Clinical Research Specialist - Mentor, Inc. at Johnson & Johnson

Irvine, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, MedTech, PharmaceuticalsIndustries

Requirements

Located within a commutable distance of Irvine, CA
Ability to work a Flex/Hybrid schedule with 3 days per week on-site
Willingness to travel up to 25% depending on the phase of the program
Generally manages work with supervision; independent decision-making for simple situations but requires guidance for complex situations

Responsibilities

Serves as a 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 Operating Company under supervision
Participates 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
May serve as the primary contact for clinical trial sites (e.g. site management)
Assists in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports)
Supports applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed
Coordinates and executes ordering, tracking, and accountability of investigational devices and trial materials
Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel
Interfaces and collaborates with Clinical Research Associates (CRAs)
Assists in overseeing and supports the development and execution of Investigator agreements and trial payments
Assists in 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
May provide on-site procedural protocol compliance and data collection support to the clinical trial sites
Assists in tracking assigned project budgets
May act as Clinical Safety Coordinator
Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
Develops a strong understanding of the pipeline, product portfolio and business needs
Responsible for communicating business related issues or opportunities to next management level
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices

Skills

Key technologies and capabilities for this role

Clinical TrialsR&DProject ManagementFeasibility StudiesTrial SetupTrial ConductTrial ClosureRegulatory ComplianceStudy Milestones

Questions & Answers

Common questions about this position

Is this a remote position, or do I need to work on-site?

This role follows a Flex/Hybrid schedule requiring 3 days per week on-site and you must be located within a commutable distance of Irvine, CA. It may also require up to 25% travel depending on the phase of the program.

What are the key responsibilities of the Clinical Research Specialist?

The role involves supporting clinical trials by ensuring compliance with timelines, participating in trial feasibility, setup, conduct, and closure, assisting with trial documents, coordinating investigational devices, and interfacing with sites, IRBs, vendors, and CRAs.

What salary or compensation does this position offer?

This information is not specified in the job description.

What kind of company culture is there at Johnson & Johnson MedTech?

The culture emphasizes healthcare innovation at the intersection of biology and technology to develop smarter, less invasive, more personalized treatments, while fostering strong, productive relationships across the organization.

What makes a strong candidate for this Clinical Research Specialist role?

Strong candidates will have experience supporting clinical trials under supervision, knowledge of ICH-GCP and SOPs, skills in site management, trial document development, data review, and collaboration with cross-functional teams including CRAs and vendors.

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

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