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.
Critical Thinker: Rho values thinking. Draw on your native ingenuity, sharpened and enhanced by our intellect, training, and experience.
Agile and Adaptable: Rho values the ability to change quickly. We eagerly anticipate, respond to, and take advantage of changes in our environment.

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trials managementdata reviewmonitoring guidelinesregulatory document managementInformed Consent Forms developmentTrial Master File managementco-monitoringremote monitoringstudy plan developmentstatus report development

Soft Skills

strong communicatorattention to detailcommitment to qualitycollaborative culturecritical thinkeragileadaptablehonestyintegrityteam spirit