Lexitas

Supports study management by handling documentation, site coordination, and communication with sites and IRBs. | Requires 1-2 years of clinical research experience, proficiency with MS Office, and attention to detail. | Overview Provides support to Study Management and other study team members. Responsible for in-house site management. Manages all protocol-level and investigator-related clinical trial documents, study supplies, and vendor information. Keeps study-related essential documentation current and filed. Facilitates collection and review of essential documents, budgets/contracts, and IRB documentation on behalf of sponsor and site. 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 Requirements Education: BA/BS in a science/health care field, nursing degree, or equivalent combination of education and experience Experience: 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 is preferred Competent computer skills including MS Office Suite Experience working with eTMF and EDC systems is preferred Skills: 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 Physical Requirements 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. Disclaimer: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. Lexitas Pharma Services, Inc., at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Lexitas Pharma Services, Inc., at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Lead and oversee clinical data management activities including managing teams, ensuring data quality, vendor oversight, and communication with stakeholders. | 6+ years clinical data management experience in CRO, expertise in EDC platforms, knowledge of clinical research operations and regulatory requirements, strong management and communication skills. | Overview Provides operational data management project leadership and oversight to Clinical Data Leads (CDL’s) and Clinical Data Coordinators (CDC’s). Must be an expert in the technical responsibilities of the position. Manages the data management deliverables, ensuring that the quality of data is consistent with the sponsor and departmental expectations and aligns with the study protocol. Responsibilities Provide oversight of Clinical Data Leads and Clinical Data coordinators in the planning, implementation, and closeout of data management activities for clinical research projects. Ensure that project activities are produced according to the study scope, budget, and timelines. Oversight of external data management resources and vendors if any data management study activities are being performed by another service provider. Oversight and review of all database development activities including, but not limited to, eCRF development, Data Validation Specifications development, eCRF Completion Guidelines development, User Acceptance Testing, and Data Management Plan development. Work actively with the clinical and data management study teams to review study data and ensure data quality. Identify and escalate any risks to database integrity, study timelines, and resourcing to the appropriate individuals. Responsible for communicating with internal study teams, sponsor study teams, and study stakeholders on data management progress, timelines, issues, and risks. Participate in and lead client team meetings with respect to data management activities as needed. Ensure appropriate training to the study team on the use of electronic data capture technology Requirements Education: Required: a B.S./B.A. or advanced degree Experience: A minimum of 6+ years of clinical data management experience, preferably in a CRO setting. Experience leading multiple studies in a client facing role. Experience leading departmental initiatives preferred. Skills: Experience with two or more commercial Electronic Data Capture platforms preferred. Must have a good understanding of clinical research operations including GCP and regulatory requirements and operational procedures Experience in ophthalmology preferred Experience in a CRO setting is strongly preferred Must be highly customer service oriented and have creative initiative with a positive attitude Understands and shares the organizational values of developing and maintaining good relationships internally and externally. Quality of interactions reflects emphasis on relationships Able to work in a fast-paced environment and easily adapt to changing priorities Must have excellent management and communication skills (written and verbal), strong problem-solving skills, and be detail oriented Advanced skills in computer operation, spreadsheet creation/maintenance, word processing and electronic data captures systems are essential Physical Requirements 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. Disclaimer: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. Lexitas Pharma Services, Inc., at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Lexitas Pharma Services, Inc., at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.