Associate Clinical Research Specialist - Irvine, United States - Johnson & Johnson

Johnson & Johnson

Verified Company

Irvine, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Under direct supervision, this Associate Clinical Research Specialist will be responsible for supporting one or several clinical trials and projects within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

POSITION DUTIES & RESPONSIBILITIES:

Under direct supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

Serves as an Associate 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 Mentor under supervision;
Supports the clinical study team in the 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;
Coordinates and executes ordering, tracking, and accountability of investigational devices and trial materials;
May interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel;
Assists the clinical study team in overseeing the development and execution of Investigator agreements and trial payments;
Assists in clinical data review to prepare data for statistical analyses and publications;
If applicable, as part of a clinical trial, may assist in providing onsite procedural protocol compliance and data collection support to the clinical trial sites;
May also be responsible for processing, tracking, and filing of study documents, and management of the Trial Master File within the clinical projects.
May support Clinical Research Associate (CRA) activities
Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;

Functional and Technical Competencies:

Basic understanding of clinical research science and processes, clinical trends, and global clinical trial regulations;
Experience supporting clinical projects within clinical/ surgical research setting, on time, and in compliance to SOPs and regulations;
Written and oral English communication skills.

Qualifications:

Education

Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.

Experience

BS with at least 6 months of relevant experience preferred.
Previous experience in clinical research or equivalent is desired.
Clinical/medical background is a plus.
Experience in Class III Medical device experience is preferred

LOCATION & TRAVEL REQUIREMENTS

Primary location for this position is Hybrid
Flex at Irvine, California.
Ability to travel approximately 1020% depending on the phase of the program.
Domestic travel may be occasionally required for training purposes (<10%).

The anticipated base salary for this position is $57,000 to $80,000.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.