Study Lead I

Sarah Cannon Research Institute

1d•Onsite

About The Position

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.

Requirements

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.
Practices and adheres to the “Code of Conduct” philosophy and “Mission and Value Statement.”
Routinely assigned training requirements. You are expected to complete any training assignments by the due date.

Nice To Haves

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

Responsibilities

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