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Objectives of the Position
To ensure timely implementation of clinical research plans for assigned products
To ensure investigator and site compliance with the study protocol, FDA regulations, ICH Guidelines and Good Clinical Practice (GCP)
To coordinate and execute clinical research activities for multisite clinical studies
Support the evaluation of RMS products
Description of Responsibilities;
Clinical Research Associate
Works under general supervision, and participates in the design, planning, implementation and overall direction of clinical research projects; May co-ordinate the activities of relevant colleagues within the Company and investigators to ensure compliance with the overall scientific study objectives. May work with international investigators and key customers as well.
Receives general instructions; plans and prepares studies.
Travels to field sites to monitor studies.
Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents
Monitors the sites and provides technical assistance, as necessary.
Works with Data Management and Biostatistical staff on the design of documents and processes for the collection of study data from participating sites.
Assumes accountability for the collection and maintenance of regulatory documentation, as applicable.
Assists with the coordination of training and certification of study site personnel.
With guidance, ensures accurate and complete study management/data collection and transfer into the data management system.
Ensures site compliance with the study protocol, FDA regulations, ICH Guidelines and Good Clinical Practice (GCP)
< > material logistics for the studies.Conducts reference material testing in-house.
Supports the organization of investigator meetings, as necessary.
Makes sound recommendations to solve problems
Establishes, as appropriate, internal/cross-functional/customer relationships.
Uses discretion and independent judgement to recommend solutions to basic problems that the individual or team projects.
Assists, prepares and manages study timelines.
Participates in Project Team Meetings.
Keeps informed of trends and developments in clinical research.
Knows and effectively uses the broad concepts of a particular field or specialization to resolve problems of limited scope and complexity.
Analyzes alternative approaches to solve problems or devleop new perspectives on existing solutons.
B.S. or M.S. in Biology, Chemistry, Molecular Biology or related discipline.
Clinical Research Associate:
Typically requires 2-6 years relevant clinical research experience, 4-6 years preferred.
The candidate must be an extremely detail oriented "people person , a self starter with excellent lab skills. He or she must be able to work in a team situation, have the ability to solve problems in a detailed, comprehensive manner, demonstrate urgency and energy to handle problems, meet timelines and manage sites. He or she must have excellent written and verbal communication skills, and good presentation skills. Additionally, MSWord, Excel, and Powerpoint skills are required.
Able to accommodate 15-35% travel during occasional peak periods.
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