Grifols Shared Services North America, Inc Clinical Trial Lead in San Diego, California
Grifols is a global healthcare company whose mission is to improve the health and well being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
Clinical Trial Lead leads and manages the clinical operations of clinical trials.
Primary Responsibilities for Role:
Oversees clinical monitoring activities of moderate to complex clinical trials.
Provides clinical operations guidance to Clinical Trial Assistants (CTAs) and Clinical Research Associates (CRAs) as needed.
Promotes operational efficiency, teamwork and high morale amongst CTAs and CRAs.
Communicates monitoring and site management updates or issues to team.
Proactively prevents and identifies issues related to the clinical portion of the study, including study processes, monitoring or site issues.
Develops clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables.
Sets up and maintains Clinical Monitoring tracking tools and develops study tools and templates for monitors and site personnel.
Develops the study Clinical Monitoring Plan and ensures CRA compliance.
Reviews monitoring visit reports and assures adherence to study timelines for report submission and finalization.
Participates in site start-up activities, including site selection and regulatory document collection, review, approval and tracking, and the development of informed consent forms, template source documents, study manual, regulatory binder and other study related documents.
Develops study specific CRA training materials. Trains CRA team and tracks and maintains documentation of training throughout the life of the project.
Works with Clinical Program Management to identify and manage appropriate CROs and study suppliers.
Generates and utilizes metrics tools to assure study is running per timelines and to alert CRAs to potential issues (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports).
Works closely with line and department management for resourcing issues and escalates pertinent CRA performance and site compliance issues when necessary.
Presents and participates in Investigator Meetings, other study trainings and meetings as required.
Act as mentor and co-monitor with CRAs to ensure high quality as required.
Assist with the monitoring of difficult sites or studies that may be too challenging for a less experienced CRA.
Knowledge, Skills, and Abilities:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required:
Advanced knowledge of clinical trial practices and regulations.
Advanced knowledge of clinical monitoring management and trial design.
Advanced knowledge of clinical trial databases.
Proficient computer skills.
BA or BS degree
8-10 years or related experience
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
Learn more about Grifols at http://www.grifols.com/es/web/international/home