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 https://www.lexitas.com/.
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