In-House Clinical Research Associate

Rho

United States

Presencial

USD 55.000 - 65.000

Jornada completa

hace 16 horas
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Ventajas ofrecidas por este puesto de trabajo

Medical insurance
Vision insurance
Dental insurance
HSA
FSA
401(k)
Paid time off
Holidays
Parental leave
Bereavement leave
Work-life balance

Descripción de la vacante

Rho is hiring an in-house Clinical Research Associate in the United States to support monitoring activities, ensure regulatory compliance, and manage data in CTMS. You will collaborate with the Project Manager, traveling CRAs, and Lead CRA to ensure study documents are tracked and reviewed per ICH/GCP standards.

The role offers growth into a traveling CRA path with opportunities to mentor others, and requires strong communication, attention to detail, and a commitment to quality within a CRO

Formación

  • Bachelor degree in life science, nursing or pharmacy and at least 1 year of direct work experience managing essential documents within CRO/pharma/biotech.
  • Good knowledge of clinical research process and understanding of regulatory and ethics submission processes; working knowledge of ICH GCP.
  • Desire/career goal of growing into a traveling CRA role.
  • Strong written, verbal and presentation skills to communicate outcomes and value of work.
  • Commitment to quality and high scientific standards.

Responsabilidades

  • Collect, track and review investigational site records relating to screening and enrollment.
  • Assist in 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 CTMS and other project tracking tools.
  • Track study supplies and coordinate shipments to sites.
  • Manage the TMF and ensure periodic TMF audits.
  • Coordinate work with CRAs monitoring on-site.
  • Perform on-site co-monitoring and remote monitoring activities.
  • Review data entered by investigational site staff according to data review guidelines.

Conocimientos

Strong communication
Critical thinking
Agile & adaptable
Team collaboration
Attention to detail

Educación

Bachelor's degree in Life Science / Nursing / Pharmacy

Herramientas

CTMS
Regulatory databases

Descripción del empleo

Join us in redefining what it means to work for a CRO.

When you work at Rho, it's more than just a job—you become part of the Rho Factor. We're a proud bunch of science nerds who love tackling big challenges together. We're not your typical CRO, and we're not trying to be. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do.

Whether you're a data wizard, analytical genius, project mastermind, or any other role, you'll fit right into the equation of the Rho Factor. Expect plenty of geeky jokes, eccentric personalities, spontaneous brainstorms, and a supportive community where people genuinely care about their work—and each other.

You'll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career.

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 gain the necessary experience to grow into a traveling Clinical Research Associate (CRA) and 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 Operations 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!

What You'll Be Doing
  • 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
Requirements
  • Bachelors Degree in a life science, nursing or pharmacy field, along with at least 1 year of direct work experience managing essential documents within 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
  • Desire / Career Goal of growing into a traveling CRA role
  • 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.
Benefits

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.

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-$65,000 per year.

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