Clinical Research Co-Op

SUMMARY 

The Clinical Research Co-op will be responsible for implementing and coordinating clinical trials on multiple projects. The individual will conduct tasks related to clinical trials/studies supporting product development.  They will collaborate with other staff in the research setting to help encourage best practices in regard to integrity of study data documentation and collection. This is a full time position with a duration between 4-months to 1-year. 

RESPONSIBILITIES 

• Assist in programming and setting up clinical databases, case report forms (CRFs), and electronic data capture (EDC) systems for multiple medical device clinical trials
• Assisting with subject identification, patient recruitment, and scheduling of patient visits with study staff
• Collect and organize patient data, which may include acquiring past medical records, obtaining informed consent, and administering study questionnaires
• Assisting clinical staff during study procedures and shipping/processing tissue specimens
• Documenting patient visits and procedures; maintaining records and databases
• Perform data entry and analysis and generate relevant reports
• Assisting with FDA submissions and regulatory binders
• Writes articles and summary papers of studies for submission to medical journals as needed/requested
• Adheres to Good Clinical Practice (GCP) and follows all Standard Operating Procedures

QUALIFICATIONS

• Currently enrolled in an undergraduate program
• Prior hands-on experience with data entry in a lab or clinical research environment preferred
• High level of professionalism ensuring patient confidentiality and ethical handling of medical information including HIPPA
• Proficient in the use of Microsoft Excel, Word, and PowerPoint
• Experience with data entry and analytics
• Excellent communication, organization, time management, and interpersonal/team skills
• Ability to work independently

WORKING CONDITIONS AND PHYSICAL EFFORT 

The work environment characteristics described here are representative of those a Clinical Research Co-op encounters while performing the essential functions of this job. 

Physical Demands/Efforts

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Tasks involve the ability to exert light physical effort in sedentary to light work, but which may involve some lifting, carrying, pushing and/or pulling of objects and materials of light weight (25 pounds). Tasks may involve extended periods of time at a keyboard or work station.
• Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of instructions or diagrams and deal with several abstract and concrete variables.
• Visual demands are those of a typical office environment and extensive computer usage as well as research labs.

Mental & Visual Demands

• This position requires attention to detail and managing multiple tasks.

Work Environment and Hazards

• Absence of adverse conditions found in a typical office environment. Will be exposed to clinical and research and development labs.
• Familiar with university laboratory or hospital setting protocols for experiments involving agents of moderate potential hazard to personnel and the environment.
• Traveling by car, train and/or plane may be required