Study Start-Up Associate

Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.

We are currently hiring a Study Start-up Associate to join our team! As an SSUA here at Rho, you’ll have the opportunity to coordinate study start-up activities including investigator assessment and identification, pre-study development, site qualification, and site activation. You’ll 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.

Our Study Start-Up team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group!

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
  
  

Qualifications

• 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.
  
  

A Few More Things To Know About Us

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.

Diversity and Inclusion: As a global, full-service CRO driven by our collective experiences, we view each of our backgrounds as a vital component in our formula for success and we strive towards building a more equitable, inclusive, and diverse environment for our employees every day. By valuing and tapping into each employee’s unique and different personal experiences, we are able to uplift employee dignity and belonging, foster more strategic creativity, and more quickly arrive at breakthrough solutions that help us heal the world.

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

As required by pay transparency laws in some states, Rho provides the range of starting compensation (annual salary or hourly rate) it reasonably expects to pay for a given role. Actual compensation is influenced by a wide array of factors including but not limited to role responsibilities and location as well as candidate skill set and level of experience. The range of starting pay for this role is $45,000 - $65,000 per year.

EOE. Veterans/Disabled

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