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

Irvine, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, MedTech, PharmaceuticalsIndustries

Requirements

Ability to commute to Irvine, CA or work remotely within the US (case by case)
Willingness to travel up to 25% depending on program phase
Expertise in ICH-GCP, applicable legislation, and Company Standard Operating Procedures

Responsibilities

Serve as Senior Clinical Research Specialist within Clinical R&D to support execution of company-sponsored clinical trials, ensuring compliance with timelines and milestones
Oversee/execute feasibility, selection, set up, conduct, and closure of clinical trials within allocated countries
Serve as primary contact for clinical trial sites (e.g., site management)
Contribute to development of clinical trial documents (e.g., study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports)
Support applicable trial registration (e.g., www.clinicaltrials.gov) from initiation through results posting and publications
Manage and oversee ordering, tracking, and accountability of investigational devices and trial materials
Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel
Interface, collaborate, and oversee Clinical Research Associates (CRAs)
Oversee and support development and execution of Investigator agreements and trial payments
Perform clinical data review to prepare data for statistical analyses and publications
Perform monitoring activities including site qualification, initiation, interim monitoring, or close-out visits as needed
Contribute to development and delivery of global evidence generation strategies (EGS) and evidence dissemination strategies (EDS)
Provide on-site procedural protocol compliance and data collection support to clinical trial sites
Contribute to critical assessment of literature and interpretations/disseminations of generated evidence
Contribute to delivery of assigned clinical projects through partnership with study core team (on time, within budget, compliant with regulations/SOPs)
Assist with development of e Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports within timelines and review/update as needed

Skills

Key technologies and capabilities for this role

Clinical TrialsR&DProject ManagementFeasibility StudiesTrial ExecutionStudy ManagementRegulatory ComplianceClinical Research

Questions & Answers

Common questions about this position

Is this position remote or does it require being in the office?

The preferred location is within a commutable distance of Irvine, CA, but remote options within the US may be considered on a case-by-case basis. The role may also require up to 25% travel depending on the phase of the program.

What are the main responsibilities of this Senior Clinical Research Specialist role?

The role involves supporting clinical trials by overseeing feasibility, site selection, setup, conduct, and closure; contributing to trial documents; managing investigational devices; interfacing with sites, IRBs, vendors, and CRAs; and reviewing clinical data.

What salary or compensation does this position offer?

This information is not specified in the job description.

What kind of experience or skills are needed for this role?

Candidates need expertise in clinical trial execution, including ICH-GCP compliance, site management, development of trial documents like protocols and CRFs, oversight of CRAs, and clinical data review.

What makes a strong candidate for this Senior Clinical Research Specialist position?

A strong candidate will have experience supporting clinical trials in R&D, fostering relationships across the organization, and handling site management, trial documents, vendor oversight, and data review while ensuring compliance with ICH-GCP and company procedures.

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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