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REGENXBIO

In-House CRA / Clinical Trial Associate

Rockville, MD · On-site

$34.25 - $46.75/hr

As the In-house CRA you will support and coordinate the logistical aspects of clinical trial management, site management, data review and cleaning according to FDA regulations, Good Clinical Practice ...

Because We Care

Full time in house Caregiver

Auburn, GA

$13 - $15/hr

Provide companionship and engage the patient in social and recreational activities. * Help with meal preparation and ensure proper nutrition. * Administer medications and monitor health conditions as ...

Alira Health

The CRA works closely with Lead CRAs, Sr CRAs, in-house CRAs, Associate Director of Clinical Monitoring and Project Managers to ensure protocol compliance, address site questions, and assist with ...

Bhired

In-House Recruiter - 866

New York, NY

$60K/yr

Full Time In-House Recruiter - 866 A growing company healthcare company is looking for a full-time in-house recruiter to join their team. The ideal candidate will have experience in recruiting for ...

Firecrawl

In-House Counsel

San Francisco, CA · On-site

$225K - $265K/yr

In-House Counsel You'll be Firecrawl's first full-time in-house lawyer, owning legal across the business as we scale. Day to day, you'll partner with our revenue teams - redlining customer contracts ...

iCare Health Network

In-House Counsel

Manchester, CT · Hybrid

In-House Counsel iCare Health Network offers a variety of career opportunities for those with a ... The position is full-time (40 hours) hybrid, based in Manchester, with travel throughout ...

iCare Health Network

In-House Counsel

Manchester, CT · On-site

) In-House Counsel iCare Health Network offers a variety of career opportunities for those with a ... The position is full-time (40 hours) hybrid, based in Manchester, with travel throughout ...

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What are some common challenges faced by a Full Time In House CRA, and how can they be managed effectively?

Full Time In House Clinical Research Associates (CRAs) often encounter challenges such as managing multiple clinical trial sites remotely, ensuring timely data collection, and maintaining clear communication with site staff. To handle these effectively, CRAs use robust organizational tools, maintain regular check-ins with site coordinators, and proactively address issues with documentation or protocol compliance. Being adaptable and detail-oriented helps CRAs stay on top of regulatory requirements while supporting quality and consistency across all assigned studies.

What are the key skills and qualifications needed to thrive as a Full Time In House CRA, and why are they important?

To thrive as a Full Time In House Clinical Research Associate (CRA), you need a solid understanding of clinical trial processes, regulatory compliance, and a degree in life sciences or a related field. Familiarity with electronic data capture (EDC) systems, CTMS, and Good Clinical Practice (GCP) certification is typically required. Strong organizational skills, attention to detail, and effective communication are crucial soft skills for managing study documentation and collaborating with study teams. These competencies ensure the integrity of clinical research data, compliance with regulations, and efficient coordination of clinical trials.

What is the difference between Full Time In House Cra vs Contract Cra?

AspectFull Time In House CraContract Cra
Employment TypePermanent, full-timeTemporary, project-based
Work EnvironmentIn-office or hybrid, within a company's facilitiesOften remote or on-site at various locations
CredentialsTypically requires a relevant degree and experienceSimilar credentials, but may vary based on project needs
Industry UsageCommon in pharmaceutical and biotech companiesUsed across clinical research organizations and sponsors

Full Time In House Cras are permanent employees working within a company's research team, offering stability and ongoing involvement. Contract Cras are hired for specific projects, providing flexibility but less job security. Both roles require similar credentials and are prevalent in the clinical research industry, but differ mainly in employment status and work setup.

What does a Full Time In House CRA do?

