Study StartUp Specialist

Description:

This role will focus on leading all aspects of study start-up activity until the point of site activation. The Study Start-Up Specialist will be responsible for overseeing and planning study start-up processes, collaborating with internal and external stakeholders, ensuring timelines are met with quality execution. The Study Start-Up Specialist acts as a subject matter expert on all start-up related activities and is involved in start-up process improvement.

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Primary Responsibilities: **

Accountable for study start-up for assigned clinical sites

Serve as the primary point of contact for start-up activities, resolving site queries, and assisting sites with all start-up related activities.

Collaborate with, but not limited to the following departments: Feasibility, Regulatory, Investigators, Project Management, Ratings, EDC, Laboratory, Pharmacy, Infusion, Finance, Marketing and Recruitment, Source, CTMS, and 3rd party vendors (out-patient procedures).

Supports study feasibility in close collaboration with Feasibility Specialist and Site Partnership Specialist as well as the global study team.

Collaborate with staff in Operational Strategy & Planning, Business Development and Operations to provide feasibility data and other relevant data.

Communicates effectively with project team members to ensure alignment of study start-up strategy and risk mitigation. Selects appropriate communication platforms to convey information effectively and efficiently. May present at intra-/inter-departmental meetings.

Ensures that clinical delivery project team members and any other cross-functional team members needed to support site activations understand responsibilities and performance standards.

Collect, review, track and complete start-up related documents like Site Contact and Site Information forms, in accordance with sponsor processes and timelines.

Assist in resolving site queries and provide regular updates, escalating issues to the operation specialists.

Attend weekly start-up meetings with key stakeholders.

Maintain start-up tracker with timely updates.

Forecast and track metrics and progress of study start-up, ensuring all sites are greenlit on time.

Interface with Client representatives and internal departments to ensure timely initiation and completion of clinical trials.

Identify potential bottlenecks and develop contingency plans to keep projects on schedule.

Coordinate client meetings, schedule internal meetings, and conduct daily communication via telephone and email.

Discuss draft ICFs re all required elements prior to IRB submission.

Educate Project Specialists and department specialists on relevant study and protocol related information.

Provide logistical support to clinical trial supply coordination.

Collaborate and share information with other sites in the network who will be working on the same study as distinct sites or satellite sites.

Coordinate scheduling of Pre Site Selection Visits (PSVs), Site Initiation Visits (SIVs) and Kick-Off Meetings (KOMs). Ensuring relevant staff are aware and invited.

Ensure appropriate staff are registered for Investigator Meetings (IMs). Attend IMs if needed on occasion.

Ensure accuracy and timeliness, keep track and enter study timelines and dates in systems as needed (CTMS, Devana LYNK, SharePoint).

Mentor junior Study Start-Up Team members.

Ensure physicians at research sites are prepared to begin studies and have all the tools they need to do so.

Develop and update relevant training documentation, and conduct training where necessary.

Ensure all activities within competence are carried out in line with the international ethics and quality standards, current regulations, applicable guidelines and SOPs (Standard Operating Procedures).

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Knowledge, Skills, Abilities: **

Thorough knowledge of clinical study start-up processes and requirements.

Experience with investigator start-up documents and investigative sites.

Experience in working with cross-functional teams.

Understanding of clinical research processes, site logistics, and study start-up.

Strong digital literacy, ability to analyze data, and multitasking skills.

Proficiency with Microsoft Office Products – Word, Excel, PowerPoint, SharePoint, PowerPoint.

Effective organizational and time management skills.

Ability to multitask under limited direction and on own initiative.

Strong communication and interpersonal skills.

Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues

Highly responsive, proactive, and a team player.

Qualifications:

University/College degree or certification in a related allied health profession.

Minimum of 1 year of relevant clinical trial experience with a clinical research site or CRO.

Familiarity with ICH/GCP requirements and FDA guidelines.

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