Senior Clinical Research Associate (West Coast)

Sitero; California; Teletrabalho; USD 110 000 - 140 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Healthcare

Retirement benefits

Competitive compensation

Resumo da oferta

Sitero is seeking a Senior CRA (West Coast) for remote oversight of clinical trials across sites. Responsibilities include site start-up, initiation, monitoring, and closeout with up to 80% travel as needed.

You will collaborate with Global Project Lead and CTM to ensure timely site activation, feasibility, and regulatory compliance. Essential qualifications include at least 3 years independent CRO monitoring experience and a minimum of 5 years CRO experience.

Qualificações

• 5+ years of CRO experience with at least 3 years of independent drug trial monitoring.
• Experience in site qualification, initiation, monitoring and closeout in accordance with protocol and ICH-GCP.

Responsabilidades

• Primary point of contact for site personnel during the life cycle of a clinical trial, including start-up, activation, conduct and closeout.
• Support Global Project Lead and CTM during project start up to ensure timely site selection and feasibility; assist with regulatory submissions.
• Identify protocol deviations and pharmacovigilance issues affecting data integrity or patient safety.
• Conduct site qualification, initiation, routine monitoring, closeout visits (remote and onsite) and central monitoring per protocol.
• Document monitoring activities via site visit confirmations, letters, visit reports and trial logs.
• Review data listings, vendor dashboards and CTMS to identify trends, errors, or potential data integrity breeches.
• Present CRA function in Bid Defenses, Investigator Meetings and Sponsor meetings.
• Assist with identification of out-of-scope activities and manage site-level milestones and budget.
• Support CTM and Global PM in budget and contract negotiations.

Formação académica

5+ years of CRO experience with at least 3 years of independent drug trial monitoring

Descrição da oferta de emprego

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.

Job Title: Senior CRA (West Coast)

Location: Remote

Function: Clinical Operations

Mandatory Experience: At least 3 years of independent monitoring experience with a CRO

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Primary point of contact for site personnel during life cycle of clinical trial. This includes study start up support, site activation, trial conduct and closeout of a clinical trial.
• Provides support to the Global Project Lead and CTM during project start up to ensure timely site selection and feasibility. Assists with collection of essential documents from the site. May assist with submission of central EC Applications, Local EC applications, RA applications and any other local regulatory applications/Approvals required.
• Ability to identify protocol deviations and pharmacovigilance issues that might affect data accuracy or patient safety.
• Conduct Site qualification, site initiation, routine site monitoring close out visits (remote and onsite), Central monitoring in compliance with study protocol and ICH-GCP.
• Expert documentation of monitoring priorities/activities via site visit confirmation and follow up letters, monitoring visit reports, and any trial associated logs.
• Oversees conduct trials by reviewing study data listings, vendor dashboards, and CTMS issues/actions documentation to identify trends, errors, and any potential breeches that can impact data integrity.
• Ability to present essential function of CRA role in Bid Defenses, Investigator Meetings, and Sponsor Face to Face meetings.
• Assists the Global Project Lead in identification of out-of-scope activities.
• Basic understanding of assigned projects scope, milestones and budget and manages site level activities to ensure project deliverables are met.
• Provides support to the CTM and Global project lead in negotiation of site budgets and contracts.

EDUCATION AND EXPERIENCE REQUIRED:

• 5 Years of experience with a CRO with 3 years independent drug trial monitoring experience

COMPENSATION & BENEFITS:

Siteroproudly offers animpressive compensation package and benefits, including a competitive salary, paid time off, and healthcare and retirement benefits.

EMPLOYMENT TYPE:

Full Time, Permanent

COMMITMENTS:

• Standard Hours 40 hours per week, one hour lunch, Monday – Friday.Additional hours as needed.
• Willing to work in shifts as and when needed.
• Up to 80% travel for Days on Site visits

DISCLAIMER:

Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.