Clinical Research Ambassador - Volunteer

In close collaboration with the Clinical Research Assistants, Coordinators, and Principal Investigator, the incumbent will support 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.

This is a volunteer position however work hours will need to be flexible to meet individual study needs. Evening, weekend, and overnight work may be requested. This is a fully in-person position and consistent attendance is required. 

This position will fulfill the following specific functions:

1. Serve as support staff on projects as assigned
2. Preparation and clean-up of study areas, preparing meals for study subjects, monitoring study subjects, charting, subject binder preparation, etc.
3. General Clinical tasks including but not limited to: measuring vital signs such as pulse, point of care A1c, temperature, fingerstick blood glucose, blood pressure, weight, height, and waist circumference, collecting and processing lab specimens, preparing treatment rooms, assisting with the Regulatory Binder.
4. General Office tasks including document management and data entry.
5. Work closely with the Clinical Research Coordinator and the Principal Investigator to become thoroughly familiar and assist with the execution of the clinical trial, per protocol. This includes completing source documents, completing case report forms (CRFs).
6. Obtain certification in the following: Good Clinical Practices - NIH, Protecting Human Subjects – NIH, Human Subjects Protection – Cottage IRB, and IATA – Mayo Clinic, and all certified trainings required by the sponsor. All trainings should be completed in a timely manner and turned into Clinical Research Coordinator II
7. Maintain strict confidentiality of patients, employees and company information at all times and adhere to HIPAA guidelines.
8. Develop credible relationships with subjects and both internal and external customers.
9. Follow established policies, procedures, and objectives, quality improvement objectives, and safety, environmental, and/or infection control standard.

QUALIFICATIONS

The incumbent 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 accepted clinical research practices, including universal precautions, human subjects research protocols, and HIPAA requirements
• Knowledge of drug development process, ICH Guidelines and FDA CFRs
• Ability to work independently and with careful attention to detail as well as in collaboration with team members
• Ability to deal with problems involving several variables in standardized situation
• Ability to prioritize tasks and activities in a manner consistent with direction from supervisor
• Strong critical thinking skills
• Basic knowledge of office practices and office equipment.
• Basic knowledge of computer systems for word processing, electronic mail, data entry, and electronic data transfer
• Basic keyboarding skills.
• Excellent communication skills both oral and written
• Strong interpersonal skills and ability to communicate with all staff members
• Must be able to establish rapport and communicate with clients of diverse cultural and educational backgrounds.

EDUCATION AND EXPERIENCE

• High school diploma and minimum 2 years of college
• Scientific education desirable
• Experience working in medical settings desirable

LANGUAGE SKILLS

The ability to read and speak English clearly is required. Spanish proficiency and/or fluency desired. The ability to interpret oral, written, and diagram-form documents such as safety rules, operating/maintenance instructions and procedure manuals is critical. The ability to communicate information to other employees as well as management in a clear and concise manner is essential. 

PHYSICAL DEMANDS

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 must be able to operate a computer keyboard as well as see a computer monitor display screen. The incumbent is occasionally 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 the manual dexterity, skill level and adequate vision to record data onto data sheets and entering data into a computer; and adequate hearing and verbal communication skills to conduct interviews (in person or on the telephone).  Standing for extended periods of time as well as light lifting is necessary.  Substantial use of a computer.  Moderate use of the telephone.

The incumbent must be in sufficient overall health to report for work consistently and reliably and work through a standard day with appropriate breaks. Periodically, extended work hours and travel extending over several days are required.   

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.  Reliable transportation for local travel to off-site clinics will be required. Mileage costs will be reimbursed at the federal standard rate.

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.