A Full Time In House Clinical Research Associate (CRA) is responsible for supporting the management and monitoring of clinical trials from an office-based setting rather than traveling to trial sites. Their duties often include reviewing study documentation, ensuring compliance with protocols and regulatory requirements, communicating with site staff, and tracking study progress. In-house CRAs play a crucial role in maintaining data integrity, supporting site management, and assisting field-based CRAs to ensure successful clinical trial execution.
What cities are hiring for Full Time In House Cra jobs? Cities with the most Full Time In House Cra job openings:
What are the most commonly searched types of In House Cra jobs? The most popular types of In House Cra jobs are:
What states have the most Full Time In House Cra jobs? States with the most job openings for Full Time In House Cra jobs include:
Full Time In House Cra jobs near you
In-House CRA / Clinical Trial Associate

In-House CRA / Clinical Trial Associate

REGENXBIO

Rockville, MD • On-site

$34.25 - $46.75/hr

Full-time

Retirement

Posted 5 days ago

Job description

The opportunity:
As the In-house CRA you will support and coordinate the logistical aspects of clinical trial management, site management, data review and cleaning according to FDA regulations, Good Clinical Practice (GCP) and relevant SOPs and acts as a pivotal point of contact for the clinical trial team. Under general supervision, you will assist with the coordination of activities associated with the start-up, conduct, and close-out of clinical trials and other duties as assigned. Although prior CRA experience is not essential, a working knowledge of the clinical trial process and associated regulations, responsibilities, and roles are required.
What you'll be doing:
  • Assists in the development and editing of study-related materials (e.g. consent forms, study binders, site study aids)
  • Assists with preparation of training workshops, Investigator/Advisory Board meeting materials
  • Assists with all phases of clinical trial activities (e.g. start-up, conduct, and close-out)
  • Develops study tracking tools (e.g. site lists, enrollment tracking, vendor spreadsheets)
  • Maintains tracking spreadsheets/databases and provides routine reports/dashboards to study team members
  • Requests PO independently, may review invoices with oversight from Clinical Project Manager (CPM)
  • Tracks essential documents and maintains/reviews the eTMF under the guidance of CPM.
  • Assists with management of investigational product and study supplies by ensuring the accuracy of shipments of study-related materials and collection of regulatory documents required for IP release
  • May attend co-monitoring visits or other site visits based on experience and training provided by and under guidance of CPM or designee
  • Assists the CPM with the review of clinical database and management of flow of data, including but not limited to facilitating resolution of queries
  • Assists with collection, review and filing of regulatory and other essential documents from clinical personnel (e.g. site trip reports) and sites (e.g. FDA 1572 reports)
  • Assists with filing and management of the Electronic Trial Master File (eTMF)
  • Distributes meeting's agenda, prepare and distributes final meeting minutes including documentation of action items
  • May assume a specialized administrative role (e.g. SOP Administrator)
  • Travel up to 5% of the time is required
  • It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.

What we're looking for:
We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:
  • A Bachelor's degree (BA or BS) with an emphasis on scientific discipline or related healthcare field preferred, however, the combination of experience working in clinical research field and training will be taken under consideration.
  • 1-2 years applicable experience in a pharmaceutical, biotechnology, CRO and /or healthcare setting required
  • Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations, GCP/ICH R2
  • Demonstrate core understanding of medical terminology or clinical trial activities
  • Must have working knowledge and understanding of clinical protocols, and all other associated study related documents
  • Advanced knowledge of Word, Excel and Power Point and Outlook
  • Knowledge of the principles and practices of computer applications in database management
  • Must have a high degree of customer focus toward internal and external stakeholders
  • Must display strong analytical and problem-solving skills
  • Strong interpersonal and relationship management with the cross-functional team and external vendors skills
  • Clear and concise verbal and written communication skills
  • Attention to detail and organizational skills required
  • Ability to establish priorities, excellent sense of urgency to manage multiple tasks and deadlines

Why should you apply?
By joining REGENXBIO, you will have the opportunity to be a part of a growing company, with an incredible team, who is passionate about developing novel AAV gene therapies for patients in need.
We offer a comprehensive and competitive benefit & compensation package which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more!
In addition, professional development is important to us. By joining our team, you'll have the opportunity to be exposed to challenging projects and have access to development resources to help you grow personally and professionally.
Qualifications
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Education
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Preferred
Bachelor of Science (B.S.) or better.
Skills & Requirements Qualifications

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