Study Start-Up Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Engage in the study initiation process through site activation.

• Deliver prompt and professional customer service to both internal and external stakeholders.

• Collaborate with Feasibility, CTL, SSUL, Rho Legal, Sponsors, site personnel, and multidisciplinary project teams.

• Acquire site lists and ensure that fully executed CDAs are in place.

• Contribute to trial feasibility by distributing questionnaires and following up with site staff.

• Maintain SSU trackers, databases, shared documentation, and relevant metrics.

• Organize site-level feasibility documentation within the TMF.

• Assist in the collection, preparation, execution, submission, and approval of regulatory and IRB/IEC documents.

• Provide administrative support, which includes 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 the guidance of the SSU Lead.

• Support the adaptation, review, quality control, negotiation, and approval of site-level Informed Consent Forms.

• Track, maintain, and file SED documentation within SSU databases, trackers, and the TMF.

• Liaise with Rho Legal and sites to facilitate the negotiation and execution of site budgets and contracts.

• Monitor budgets and contracts, update databases, file documents, and gather site-level information.

• Maintain systems for tracking site-level progress and support SSU progress metrics.

• Collaborate with the SSU Lead to determine and carry out site-by-site transitions to Clinical Operations.

⛳️ Requirements

• Bachelor’s Degree.

• Minimum of 1 year of experience in a clinical research environment, preferably within a CRO.

• Strong understanding of general clinical research processes and medical terminology.

• Basic knowledge of Regulatory and IRB/IEC submission processes for designated countries.

• Familiarity with current ICH GCP guidelines and applicable regulations.

• Effective written and verbal communication skills.

• Proactive in completing project responsibilities while seeking guidance when necessary.

• Excellent organizational and time management abilities, with a capacity to meet deadlines.

• High level of attention to detail.

• Positive demeanor with the ability to engage with all staff levels to coordinate and execute study activities.

• Capability to manage multiple competing priorities across various clinical trials and to function effectively as part of a team.

🏝️ 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.