – Shockwave
Location
California + 1 moreAll locations: California | Minnesota
Posted
7 days ago
Salary
$125K - $201.3K / year
Seniority
Mid Level
Job Description
Principal Clinical Research Associate – Shockwave
Johnson & Johnson
• Responsible for organizing, communicating and evaluating team objectives for clinical studies. • Participates in study design and study preparation activities, as applicable. • Develops and revises clinical trial documentation including clinical trial protocol development, case report form (CRF) development, IRB/Ethics submissions. • Participates or leads the process to evaluate and select potential investigators and sites. • Participates or leads the process to evaluate and select potential vendors as applicable. • Conducts or oversees site visits as required (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct. • Develops and revises site training tools, interprets clinical data, manages investigational sites, develops tracking tools and performs other clinical activities as needed during clinical study conduct. • Leads clinical study teams focused on conducting clinical programs consistent with applicable regulations, guidelines, and policies. • Manages project timelines and vendor performance to meet departmental and corporate goals. • Monitors and tracks clinical trial progress and provides status update reports. • Manages study budget, payment process and reconciliation of invoices for all clinical trial vendors including investigative sites when applicable. • Oversees work produced by junior clinical team members. • Manages all clinical trial vendors (e.g., IRB, IVRS, central/core labs, such as angiogram, ultrasound, or central ECG). • Analyzes and evaluates clinical data gathered during research. • Leads, prepares and reviews project and study-related documents including: informed consent forms, investigational brochures, case report forms, monitoring plans, synopses, protocols and amendments, and other appropriate sections for studies conducted under Investigational Device Exemption (IDE) or 510(k) application. • Responsible for authoring internal documents and clinical study reports and assisting with clinical evaluation reports. • Develops and revises annual, interim, and final reports and clinical sections of Pre- or Post-Market Approval submissions. • Coordinates the design, format and content of CRFs, study guides, study reference binders, and forms including participating in the EDC and IVRS specification process and UAT. • Coordinates and manages Investigational Product including overall accountability and reconciliation. • Responsible for selection of CRO study staff and coordinating training including documentation. • Leads the review of clinical data at the CRF, data listing, and report table levels. • Represents Clinical Affairs at the Project Team level for individual studies, as appropriate • Identifies and escalates site, vendor and study related issues to supervisor, as appropriate • Oversees clinical and adverse event data evaluation during the conduct of the study and for completion of clinical study reports. • Working knowledge of CEC and DSMBs. • Manages training of investigators, site staff, and SWMI clinical staff. • Oversees quality by maintaining compliance, reviewing device complaints, reviewing audit reports and implementing corrective and preventative actions. • Other duties as assigned.
Job Requirements
- Bachelor’s Degree or equivalent experience in a scientific field of study
- Minimum 10 years’ experience directly supporting clinical research or relevant experience in medical/scientific area.
- Minimum 1 year in a role directly managing trials and projects, 2-3 years preferred.
- Ability to travel 10-20% domestically and internationally.
- Thorough knowledge of Good Clinical Practice (GCP) is required.
- Working knowledge of GCP, FDA, ISO and other applicable regulations.
- Experience with EDC Data Management Systems.
- Basic understanding of peripheral and coronary artery disease and therapies preferred.
- Knowledge and experience in supporting device pre- and/or post-market clinical studies is required, including experience running IDE trials.
- ACRP or SOCRA clinical research certification is preferred.
- Able to manage multiple project teams.
- Ability to work in a fast-paced environment while managing multiple priorities.
- Must have excellent verbal and written communication skills.
- High attention to detail and accuracy.
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
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