[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 Company Overview Lexitas Pharma is a full-service CRO partnering with pharmaceutical and biotechnology companies specializing in ophthalmics. It was founded in 2011, and is headquartered in Durham, North Carolina, USA, with a workforce of 51-200 employees. Its website is