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Lexitas Pharma Services · 5 hours ago

Clinical Operations Specialist

United States

Full-time

Remote

Entry Level

$78K/yr - $83K/yr

1+ years exp

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.

BiotechnologyClinical TrialsHealth Care

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

Qualification

Clinical research coordinationETMF systemsEDC systemsMS Office SuiteCustomer serviceCommunication skillsAttention to detailOrganizational skillsProblem-solvingTeam collaboration

Required

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

Preferred

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