Study Start Up & Feasibility Specialist (30226)

Position purpose

The Study Start Up & Feasibility Specialist ensures rapid study start up and manages all aspects of the feasibility process across sites.

Responsibilities/Duties/Functions/Tasks:

· Manages client feasibility communications including site submission, completion of questionnaires, and other requests on behalf of assigned sites as directed

· Oversees the internal feasibility process ensuring essential data (EHR, CTMS) and key stakeholder feedback is incorporated

· Collaborates with legal and leadership to ensure the tracking, documentation, and signatures for all NDAs/CDAs are completed at the time of feasibility

· Ensures timely submission of, and follow up on, all feasibility questionnaires and site submissions to clients, while keeping CRM data updated and organized in real time

· Provides timely and thorough pipeline updates to clinic operations, regulatory, and contract teams at every stage of PSV, study awards and study start-up

· Attends PSVs to ensure continuity in prior communications, to capture study updates affecting feasibility, and to gather details and timelines related to study start up

· Drives PSV and study startup optimization via successful hand-off of study details and client communications to other departments. Leads PSV training efforts with clinical operations to close the sales cycle

· Owns all CRM data including upkeep of all internal research site information, current study updates, and new opportunity details in the study pipeline

· Provides scheduled and on-demand pipeline and departmental updates to leadership and local site teams

· Works alongside research leadership and Principal Investigators to determine study site selection

· Creates and maintains client facing presentations and marketing materials to showcase network capabilities

· Manages preparation, including any documentation needed, for any client meeting

· Maintains investigator CV addendums with updated clinical trial history

· Leads data entry process of business development activities in the CRM related to opportunity state progression through the entire study cycle

· Acts as the face of the network alongside physicians in various industry meetings

· Organizes, creates documentation for, and attends study kick off calls for all new studies entering study-startup

· Works with all shared service departments to drive rapid study start up. Supports client communications as requested after local site handoffs

· Is the central communicator between all shared service departments to ensure study start up tasks are on track and being completed on time

· Reports monthly start up metrics to leadership

· Maintains start up activities/communications within the CTMS system

· Supports other business development or start up functions as necessary

Qualifications

Education:

· Bachelor’s Degree from an accredited university preferred

Experience:

· Urology research experience preferred

· Minimum of 3 years of clinical research required

· Business development experience within the research industry preferred

Other Requirements: Travel within the United States may be required

 

Performance Requirements:

 

· Knowledge of grammar, spelling, and punctuation.

· Skill in operating office equipment.

· Skill in answering the phone and responding to questions.

· Skill in time management, prioritization, and multitasking.

· Skill in writing and communicating effectively.

· Ability to work under pressure, communicate and present information.

· Ability to read, interpret, and apply clinic policies and procedures.

· Ability to identify problems, recommend solutions, organize and analyze information.

· Ability to multi-task, establish priorities, and coordinate work activities.

· Ability to competently use Microsoft Office, including Word, PowerPoint, Excel, and appropriate practice management software.

 

Equipment Operated: Standard office equipment including computers, fax machines, copiers, printers, telephones, etc.

 

Work Environment: Position is remote with some travel to industry meeting and clinical research sites as needed.

 

Physical Requirements: Must possess the physical and mental abilities to perform tasks such as sitting for 90 percent of the day; manual dexterity to operate office machines including computer and calculator; stooping, bending to handle files and supplies; and mobility to complete errands or deliveries. Stress can be triggered by multiple staff demands and deadlines.