The Project Support Analyst plays an important role in the completion of events within study workflows during the active phases of clinical trial management and is responsible for ensuring that data submissions are appropriate blinded for PHI/PII, properly labeled, translated, and prepared for adjudicator review.

Primary Responsibilities

The Project Support Analyst is generally tasked with actions related to the completion of events within study workflows during the active phases of clinical trial or study management, including but not limited to:

• Understand and adhere to study-specific guidance related to source document redaction and QC requirements; Understand and adhere to GxP related to source document processing.
• Provision customer user accounts within assigned studies/trials
• Perform and assist with the management and completion of events within the system such as Workflow Run creation, resumption, cancellation, completion and step assignment.
• Perform image, video or document quality review, redaction, and/or source preparation as specified by study-specific parameters and documented instructions, within required study timelines.
• Facilitate Source Document translation when required
• Create DICOM image links
• Become proficient in the use of provided tools (including but not limited to SightHound, PDF redaction tools, and others) to perform redaction of submitted source documents of various formats.
• Issue queries and perform routine follow-up with study sites for resolution, informing Clario Project and Operations managers of trends or issues jeopardizing study timelines.
• Assist with the generation and distribution of final study closeout deliverables
• Collaborate with cross-functional team members and authorities to ensure the specification and use of appropriate tools is identified and adhered-to.  Attend project/team meetings as needed.
• Appropriately set and fulfill Clario Project Management and customer expectations related to completion of assigned tasks.
• Relentlessly pursue the highest quality output, professionalism, collaborative attitude and accountability to meet commitments.
• English fluency, in both written and verbal communication.

Secondary Responsibilities

Maintains Quality Service and Departmental Standards by:

• Reading, understanding, and adhering to organizational Standard Operating Procedures (SOPs) and various study-related documents (i.e., study charter, Project Specific Work Instructions, etc.)

• Participating in the modification of company SOPs
• Participating in the development of team SOPs, QRGs, and Work Instructions.

Contribute to team effort by:

• Working with internal staff to resolve issues
• Helping others to achieve results
• Performing other duties as assigned

Maintain technical and industry knowledge by:

• Attending and participating in applicable company-sponsored training
• Maintaining a strong understanding of industry trends and applicable technology

Qualifications:

Education

• High School Graduate or Associate/Bachelor’s Degree in computer science, information technology, information technology or equivalent work experience

Experience

• 0-2 years in clinical trials, healthcare or a related field. 1 year or more of related clinical trial work experience preferred.
• Experience working with computer software including the MS Office suite (Word, Excel, Teams, OneNote).

Additional skill set:

• Ability to read documents in English and to identify deviations from Good Documentation Practice, specifically as it relates to identifying PII/PHI to be redacted from clinical trial source documents.
• Excellent attention to detail and meticulous work
• Ability to work both in a group setting and independently
• Ability to adjust to changing priorities and to handle difficult or stressful situations with professionalism, initiative and good judgement
• Ability to organize and prioritize assigned tasks to meet established schedules, timelines, or deadlines
• Excellent problem-solving abilities and dedication to quality work output
• Strong interpersonal and communication skills (both verbal and written)
• Ability to maintain a professional and positive attitude at all times