Associate Site Manager (CRA - Monitor de Pesquisa Clinica I) at Johnson & Johnson

São Paulo, State of São Paulo, Brazil

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Not SpecifiedCompensation

Entry Level & New GradExperience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, Clinical ResearchIndustries

Requirements

Entry level role with typically 0-2 years of experience
Serves as primary contact point between Sponsor and Investigational Site
Ensures inspection readiness through compliance with clinical trial protocol, company SOPs, GCP, and applicable regulations/guidelines from study start-up to site closure
Some supervision from Senior Site Manager or Lead Site Manager

Responsibilities

Acts as primary local company contact for assigned sites for specific trials
May participate in site feasibility and/or Site Qualification Visit
Attends/participates in investigator meetings as needed
Executes activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards), and site/study close-out according to SOPs, Work Instructions (WIs), and policies
Implements analytical risk-based monitoring model at the site level and works with site to ensure timely resolution of issues found during monitoring visits (occasionally with assistance/oversight from Lead Site Manager or LTM)
Ensures site staff are trained and corresponding training records are complete and accurate at any time during all trial phases
Collaborates closely with LTM and central study team for site activation activities to speed up the process and activate sites in the shortest possible timeframe
Contributes to site level recruitment strategy and contingency planning/implementation in partnership with other functional areas
Ensures site study supplies (e.g., Non-Investigational Product (IP), lab kits) are adequate for trial conduct
Ensures clinical drug supplies are appropriately used, handled, stored, and returns are accurately inventoried and documented
Arranges for the appropriate destruction of clinical supplies
Partners with Local Trial Manager (LTM), Clinical Trial Assistant (CTA), and Trial Delivery Leader (TDL) for overall site management and trial-related activities
May contribute to process improvement and training

Skills

GCP

Clinical Trial Monitoring

Site Management

SOP

Site Initiation

Site Close-out

Subject Recruitment

Inspection Readiness

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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