[Remote] Clinical Operations Specialist

Note: The job is a remote job and is open to candidates in USA. Lexitas Pharma Services is a purpose-driven organization focused on ophthalmic product development. They are seeking a Clinical Operations Specialist to support study management, manage clinical trial documents, and facilitate essential documentation for clinical trials.

Responsibilities

• Site feasibility process (e.g., questionnaire development, collection, and tracking)
• Contribute to creating Study Informed Consent template and route for Clinical Lead and Sponsor review for approval prior to central IRB submission
• Complete Local ICF Site and Study Level Checklists and route for Clinical Lead review and approval prior to central IRB submission
• Develop other patient-facing materials (e.g., subject diary, questionnaires, etc.)
• Prepare and manage central IRB submissions - liaise with central Institutional Review Board (IRB)
• Update site-specific information in CTMS
• Liaise with the Project Specialist (PS) to draft the site section of the eTMF Plan
• Contribute to development of Regulatory Binder Table of Contents and template study logs and forms
• Track site activation activities
• Collection of regulatory documents from site
• Ancillary supply management at the site level, including ordering, reconciliation, re-supply requests, Regulatory Binder contents, and printed materials
• Follow up with sites on pending items needed for site activation
• Draft and send site activation letter to site upon approval from Clinical Lead
• Administer site enrollment surveys
• Perform ongoing site file reconciliation
• Perform eTMF audits and reviews
• Send mass study communications to sites after review and approval from the Clinical Lead
• File and maintain all site level documents in the eTMF
• Contribute to creating the Monitoring Plan for Clinical Lead review and approval
• Provide final EDC subject data to sites with support from the CTA
• Provide Site Reconciliation Reports
• Run Study User Access Reviews
• Perform eTMF document QC
• Perform debarment checks on potential Study PIs and record findings in CTMS
• Open and close file reviews in eTMF

Skills

• BA/BS in a science/health care field, nursing degree, or equivalent combination of education and experience
• Competent computer skills including MS Office Suite
• Customer service oriented
• Demonstrates good communication skills (written and verbal)
• Attention to detail
• Manner of interactions demonstrates an understanding of the value of developing positive relationships
• Ability to plan and organize information and activities as directed by a Project Manager or team member
• Able to resolve routine problems and elevate issues appropriately
• Able to work remotely in a fast-paced environment that requires effective multi-tasking and ability to easily adapt to changing priorities
• Works well as part of a dynamic project team, actively supporting other team members and identifying opportunities to contribute
• Position requires ordinary ambulatory skills and physical coordination sufficient to move about conference or meeting locations as required
• Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time
• Manipulation (lift, carry, move) of light to medium weights of 10-35 pounds
• Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time
• Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time
• Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time
• At least 1 to 2 years of clinical research coordinating experience or experience working in a contract research organization (CRO) or pharmaceutical or biotechnology company
• Experience working with eTMF and EDC systems

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