Work Location: Newark, DE
Job Title: Senior Clinical Research Associate
Duration: 12 Months contract
Senior Clinical Research Associate (Senior CRA)
Reporting to a Sr Clinical Manager, assist the Clinical Project Manager or Senior Manager in the preparation and execution of clinical study tasks, including: documents (may include plan, protocol, report), initiation, monitoring, and completion of clinical studies for verification and/or validation of Client Healthcare Diagnostics in vitro diagnostic products (new or modified).
Represents the clinical affairs department on multi-functional core teams to ensure the project requirements are met and clinical trials are conducted successfully. Also may function as clinical affairs leads on project element teams, when applicable.
Ensures adherence to Good Clinical Practice (GCP) and department standard operating procedures for conducting device clinical studies.
Essential Duties and Responsibilities
Other duties may be assigned.
- Under supervision of Clinical Affairs Sr. Manager or Project Manager, works with relevant departments (R&D, Regulatory Affairs, Medical Affairs, Validations, Product Support, Marketing) to aid in design and preparation of clinical and analytical in vitro diagnostic device performance study plans, protocols, and reports, statistical data analysis plans, and associated study data collection forms.
- Remains current with regulatory requirements for in vitro diagnostic products.
- With minimum supervision, completes all activities related to the set-up, initiation, execution and close-out of in vitro diagnostic device clinical trials including collection, timely review and analysis of data generated.
- Schedules and completes on-site monitoring visits to ensure protocol compliance, accuracy and completeness of clinical data.
- Communicates with study investigators via phone, fax, email and/or letters regarding activities in all phases of the study. Develops and maintains ongoing relationships with investigators/institutions/vendors with access to specimens needed in clinical trials.
- Completes the coordination with biostatisticians and data managers to manage incoming clinical site data, design/maintain databases, and ensure integrity of the database.
- Provides up-to-date clinical study progress reports.
- Negotiates site specific study budgets, initiates and oversees contract origination, compliance approval, and execution.
- Completes the tracking of budgets for studies.
- Represents Clinical Affairs on multifunctional team tasked with preparing responses to regulatory agencies.
- Represents Clinical Affairs on multifunctional team tasked with the preparation of scientific abstracts, posters, and publications reporting results of the clinical studies.
EDUCATION and/or EXPERIENCE
B.A./B.S. or equivalent; three to five years related experience and/or training; or equivalent combination of education and experience.