Sr. Clinical Trial Associate
New Brunswick, NJFull-time
Behavioral Health Market Context
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Benefits
Health InsurancePaid Time Off
Job Description
nt of the CTA Manager.
• Work with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.
• Perform departmental tasks.
• Perform developmental tasks with oversight of CTA Manager.
ACCOUNTABILITIES:
For assigned complex, accelerated, and business essential studies, provide support to focus on study startup and site initiation activities, including:
• Approval of study documentation, including essential document packets, study plans, informed consent forms, etc.
• Support oversight of risk-based monitoring.
• Attend important team meetings.
• Support regulatory inspection readiness (e.g. preparation of materials and participation during regulatory inspections.)
• Support additional ad-hoc activities, as agreed with CTA Manager.
• Work with internal departments (Legal, Insurance, R&D functions), CROs, and vendors.
• Escalate clinical trial insurance issues.
• Support Health Care Provider Engagement for facilitating contracts and meetings.
• Support vendor contract administration.
Requirements
• Bachelor's degree or equivalent international degree.
• 5 or more years' experience in pharmaceutical industry, clinical research organization, or related role.
• Experience in Phase 2 and 3 studies and global/international studies is advantageous.
• Experience working across multiple therapeutic areas is advantageous.
• Knowledge in global regulatory and compliance requirements for clinical research.
• Excellence in task management and collaboration.
• Requires availability for 5-10% domestic and international travel, including overnight and international travel on an as-needed basis.
Benefits
• 401(k) with company match and Annual Retirement Contribution Plan
• Tuition reimbursement Company match of charitable contributions
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs
• Work with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.
• Perform departmental tasks.
• Perform developmental tasks with oversight of CTA Manager.
ACCOUNTABILITIES:
For assigned complex, accelerated, and business essential studies, provide support to focus on study startup and site initiation activities, including:
• Approval of study documentation, including essential document packets, study plans, informed consent forms, etc.
• Support oversight of risk-based monitoring.
• Attend important team meetings.
• Support regulatory inspection readiness (e.g. preparation of materials and participation during regulatory inspections.)
• Support additional ad-hoc activities, as agreed with CTA Manager.
• Work with internal departments (Legal, Insurance, R&D functions), CROs, and vendors.
• Escalate clinical trial insurance issues.
• Support Health Care Provider Engagement for facilitating contracts and meetings.
• Support vendor contract administration.
Requirements
• Bachelor's degree or equivalent international degree.
• 5 or more years' experience in pharmaceutical industry, clinical research organization, or related role.
• Experience in Phase 2 and 3 studies and global/international studies is advantageous.
• Experience working across multiple therapeutic areas is advantageous.
• Knowledge in global regulatory and compliance requirements for clinical research.
• Excellence in task management and collaboration.
• Requires availability for 5-10% domestic and international travel, including overnight and international travel on an as-needed basis.
Benefits
• 401(k) with company match and Annual Retirement Contribution Plan
• Tuition reimbursement Company match of charitable contributions
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs
Qualifications
- •Bachelor's degree or equivalent international degree
- •5 or more years' experience in pharmaceutical industry, clinical research organization, or related role
- •Experience in Phase 2 and 3 studies and global/international studies is advantageous
- •Experience working across multiple therapeutic areas is advantageous
- •Knowledge in global regulatory and compliance requirements for clinical research
- •Excellence in task management and collaboration
- •Requires availability for 5-10% domestic and international travel, including overnight and international travel on an as-needed basis
Benefits
- •401(k) with company match and Annual Retirement Contribution Plan
- •Tuition reimbursement Company match of charitable contributions
- •Health & Wellness programs including onsite flu shots and health screenings
- •Generous time off for vacation and the option to purchase additional vacation days
- •Community Outreach Programs
Responsibilities
- •The remote-based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan
- •Provide support for essential daily clinical study activities, including regulatory inspection readiness, following established protocols under the general management of the CTA Manager
- •Work with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model
- •Perform departmental tasks
- •Perform developmental tasks with oversight of CTA Manager
- •For assigned complex, accelerated, and business essential studies, provide support to focus on study startup and site initiation activities, including:
- •Approval of study documentation, including essential document packets, study plans, informed consent forms, etc
- •Support oversight of risk-based monitoring
- •Attend important team meetings
- •Support regulatory inspection readiness (e.g. preparation of materials and participation during regulatory inspections.)
- •Support additional ad-hoc activities, as agreed with CTA Manager
- •Work with internal departments (Legal, Insurance, R&D functions), CROs, and vendors
- •Escalate clinical trial insurance issues
- •Support Health Care Provider Engagement for facilitating contracts and meetings
- •Support vendor contract administration
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