Job Description

Overview:

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at and follow us on LinkedIn:  

Our Fortune 500 Pharmaceutical client has an exciting opportunity for a Clinical Research Associate (CRA). 

Job Summary: 

The Clinical Laboratory Services (CLS) team of our client currently has a business need for surge capacity coverage for delivery based Clinical Research Associate (CRA) roles.  This surge capacity model would utilize US-based contractor CRAs to focus on specific tasks/deliverables. The CRAs would not be trained on study startup activities but would be the single point of contact representing CLS to study teams and TPOs throughout study maintenance and closeout. 

The CRA will be based in Indiana (working at the client’s headquarters with the option of up to 50% remote work after training is complete).  

Responsibilities and Job Requirements:  

• Study level project management – including maintenance, data lock and closeout, document flow (review/approvals), budget management 
• Single point of contact for study teams and CLS TPOs 
• Tracking of safety, biomarker, PK and ADA samples as well as imaging and connected devices 
• Query tracking and management 
• Internal & External Engagement - Collaborate with internal business partners regarding CLS processes and business operations 
• Collaborate with business partners and TPOs to ensure data delivery 

Requirements:  

• Bachelor’s degree 
• 6+ years of experience in the Clinical Industry 
• Clinical Research Assistant/Coordinator experience 
• Local to Indiana 
• 3+ years of Project Management Associate (or similar) experience 
• Prior experience in pharma, diagnostics or CRO environment 
• Experience in clinical research or a closely related field 
• Demonstrated ability to communicate clearly 
• Demonstrated attention to detail and organization 
• Skilled in Microsoft Excel for report combining and tracking 

Other Details:  

• Schedule: Full Time 
• Contract Length: 12 months with renewal 
• Set-up: Onsite in Indianapolis, IN 

EEO Employer:  

Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Pharmavise Consulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contact info@pharmavise.com . 

Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you join Pharmavise, you become part of a team that values Excellence Through Quality. 

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. 

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