Clinical Trial Associate
Behavioral Health Market Context
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Job Description
Assisting with project start-up, including development of budgets, contracts, financial disclosure statements, and grant payments.
• Collaborating with Program Leaders to develop study-related materials (e.g., informed consent forms, Advertising Materials, sections of study plans, etc.) as required.
• Assist in the oversight, processing, and management of all clinical project-related documents including Investigator Site Regulatory Documents, Case Report Forms (CRF), and Monitoring Reports.
• Reviewing the work of CROs and other vendors (Field Monitors, Central Labs, Clinical Supply Distributors, etc.) assigned to clinical studies to provide feedback to study manager.
• Communicating seamlessly and effectively with internal and external study personnel. Developing and maintaining good working relationships with Investigators and study staff.
• Assist in the routing of Communication Logs, Training logs, and Protocol Deviation Assessments and other documents as required for the study.
• Copy, distribute, and file Serious Adverse Event communications as required.
• Preparation and distribution of project status reports, newsletters, and study event memorandums.
• Provide support for maintaining both electronic and paper document-tracking systems for all documents associated with the start-up and execution of clinical studies.
• Review and verify investigator site visit grant calculations, prepare PO requisitions, and forward invoices, site payment letters, and expense reports.
• Review Investigator and Project files throughout a clinical trial and follow up with CSM on any discrepancy or missing documents.
• Assist in the maintenance of Standard Operating Procedures (SOPs) and Work Instructions.
• Assist in the preparation of an Investigator Meeting.
• Updates internal and external systems in a timely manner (CTMS, clinicaltrials.gov).
• Assists with the maintenance of the Trial Master File.
• Developing and maintaining study trackers and providing metrics as needed.
• Participating in user acceptance testing (UAT) of clinical systems, including EDC and interactive response technology (IRT).
Education and Experience Requirements:
• Bachelor’s degree in related discipline and a minimum of 4 years of clinical trials or Sponsor experience
• Clinical operations experience in Phase 2 to Phase 3 clinical trials including global clinical trials.
• Working knowledge of ICH GCP regulations.
• Previous experience in any group of Pulmonary Hypertension or inhalation research strongly preferred
• Strong initiative and desire to work in a fast-paced, team-oriented, and dynamic environment.
• Excellent written and verbal communication skills and proven ability to multitask.
• Efficient time management and strong organizational skills. Attention to detail and quality are critical to success in this role.
• Ability to travel if required.
• Collaborating with Program Leaders to develop study-related materials (e.g., informed consent forms, Advertising Materials, sections of study plans, etc.) as required.
• Assist in the oversight, processing, and management of all clinical project-related documents including Investigator Site Regulatory Documents, Case Report Forms (CRF), and Monitoring Reports.
• Reviewing the work of CROs and other vendors (Field Monitors, Central Labs, Clinical Supply Distributors, etc.) assigned to clinical studies to provide feedback to study manager.
• Communicating seamlessly and effectively with internal and external study personnel. Developing and maintaining good working relationships with Investigators and study staff.
• Assist in the routing of Communication Logs, Training logs, and Protocol Deviation Assessments and other documents as required for the study.
• Copy, distribute, and file Serious Adverse Event communications as required.
• Preparation and distribution of project status reports, newsletters, and study event memorandums.
• Provide support for maintaining both electronic and paper document-tracking systems for all documents associated with the start-up and execution of clinical studies.
• Review and verify investigator site visit grant calculations, prepare PO requisitions, and forward invoices, site payment letters, and expense reports.
• Review Investigator and Project files throughout a clinical trial and follow up with CSM on any discrepancy or missing documents.
• Assist in the maintenance of Standard Operating Procedures (SOPs) and Work Instructions.
• Assist in the preparation of an Investigator Meeting.
• Updates internal and external systems in a timely manner (CTMS, clinicaltrials.gov).
• Assists with the maintenance of the Trial Master File.
• Developing and maintaining study trackers and providing metrics as needed.
• Participating in user acceptance testing (UAT) of clinical systems, including EDC and interactive response technology (IRT).
Education and Experience Requirements:
• Bachelor’s degree in related discipline and a minimum of 4 years of clinical trials or Sponsor experience
• Clinical operations experience in Phase 2 to Phase 3 clinical trials including global clinical trials.
• Working knowledge of ICH GCP regulations.
• Previous experience in any group of Pulmonary Hypertension or inhalation research strongly preferred
• Strong initiative and desire to work in a fast-paced, team-oriented, and dynamic environment.
• Excellent written and verbal communication skills and proven ability to multitask.
• Efficient time management and strong organizational skills. Attention to detail and quality are critical to success in this role.
• Ability to travel if required.
Qualifications
- •Bachelor’s degree in related discipline and a minimum of 4 years of clinical trials or Sponsor experience
- •Clinical operations experience in Phase 2 to Phase 3 clinical trials including global clinical trials
- •Working knowledge of ICH GCP regulations
- •Strong initiative and desire to work in a fast-paced, team-oriented, and dynamic environment
- •Excellent written and verbal communication skills and proven ability to multitask
- •Efficient time management and strong organizational skills
- •Attention to detail and quality are critical to success in this role
- •Ability to travel if required
Benefits
Responsibilities
- •The Clinical Trial Associate is a member of the Clinical Operations team
- •The Clinical Operations team is responsible for executing, managing, and conducting studies associated with the company’s clinical development plans
- •This position requires coordination with all members of the Clinical Operations team as well as other internal and external team members
- •Assisting with project start-up, including development of budgets, contracts, financial disclosure statements, and grant payments
- •Collaborating with Program Leaders to develop study-related materials (e.g., informed consent forms, Advertising Materials, sections of study plans, etc.)
- •Assist in the oversight, processing, and management of all clinical project-related documents including Investigator Site Regulatory Documents, Case Report Forms (CRF), and Monitoring Reports
- •Reviewing the work of CROs and other vendors (Field Monitors, Central Labs, Clinical Supply Distributors, etc.) assigned to clinical studies to provide feedback to study manager
- •Communicating seamlessly and effectively with internal and external study personnel
- •Developing and maintaining good working relationships with Investigators and study staff
- •Assist in the routing of Communication Logs, Training logs, and Protocol Deviation Assessments and other documents as required for the study
- •Copy, distribute, and file Serious Adverse Event communications as required
- •Preparation and distribution of project status reports, newsletters, and study event memorandums
- •Provide support for maintaining both electronic and paper document-tracking systems for all documents associated with the start-up and execution of clinical studies
- •Review and verify investigator site visit grant calculations, prepare PO requisitions, and forward invoices, site payment letters, and expense reports
- •Review Investigator and Project files throughout a clinical trial and follow up with CSM on any discrepancy or missing documents
- •Assist in the maintenance of Standard Operating Procedures (SOPs) and Work Instructions
- •Assist in the preparation of an Investigator Meeting
- •Updates internal and external systems in a timely manner (CTMS, clinicaltrials.gov)
- •Assists with the maintenance of the Trial Master File
- •Developing and maintaining study trackers and providing metrics as needed
- •Participating in user acceptance testing (UAT) of clinical systems, including EDC and interactive response technology (IRT)
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