Associate Site Manager (Clinical Research Associate) at Johnson & Johnson

Toronto, Ontario, Canada

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Not SpecifiedCompensation

Entry Level & New GradExperience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Bachelor of Science, R.N., or equivalent degree in Biological Sciences preferred
Minimum of 1 year experience in onsite and offsite (remote) monitoring; however, other relevant experiences and skills may be considered
Pharmaceutical industry clinical research trial experience preferred
Analytical/risk-based monitoring experience is highly preferred
Knowledge of several therapeutic areas is an asset (preferably including oncology)
In-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements
Ability to operate and use various systems and databases (e.g., CTMS, EDC, TMF, various dashboards/metrics, IWRS, safety reporting)
Strong communication and influencing skills to effectively manage study sites both remotely and face-to-face
Strong team member and self-starter with the ability to work independently
Ability to establish a home office
Fluent in the English language
Travel: 30-50%

Responsibilities

Be the primary point of contact for the study site; liaison with study teams
Actively identify and drive patient recruitment strategies at assigned sites
Monitor the study/site according to GCP standards and J&J GCO SOPs, both on-site and with remote contacts
Perform source document verification, Investigator Site File (ISF) review and accurate drug accountability
Provide site training, during site initiation and ongoing, to ensure compliance with all required regulations, SOPs, trial-specific tools and systems, and specialized procedures
Ensure resolution of site-specific issues and partner closely with investigator and site staff to meet all study timelines
Work closely with the local study operations team to resolve protocol and site-specific issues
Use and maintain the clinical trial tracking system (CTMS) and update the electronic Trial Master File (TMF) as required

Skills

Clinical Trial Management

Patient Recruitment

Site Management

Liaison

Communication

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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