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In-house Clinical Research Associate
In-house Clinical Research AssociateRho • Durham, North Carolina, US
In-house Clinical Research Associate

In-house Clinical Research Associate

Rho • Durham, North Carolina, US
30+ days ago
Job type
  • Full-time
Job description

Overview

Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.

We are currently hiring an In-House Clinical Research Associate to join our team! As an In-House CRA here at Rho, you’ll have the opportunity to work with the Project Manager, traveling CRAs and Lead CRA on a clinical trial to ensure that monitoring activities are properly supported and that critical documents are being tracked, collected, and reviewed. You’ll manage data entered into the CTMS (clinical trials management system) and other project tracking tools. You’ll also assist CRAs on query resolution and data reviews to ensure that studies operate in compliance with study protocols, Rho SOPs, ICH/GCP guidelines, and federal regulations. You may also have the opportunity to mentor other team members.

Our Clinical Team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group!

Responsibilities

  • Collect, track and review investigational site records relating to subject screening and enrollment
  • Assist in the development of study plans and status reports
  • Collect, track, and review all site regulatory documents
  • Assist with development and review of Informed Consent Forms
  • Interact with sites, clients, vendors and internal study team members
  • Maintain the clinical trials management system (CTMS) and other project tracking tools
  • Track study supplies and coordinate shipments of supplies to sites as needed
  • Manage the study Trial Master File (TMF) and ensure periodic TMF audits
  • Coordinate work with CRAs monitoring on-site
  • Perform on site co-monitoring and remote monitoring activities
  • Perform regular reviews of data entered by investigational site staff according to data review/monitoring guidelines

Qualifications

  • Bachelors Degree in a life science, nursing or pharmacy field, along with at least 1 year of direct work experience managing essential documents withing the CRO, pharma or biotech industry.
  • Good knowledge of clinical research process and an understanding of Regulatory and Central/Local ethic submission processes for assigned countries; working knowledge of current ICH GCP guidelines and applicable regulations
  • Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho’s.
  • Committed to Quality: Every job at Rho requires an attention to detail, a deep understanding of our high-quality scientific standards, and an ability to care about every outcome.
  • High-Character: Contribute to our collaborative culture with honesty and integrity. At Rho, we value a strong team spirit highlighted by loyalty, accountability, and mutual trust. We work smart together, we work hard together, and we laugh together. We take responsibility for our actions, forgive honest mistakes and respect one another.
  • Critical Thinker: Rho values thinking. Draw on your native ingenuity, sharpened and enhanced by our intellect, training, and experience. We evaluate situations and opportunities objectively and incisively; we then craft novel, practical solutions.
  • Agile and Adaptable: Rho values the ability to change quickly. We eagerly anticipate, respond to, and take advantage of changes in our environment. We embrace risk but manage it by planning, accepting, and learning from both failures and successes. The opportunity to adapt and evolve energizes us.

A few more things to know about us:

Benefits: Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k). All employees are eligible for paid time off, holidays, parental leave and bereavement leave.

Diversity and Inclusion: As a global, full-service CRO driven by our collective experiences, we view each of our backgrounds as a vital component in our formula for success and we strive towards building a more equitable, inclusive, and diverse environment for our employees every day. By valuing and tapping into each employee’s unique and different personal experiences, we are able to uplift employee dignity and belonging, foster more strategic creativity, and more quickly arrive at breakthrough solutions that help us heal the world.

Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.

As required by pay transparency laws in some states, Rho provides the range of starting compensation (annual salary or hourly rate) it reasonably expects to pay for a given role. Actual compensation is influenced by a wide array of factors including but not limited to role responsibilities and location as well as candidate skill set and level of experience. The range of starting pay for this role is $55,000-$75,000 per year.

EOE. Veterans/Disabled

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In-house Clinical Research Associate • Durham, North Carolina, US

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