Lead Clinical Research Associate

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Job description

Job Description

The Lead Clinical Research Associate is responsible for the delivery of all clinical aspects of clinical studies. The Lead CRA provides operational expertise, and to ensure the effective and efficient delivery of all aspects of multiple studies, through all phases of clinical study management, in accordance with Standard Operating Procedures (SOPs), current Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and applicable local regulation.

Essential Duties and Responsibilities :

• Contribute to all clinical research activities to ensure successful management of clinical studies.
• Maintain and track clinical study data and support in investigator qualification and selection, analysis of potential patient recruitment, and overall study status/progress throughout the life of a study.
• Manage site start-up/activation process, including:
  • Heavy contribution to the preparation of study related documents (protocols, case report forms (CRFs) or eCRFs, draft informed consent forms (ICF) and complete checklists, able to support in clinical trial agreements and budget negotiation, clinical monitoring plan),
  • Organizing IRB/EC submissions and applicable regulatory documentation with follow through to ensure successful outcomes.
• Perform on-site and remote site qualification visits, site initiation visits, interim monitoring visits and site close out visits
• Conduct clinical study monitoring to ensure regulatory and protocol compliance as well as overall data accuracy in accordance with the study clinical monitoring plan.
• Complete source data verification of clinical study data entered in an Electronic Data Capture (EDC) system or on a case report form at sites to ensure regulatory and protocol compliance and overall accuracy.
• Serve as main liaison to participating clinical trial sites with focus on data entry, query resolution, investigational device tracking and accountability, and study conduct oversight at the participating clinical sites.
• Collaborate with data management to support data cleaning process
• Lead review of safety events and collaborate on development of narrative and reporting as needed
• Develop and manage study trial master file and maintain study documentation and clinical trial management system (e.g., correspondence, CRFs, study approval documents), trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget, etc.)
• Track, process and manage site payments and support in study financial tracking by developing tracking tools as necessary.
• Assist Clinical Study Manager/Director on study scoping activities, including but not limited to development of pre-study questionnaires, study design and site selection
• Support site audits and site audit preparation in anticipation of site inspections

Job Requirements

• Life sciences bachelor's degree or certification in a related allied health profession from an accredited institution (e.g., nursing, medical or laboratory technology) or equivalent
• Clinical research/clinical trial management certification/education preferred
• Minimum 5 years of experience in clinical trial operations and monitoring required, experience with CNS clinical trials strongly preferred; neuropsychiatry/schizophrenia recommended; clinical audit experience also recommended
• Experience working with electronic data capture (EDC) systems required
• Possess advanced knowledge of Clinical investigation of medical devices for human subjects - Good Clinical Practice (ISO 14155), 21 CFR Part 11, 50, 54, 812 and other applicable regulations
• Must be clinically savvy and possess time management, organizational skills and problem-solving skills.
• Excellent written and oral communication skills and interpersonal skills with high attention to detail
• Ability to work successfully in a team environment and ability to prioritize and manage multiple tasks as necessary.
• Proficiency in Microsoft Office Suite, PDF application
• Experience working with electronic data capture (EDC) systems required
• Available to travel if/when needed