Study Start-Up Specialist - K2 STAFFING LLC

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.

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 3^rd 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).

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.