Study Designer

🕒 May 2

🐎 Kentucky – Remote

🐎 Kentucky – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

✍️ Designer

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CTI Clinical Trial and Consulting Services

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1999

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

CTI Clinical Trial and Consulting Services is a full-service contract research organization (CRO) that provides clinical trial execution, regulatory strategy, lab and bioanalytical services, real-world evidence generation, and research center management to biotech and pharmaceutical sponsors. With expertise across Phase I–IV studies and complex therapeutic areas (including rare diseases, cell and gene therapy, oncology, neurology, and transplantation), CTI supports study design, site management, patient recruitment, monitoring, safety/pharmacovigilance, biometrics, and quality assurance. Headquartered in Covington, KY, the company emphasizes integrated, patient-centric approaches and global regulatory guidance to accelerate development and bring therapies to patients.

📋 Description

• Translate all documented customer expectations in the CTI Laboratory Services database to provide seamless services • Leverage technical, therapeutic area, client and CTI Laboratory Services process knowledge to provide a comprehensive review of the protocol • Liaise with internal departments along with the Laboratory Project Manager to understand CTI Laboratory Services capabilities and assess the feasibility of requests to meet client needs related to study design • Manage and solve technical changes, issues and concerns of high complexity work with little to no guidance • Displays strong interpersonal and communication skills that will build strong internal relationships to ensure high quality study design • Responsible for delivering quality technical services related to assigned clients. Ensure the consistent use of SOPs • Performs quality self-review in addition to review for other Study Designers when requested • Able to act efficiently in an environment with dynamic timelines and priorities • Displays appropriate self-organization and ability to manage conflicting priorities • Leads and participates in functional meetings and provides input, keeping processes up to date • Act as a Technical Expert by participating in process improvement initiatives • Other duties as assigned

🎯 Requirements

• Associate degree (or equivalent) with at least 2 years of relevant central laboratory experience or 4 years relevant central laboratory experience • Strong planning, organizational and problem solving skills • Strong verbal and written communication skills • Effective negotiator in complex and uncommon situations • Strong computing skills, especially databases • Great communicator with strong written and verbal fluency in English • Detail oriented to drive tasks to completion • Ability to work well in a rapid-paced startup environment • Ability to work well in a group

🏖️ Benefits

• We support career progression – 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward • We value education and training – We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department • We value our people - We have never had a layoff in our 20-year history, support a work-life balance with flexible schedules, and have provided cash bonuses every year for the past decade • Our culture is unparalleled – Click here to learn more about “The CTI Way” • We think globally and act locally – We have a global philanthropic program supporting our team’s efforts to improve their local communities (Click here to learn more about our “CTI Cares” program)