Study Start Up & Feasibility Specialist

Study Start Up & Feasibility Specialist

Job Details

Description

Description

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

Qualifications

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.