Clinical Research Associate
|June 12, 2013 - June 30, 2013|
|Employment Type:||Full Time|
|Description:||Schedule and conduct monitoring activities at assigned centers assessing site compliance to assure adherence to good clinical practices, standard procedures, and study protocols. May participate in the study development and start-up process.|
|Duties:|| Schedule and conduct monitoring activities at assigned centers assessing site compliance to assure adherence to good clinical practices, standard procedures, and study protocols. |
Discuss monitoring visit findings with site personnel and complete written reports.
Identify and track monitoring action items.
Review regulatory documents.
May participate in the study development and start-up process.
Review protocols, design and/or review CRFs, prepare Informed Consent forms, develop study
documents, organize and present at investigator meetings, work with management on monitoring strategy, and/or develop specific training.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position. They are not intended to be an exhaustive list of all essential or non-essential functions and skills, knowledge and abilities required of employees so classified.
Job duties and requirements may be subject to modification to reasonably accommodate individuals with disabilities. Requirements are representative of the minimum levels of education, experience and skills required to perform the essential functions of this job. The job description does not constitute a written or implied contract of employment. MMRF reserves the right to change job duties and responsibilities as the need arises.
Any equivalent combination of education and experience that provides the required knowledge and skills is qualifying. Typical qualifications would be a Bachelors degree in Medical Sciences, Nursing, or related field, and 1-2 years experience in clinical research. Experience in clinical research monitoring preferred.
Skill, Knowledge & Ability (SKA):
Requires interaction with a diverse population. Ability to travel an average of 65% depending on project needs. Skilled in problem solving and keeping detailed records and files. Demonstrate proficiency in word processing, spreadsheet, and presentation computer software applications. Knowledge of research design, protocols, and analysis; and knowledge of regulatory aspects of clinical research. Ability to produce professional correspondence, presentations, reports and training materials. Ability to recognize reportable adverse events when reviewing patient charts. Ability to constructively interact with range of personalities and positions both inside and outside the organization. Ability to work independently, be self-directed and motivated, and communicate effectively. Displays high standards of attendance, punctuality, maintains confidentiality, effective time management.
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