Clinical Study Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Clinical Study Specialist (CSS) is responsible for providing operational support to the Clinical Study Associate (CSA) across multiple molecules for Investigator Initiated Studies in accordance with Genentech (GNE) US Medical Affairs SRT Charter (current version), Roche SOP-0108812 (current version), and all Federal regulatory, safety, and Genentech legal requirements. The CSS works directly with the CSA and project team to ensure that specific deliverables are completed in accordance with contract and Genentech’s expectations. The CSS will complete tasks as per the Genentech IIS RACI guidance document

Study Start-Up, New proposals and Protocol Review

• Drafts Proposal Synopsis Approval and Study Introduction Letters.
• Requests CDA if needed or if CDA is currently already in place, drafts Confidentiality Reminder Letter to the PI.
• Completes the Study Introduction letter and packet for CSA review.
• Add New Team information including PI Contact in gSTARS.
• Set-up Investigator Files in GNE central file repository and begin filing documents.
• Generates draft PI Protocol Approval Letter for CSA.
• Requests IND Cross Reference Letter from GNE Regulatory (if applicable).
• Request CTV Letter from USDS and files the letter in the GNE central file repository

Site Activation

• Generates DRAFT Study Activation Packet documents which, include updating the following: (Site Activation Letter, Drug Signature Form, Drug Request Form, Enrollment Log Template, CTV Letter from GNE Safety, and CTV Template).
• Uploads Drug Approval Signature Form in central file repository

Maintenance

• Communicates with sites monthly for collection of enrollment logs and files into GNE central file repository.
• Reviews and updates accrual information in gSTARS & CTMS.
• Completes the collection of protocol amendment documents and
• the generation of draft Protocol Amendment Letter (if applicable) for
• CSA review.
• Reviews GNE central file repository on a routine basis to ensure all documents have been filed within specified timeframe and naming conventions are correct (follows QC Process).
• Processes ongoing site drug requests with oversight from CSA. (NOTE: CSA is responsible for initial drug request/shipment.)
• Files received IRB renewal documents. QCs filing ensuring all expected IRB renewals are on file and follows up with site staff to receive expected documents.
  • Enters IRB renewal dates into gSTARS

Study Conclusion

• Prepares draft IIS Close-out Preparation Letter.
• Distributes Close-out Preparation Letter once approved by CSA.
• Completes the IIS Conclusion Checklist Form for CSA review and uploads final version to GNE central file repository.
• Collect and reconcile final site documents/regulatory documents prior to filing final documents.
• If any of the Conclusion Checklist items are incomplete, generates
• a Note-to-File. (CSA and/or CSM MUST review NTF for content).
• Send Study Conclusion Letter to site for PI signature (if study Conclusion Letter is NOT returned by PI within 3 attempts, the CSS will generate a Note To File).
• Files FSR/Publication in GNE central file repository.
• Closes out investigator study file in GNE electronic file repository and marks closed next to ML study number. Downloads documents to desktop and uploads to the GNE closed file repository mirroring the existing file folder structure. Performs a quality check to ensure all documents are in the repository prior to deleting from the current file repository.
• Moves closed study files to Recpoint. (Please note: Recpoint will transition to OneArchive August 2022)

Meetings

• Mandatory attendance at monthly CSA meeting.
• CSA and CSS will meet minimally every other week and/or ad hoc as needed.
• CSS, CSA, and CSM may meet as applicable.
• May attend other Ad Hoc team meetings as applicable.

Qualifications:

Training and Education Required:

• Completed Bachelor’s degree or international equivalent in business, finance, health sciences, or related field
• Must read, write and speak fluent English
• 6 months – 2 years remote office-based experience (home office set up)

Prior Experience Preferred:

• Demonstrates some knowledge of clinical research industry
• Demonstrates basic knowledge of office environment and related systems
• Demonstrated experience working in a portal space with electronic documents
• Demonstrated project administrative support or equivalent
• Demonstrated experience working independently and problem solving

Skills:

• Must be independently resourceful (using tools and guides provided to get the job done)
• Exceptional organizational skills and being able to prioritize critical timelines with little oversight
• Excellent communication skills, both written and verbal. Understands medical, clinical and scientific terms
• Detail oriented & possesses technical expertise (e.g., spreadsheets, metrics & data flow
• management) including portals

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.