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Study Start-Up Associate

🔥 16 hours ago

🇺🇸 United States – Remote

💵 $55k - $65k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

Where this job comes from

Posted on Rho's careers page, not through a job board

First seen by Remote Rocketship 16 hours ago

Still open on Rho's site. Checked 14 hours ago.

Logo of Rho

Rho

501 - 1000 employees

Founded 1984

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Rho is a financial technology company that provides integrated banking solutions for businesses, combining modern banking with cash management and expense tracking. Their platform focuses on streamlining financial operations and offering a user-friendly interface for better control of company finances.

📋 Description

• Participate in the study start-up process through site activation • Provide timely and professional customer service to internal and external parties • Collaborate with Feasibility, CTL, SSUL, Rho Legal, Sponsors, site staff, and multidisciplinary project teams • Obtain site lists and ensure fully executed CDAs are established • Contribute to trial feasibility by distributing questionnaires and following up with site personnel • Maintain SSU trackers, databases, shared documentation, and relevant metrics • File site-level feasibility documentation in the TMF • Support regulatory and IRB/IEC document collection, preparation, execution, submissions, and approvals • Provide administrative support including formatting, quality control checks, document versioning, and uploading documents to regulatory and IRB/IEC platforms • Coordinate site-level regulatory and IRB/IEC submissions and approvals • Create, distribute, collect, review, and approve Site Essential Document packages under SSU Lead guidance • Support adaptation, review, quality control, negotiation, and approval of site-level Informed Consent Forms • Track, maintain, and file SED documentation in SSU databases, trackers, and TMF • Liaise with Rho Legal and sites to facilitate negotiation and execution of site budgets and contracts • Track budgets and contracts, update databases, file documents, and collect site-level information • Maintain systems to track site-level progress and support SSU progress metrics • Partner with the SSU Lead to determine and execute site-by-site handoffs to Clinical Operations

🎯 Requirements

• Bachelor’s Degree • At least 1 year of experience within the clinical research setting, preferably within a CRO • Good knowledge of general clinical research processes and medical terminology • Basic understanding of Regulatory and IRB/IEC submission processes for assigned countries • Working knowledge of current ICH GCP guidelines and applicable regulations • Good written and verbal communication skills • Takes initiative to complete project responsibilities, seeking guidance as needed • Good organizational and time management skills, able to meet deadlines • Strong attention to detail • Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities • Ability to manage multiple competing priorities within various clinical trials and work as a strong team player

🏖️ Benefits

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

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