ESSENTIAL DUTIES AND RESPONSIBILITIES
In close collaboration with the Clinical Research Coordinator and Principal Investigator, the incumbent will serve as support staff to the clinical research department in clinical trials, following company SOPs, ICH GCPs, protocols, all regulator laws, including but not limited to Food and Drug Administration (FDA) Code of Federal Regulations and state laws. Some weekend, overnight, and evening hours potentially required. While some remote work may be acceptable, this is a primarily in-person position and regular attendance is required.
This position will fulfill the following specific functions:

1. Work closely with the Clinical Research Coordinator, Principal Investigator, and other research staff to become thoroughly familiar with and develop the ability to assist with the execution of clinical trials, per protocol. This includes developing and completing source documents and case report forms (CRFs), online data entry into Electronic Data Capture (EDC) sites, reviewing subject diaries (when applicable), developing and administering informed consent forms, following study subjects from the beginning to the end of each trial or until the subject withdraws informed consent, and monitoring study subjects as appropriate.
2. Assure compliance with the protocol requirements as mandated by the sponsor, Standard Operating Procedures (SOPs), local and/or central Institutional Review Boards (IRBs), and the FDA
3. Preparation and clean-up of study areas, preparing meals for study subjects, monitoring study subjects, charting, subject binder preparation, etc.
4. Assist in recruitment for each study, developing recruitment plans, and maintaining the clinical trial subject database.
5. General clinical tasks including: measuring vital signs such as pulse, point-of-care A1c, temperature, blood pressure, weight, height, and waist circumference, collecting and processing lab specimens, assisting with the Regulatory Binder for each study
6. Obtain certification in the following - Good Clinical Practices - NIH, Protecting Human Subjects - NIH, Human Subjects Protection - Cottage IRB, and IATA - Mayo Clinic, as well as all certified trainings required by individual study sponsors. Trainings should all be completed in a timely matter and turned in to the Clinical Research Coordinator II.
7. Perform necessary functions as described by the Principal Investigator and Clinical Research Coordinator II for the conduct of the clinical protocol, including but not limited to: assisting with oversight of bench staff operations of study-specific duties, assisting with study visits and ALCOA-compliant documentation practices, assisting with collecting, documenting, and reporting Adverse Events (AEs) and protocol deviations to relevant bodies as appropriate.
8. Maintain strict confidentiality of patients, employee, and company information at all times and in adherence to HIPAA guidelines.
9. Develop and maintain credible relationships with subjects, study staff, and sponsors.
10. Follow established policies, procedures, and objectives, quality improvement objectives, and safety, environmental, and infection control standards.
11. Other duties as assigned

QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily Training will be provided where necessary and specific assistance in refreshing the incumbent in those areas where appropriate. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Basic knowledge of office practice and office equipment
• Basic knowledge of Microsoft Office for word processing and data entry
• Excellent oral and written communication skills
• Ability to work independently and with careful attention to detail as well as in collaboration with other staff members
• Excellent multi-tasking, prioritization, and organizational skills and ability to work under stress
• Ability to transfer and record data accurately, in the required format, and in a timely manner
• Must be able to establish rapport and communicate with subjects of diverse cultural and educational backgrounds.
• Ability to handle multiple projects of different types

EDUCATION AND EXPERIENCE

• Experience working in a medical setting
• High school diploma and Bachelor's degree or equivalent experience
• Scientific education desirable

LANGUAGE SKILLS
The ability to read, write, and speak English clearly is required. The ability to interpret documents such as safety rules, SOPs, and procedures is critical and an understanding of and ability to communicate in scientific language is desired. Spanish proficiency and/or fluency desired.
PHYSICAL DEMANDS
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.
The incumbent is regularly required to sit, talk, hear, and climb stairs. The incumbent frequently is required to use hands to finger, handle or feel equipment, paper, or files. The incumbent is required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10-20 pounds. Specific vision abilities required by this job include close vision.
This position requires manual dexterity, skill level and adequate vision to record data onto data sheets and adequate hearing and verbal communication skills to converse with study subjects. Standing for extended periods of time as well as light lifting is necessary.
The incumbent must be in sufficient overall health to report for work consistently and reliably and work through a standard day with appropriate breaks.
WORK ENVIRONMENT
The work environment would be generally described as an office setting with clinical facilities adjacent to the primary work area and laboratory facilities on a different floor. The ability to move within all three of these areas may be required in the execution of the employee's functional activities. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate and the illumination of the work area is primarily with fluorescent artificial lighting.
This position is associated with exposure to biohazardous materials and communicable disease requiring the use of universal precautions at all times as well as other conditions common to a medical clinic and research facility.
This job description is intended to describe the general requirements of the performance of the job. It is not a complete list of duties, responsibilities or requirements. Other duties not listed here may be assigned as needed.