[Hiring] Study Lead I, Lead Management @Sarah Cannon Research Institute

Role Description

The Study Lead serves as the primary responsible party and point of contact during clinical research trial feasibility, clinical operations review, and document collection up until the point of site selection. The Study Lead is expected to be an experienced and fully competent team member who is able to complete role independently or with minimal supervision. The Study Lead provides resolutions to a diverse range of complex problems by working with sponsors/CRO and other internal stakeholders to expedite the Lead Management process. Additionally, the Study Lead will work with clinical operations staff and other resources to assess site capabilities and fill out feasibility questionnaires on behalf of SCRI strategic sites. The Study Lead will coordinate with sponsors/CRO and internal teams to obtain all essential documents that are required for study activation and will present during operational review meetings.

• Support essential education and training to sponsors/CRO via kick off call/email by providing capabilities presentations and addresses client questions & concerns
• Support clinical operational review and attend site calls to review study opportunities
• Conduct comprehensive feasibility for clinical study leads using internal data and personnel as resources
• Collaborate with cross-functional teams to gather necessary data and information for feasibility analysis
• Maintain tracking system for study lead life cycle
• Other duties as assigned

Qualifications

• Bachelor's Degree
• 4+ years of relevant experience
• 1+ years of trial management experience
• Knowledge of pharmaceutical industry, regulatory process, clinical trials and medical terminology
• Attention to detail, solid execution, meeting aggressive timelines, strong interpersonal skills and team player
• Excellent verbal and written communication skills
• Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials
• Ability to collaborate effectively with the study team, cross functional team members and external partners (including investigator and site staff) using collaborative negotiation skills
• Strong computer skills including knowledge of Microsoft Excel, Word, PowerPoint and Outlook
• Ability to work within established timelines, in a fast-paced environment

Requirements

• 2+ years of trial management experience (preferred)
• Certification in Clinical Research by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) (preferred)

Benefits

We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves.

• Competitive compensation package determined by performance, experience, skills, equity, and geographical markets
• Annual bonus or long-term incentive opportunities may be offered

Company Description

Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI’s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S.