Clinical Research Associate (CRA)

Pharmavise Corporation; United States; Remote; USD 95,000 - 130,000; Full time

Benefits offered by this job

Paid holidays

PTO

Medical insurance

Healthy work-life balance

Job summary

Pharmavise Corporation seeks experienced Clinical Research Associates for remote surge capacity supporting ongoing trials. You will manage maintenance, data lock, closeout, and act as liaison between study teams and external partners, ensuring efficient clinical operations without startup duties.

The ideal candidate has 6+ years in clinical research, 3+ years in project management, and proficiency with Medidata RAVE and Veeva Vault, plus strong communication and organizational skills.

Qualifications

• Bachelor’s degree in a relevant field.
• 6+ years in clinical research or related field.
• Experience as a CRA/CRS/CRA assistant.
• 3+ years in project management or related role.
• Experience in pharma/diagnostics/CRO environments.
• Strong organizational skills and attention to detail.
• Proficient in Microsoft Excel for data tracking and reporting.
• Experience with clinical trial management tools (Medidata RAVE, Veeva Vault, Oracle InForm).
• Familiarity with eTMF, query management tools, and safety reporting databases.
• Working knowledge of GCP guidelines and regulatory requirements.

Responsibilities

• Oversee study-level project management tasks including maintenance, data lock, closeout, document review, and budget monitoring.
• Act as the primary liaison between internal study teams and external third-party organizations.
• Track and monitor safety, biomarker, PK, 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 study compliance.

Skills

Project management

Communication

Attention to detail

Cross-functional collaboration

GCP knowledge

Education

Bachelor’s degree in a relevant field

Tools

Medidata RAVE

Veeva Vault

Oracle InForm

eTMF systems

Job description

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, OracleInForm, 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.