In-House Clinical Research Associate
About The Position
Rho is hiring an In-House Clinical Research Associate to support clinical trial monitoring activities and help ensure critical study documents are tracked, collected, and reviewed. The role works with the Project Manager, traveling CRAs, and Lead CRA, and manages information in the clinical trials management system (CTMS) and other project tracking tools. The position supports query resolution and data reviews to help ensure studies comply with study protocols, Rho SOPs, ICH/GCP guidelines, and federal regulations. It offers an opportunity to gain experience toward a future traveling CRA role and may include mentoring other team members.
Requirements
- Bachelor’s degree in a life science, nursing, or pharmacy field.
- At least 1 year of direct experience managing essential documents within the CRO, pharmaceutical, or biotech industry.
- Good knowledge of the clinical research process.
- Understanding of regulatory and central/local ethics submission processes for assigned countries.
- Working knowledge of current ICH GCP guidelines and applicable regulations.
- Desire or career goal of growing into a traveling CRA role.
- Strong written, verbal, and presentation communication skills.
- Attention to detail and commitment to high-quality scientific standards.
- Honesty, integrity, accountability, and ability to contribute to a collaborative team culture.
- Critical thinking, ingenuity, and ability to develop practical solutions.
- Agility and adaptability, including the ability to respond to change.
Responsibilities
- Collect, track, and review investigational site records relating to subject screening and enrollment.
- Assist in developing study plans and status reports.
- Collect, track, and review site regulatory documents.
- Assist with the 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 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.
- Regularly review data entered by investigational site staff according to data review and monitoring guidelines.
- Assist CRAs with query resolution and data reviews.
Benefits
- Medical insurance
- Vision insurance
- Dental insurance
- Health savings account (HSA)
- Flexible spending account (FSA)
- Employee assistance program (EAP)
- Life and disability insurance
- 401(k)
- Paid time off
- Paid holidays
- Parental leave
- Bereavement leave
- Work-life balance flexibility
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
