Study Start-Up Associate

We are currently hiring a Study Start-up Associate or Senior Start Up Associate to join our team! As an SSUA here at Rho, you will have the opportunity to coordinate study start-up activities including investigator assessment and identification, pre-study development, site qualification, and site activation. You will work in a pivotal role requiring collaboration with internal and external stakeholders, working closely with the clinical study team under the direction of the SSU Lead, other functional areas, study vendors and sponsors to support the study start-up process.

Responsibilities

• Under the direction of the SSU Lead and Feasibility Manager, participate in the study start up process through site activation on a global scale.
• Ensure relevant systems are maintained and up-to-date to analyze study start up progress metrics against targets/timelines (at a project/country/site level).
• Contribute to the Pre-Feasibility and Post-Feasibility Report, specifically organizing questionnaires and feedback.
• Participate with the Feasibility Manager, Rho Legal, Sponsor, and relevant Site Staff to fully execute necessary CDAs.
• Coordinate and develop the necessary site budget and contract, communicating with the SSU Lead to gain approval between Sponsor and Rho Legal, and file completed documents.
• Coordinate the collection and review of the Site Essential Document (SED) packet, working directly with Site Staff; track the completion and upload of documents, and communicate with relevant parties (e.g., Site Staff, SSU Lead) the status of documents; participate as the SED 2nd Reviewer as necessary.
• Support the SSU Lead to develop the regulatory approach for IRB/EC approval at specified regional levels, including country level approval, and participate in local approval activities.
• Coordinate the informed consent form (ICF) development, including the review, negotiation and approval with relevant internal and external parties.
• Partner with the SSU Lead to identify and execute the suitable timing of handoff to Clinical Operations on a site-by-site basis.

Requirements

• Bachelors Degree along with at least 1 year of industry related experience.
• Good knowledge of clinical research process related to study start-up and medical terminology and an understanding of Regulatory and Central/Local ethic submission processes for assigned countries; working knowledge of current ICH GCP guidelines and applicable regulations.
• 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.