Clinical Research Associate (CRA)

Company: Planet Pharma
Location: Santa Clara
Posted on: June 21, 2022

Job Description:

WHAT YOU'LL DO The Clinical Research Associate (CRA) designs, implements and monitors clinical studies of new and modified in vitro diagnostics products. Ensures that the clinical studies are designed to validate product performance claims and supports products "intended use. Prepares clinical data reviews and data summaries. Participates in the preparation of regulatory submissions and international registration packages. Support process improvement initiatives within Clinical Affairs and support ongoing in-house clinical activities. In general, the CRA performs responsibilities and tasks under the direction of a SCRA or CPM. Main responsibilities include: * Implements and maintains the effectiveness of the Quality System.
* Complies with all policies, established procedures and regulations related to clinical research
* Actively participates as a member of the cross-functional project team
* Prepares design validation plans
* Prepares documents for clinical studies
* Identifies and qualifies clinical investigators and clinical sites
* Proposes and negotiates budgets for clinical studies, initiates payments to sites
* Obtains and reviews all required essential documents necessary for study initiation
* Review's data, prepares and presents clinical data reviews and data summaries
* Responds to audits and data queries
* Prepares the clinical sections of regulatory submissions and international registration packages
* Assists Regulatory in preparing responses to regulatory agencies' questions regarding the clinical study * Ensures timely collection of essential documents for all assigned studies, and verifying documents are filed appropriately within the study's eTMF according to procedures and regulations. May perform eTMF audits or QC checks to ensure inspection-readiness at all times; verify the quality of documents filed by ensuring documents are complete and accurate.
* Acquires a basic understanding of the principles of the assay and/or instrument and "hands-on" knowledge and skills in performing assigned assays or operating instruments * Arranges for and assists in standard Statistical Support with the collection and statistical analyses of clinical data * Monitors standard clinical studies ensuring site compliance with the clinical protocol and ICH/GCP guidelines, assures subject rights, safety, and welfare is protected, ensures data integrity through completeness, accuracy and legibility * Prepares and reviews product labeling and promotional materials
* Conducts standard pre-study initiation, interim and close-out monitoring site visits and completes site visit reports * Initiates standard clinical studies and provides for investigator and staff training
* Maintains accurate and timely sponsor/site correspondence and communication
* Prepares and presents project progress reports to keep management and team informed
* Supports publication or presentation of clinical data in professional journals or meetings
* Maintains professional, product and market expertise via independent reading, networking and training
* Accepts and completes all management-directed work assignments such as clinical assignments, travel, and other tasks Qualifications * Bachelor's degree B.S in biological sciences or medical specialty preferred.
* Minimum 3 years of clinical related experience
* Life sciences background and knowledgeable in good clinical practices, especially in medical devices or IVDs. Preferred * Clinical Laboratory certification (MT, ATCP or equivalent) or certification as a clinical research associate (CCRA)
* Site monitoring of investigational drug or device trials or clinical laboratory assay/instrument experience * Demonstrates good basic writing and presentation skills (i.e. clear, concise, effective and well organized) * Excellent interpersonal and communication skills, including building rapport with colleagues and management
* Ability to work with cross functional teams as well as the ability to be autonomous in driving work activities
* Organized, detail oriented, and excellent problem-solving skills with the ability to provide innovative solutions
* Familiar/experience with utilizing eTMF or CTMS systems
* Ability to manage multiple projects with conflicting priorities and have the flexibility to adapt to changing priorities.

Keywords: Planet Pharma, Santa Clara , Clinical Research Associate (CRA), Healthcare , Santa Clara, California