The Role
The Clinical Research Associate will manage study maintenance and closeout activities, liaise with study teams and external partners, and monitor clinical data and safety metrics.
Summary Generated by Built In
This is a remote position.
We are seeking experienced Clinical Research Associates (CRAs) to provide surge capacity support for ongoing clinical research projects. This role focuses on study maintenance and closeout activities, ensuring efficient project execution. The CRA will serve as a primary point of contact for study teams and external partners, supporting essential clinical operations without direct involvement in study startup activities.
Key Responsibilities:
Oversee study-level project management tasks, including study maintenance, data lock, closeout, document review, and budget monitoring.
Act as the primary liaison between internal study teams and external third-party organizations (TPOs).
Track and monitor safety, biomarker, pharmacokinetic (PK), anti-drug antibody (ADA) samples, imaging data, and connected device data.
Manage and track clinical queries to ensure timely resolution.
Collaborate with internal teams to align clinical research processes and operational strategies.
Coordinate with business partners and TPOs to facilitate data delivery and ensure compliance with study requirements.
Minimum Qualifications:
Bachelor’s degree in a relevant field.
6+ years of experience in clinical research or a related industry.
Experience as a Clinical Research Associate, Clinical Research Coordinator, or Clinical Research Assistant.
3+ years of experience in project management or a related role.
Prior experience in pharmaceutical, diagnostics, or CRO environments.
Strong organizational skills with attention to detail.
Ability to effectively communicate with diverse stakeholders.
Proficiency in Microsoft Excel for data tracking and reporting.
Experience with clinical trial management tools such as Medidata RAVE, Veeva Vault, Oracle InForm, or similar platforms.
Familiarity with electronic Trial Master File (eTMF) systems, query management tools, and safety reporting databases.
Working knowledge of GCP (Good Clinical Practice) guidelines and regulatory compliance requirements.
In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well-being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work-life balance while providing the necessary support for professional and personal growth.
Key Responsibilities:
Oversee study-level project management tasks, including study maintenance, data lock, closeout, document review, and budget monitoring.
Act as the primary liaison between internal study teams and external third-party organizations (TPOs).
Track and monitor safety, biomarker, pharmacokinetic (PK), anti-drug antibody (ADA) samples, imaging data, and connected device data.
Manage and track clinical queries to ensure timely resolution.
Collaborate with internal teams to align clinical research processes and operational strategies.
Coordinate with business partners and TPOs to facilitate data delivery and ensure compliance with study requirements.
Minimum Qualifications:
Bachelor’s degree in a relevant field.
6+ years of experience in clinical research or a related industry.
Experience as a Clinical Research Associate, Clinical Research Coordinator, or Clinical Research Assistant.
3+ years of experience in project management or a related role.
Prior experience in pharmaceutical, diagnostics, or CRO environments.
Strong organizational skills with attention to detail.
Ability to effectively communicate with diverse stakeholders.
Proficiency in Microsoft Excel for data tracking and reporting.
Experience with clinical trial management tools such as Medidata RAVE, Veeva Vault, Oracle InForm, or similar platforms.
Familiarity with electronic Trial Master File (eTMF) systems, query management tools, and safety reporting databases.
Working knowledge of GCP (Good Clinical Practice) guidelines and regulatory compliance requirements.
In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well-being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work-life balance while providing the necessary support for professional and personal growth.
Be part of our network of Subject Matter Experts.
E-Verify Participation:
Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify.
Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify.
Skills Required
- Bachelor's degree in a relevant field
- 6+ years of experience in clinical research or a related industry
- Experience as a Clinical Research Associate, Clinical Research Coordinator, or Clinical Research Assistant
- 3+ years of experience in project management or a related role
- Prior experience in pharmaceutical, diagnostics, or CRO environments
- Strong organizational skills with attention to detail
- Ability to effectively communicate with diverse stakeholders
- Proficiency in Microsoft Excel for data tracking and reporting
- Experience with clinical trial management tools
- Familiarity with electronic Trial Master File (eTMF) systems
- Working knowledge of GCP guidelines and regulatory compliance requirements
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The Company
What We Do
Pharmavise is a regulatory compliance consulting firm specializing in the life sciences industry, providing solutions throughout the product lifecycle for pharmaceutical, medical device, and biotechnology clients.
