Clinical Research Assistant Ii - Santa Barbara, United States - Sansum Diabetes Research Institute

Sansum Diabetes Research Institute

Verified Company

Santa Barbara, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

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:

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
General clinical tasks including: measuring vital signs such as pulse, pointofcare A1c, temperature, blood pressure, weight, height, and waist circumference, collecting and processing lab specimens, assisting with the Regulatory Binder for each study
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.
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 studyspecific duties, assisting with study visits and ALCOAcompliant documentation practices, assisting with collecting, documenting, and reporting Adverse Events (AEs) and protocol deviations to relevant bodies as appropriate.
Maintain strict confidentiality of patients, employee, and company information at all times and in adherence to HIPAA guidelines.
Follow established policies, procedures, and objectives, quality improvement objectives, and safety, environmental, and infection control standards.
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 multitasking, 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
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.

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 essen