What are the basic qualifications?

• 1-year of experience supporting clinical trials.

• Bachelor’s Degree in Science discipline (clinical, research or other related experience may substitute for the degree)

• Valid driver’s license/reliable daily transportation with proof of insurance.

Would you like to coordinate research studies within a Nephrology/Dialysis population through a medical clinic and dialysis center? Bring your research expertise to us and you can be proud that you are serving in an industry that helps countless people every day! This role offers an amazing team with a collaborative work environment. If you are passionate and enthusiastic about helping people, a hard worker, and have some patient facing research experience - please apply! We hire people that have a *positive team oriented approach* and genuinely love what they do. Our culture is very important to us. We want staff to enjoy their jobs, feel critical to the mission of our company, and thrive as a team.

We offer medical, dental, vision, life, disability, 401k, PTO, plus paid holidays!! This is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5:00 p.m. Hours outside of normal business hours may be required.

The CRA provides moderately complex research support following established protocols, study administration, data collection and lab support for the Research Department.

Starting pay range for this junior level position $19.00 – $25.00 per hour

Preferred Skills/Experience:

• Ability to work independently and with a team.

• Ability to work under pressure in a deadline-oriented environment.

• Enthusiastic, positive, collaborative personality who is eager to learn.

• Excellent interpersonal communication, organizational skills, and ability to problem solve, prioritize and multi-task.

• GCP and IATA knowledge.

• Overall understanding of research protocol objectives and design.

Key Responsibilities:

• Participate in the coordination of all aspects of the recruitment, enrollment, screening, marketing and follow up of study participants.

• Gather source documents and ensure complete source documentation is compiled in research record in a timely manner.

• Schedule, coordinate, prepare for and conduct sponsor monitor visits and audits in collaboration with other research team members.

• Maintain and organize all general study/potential study related documents including protocols/IRB letters/submissions, site feasibility questionnaires, sponsor letters, budgets, IB, etc.

• Ensure AE/SAE/IND safety reports are sent to PI for review in a timely fashion and update IND reports per our policies in the safety report database.

• Prepare Regulatory Binders for new studies ensuring Essential Documents are filed, including 1572, Financial Disclosure Forms, Signed/Dated CVs, IRB Approval Forms, etc.

• Performs pre-screening review of potential study subjects given criteria by the PI or Sub-I, verifying patient conformity to inclusion/exclusion criteria prior to patient enrollment in the research study.

• Collect urine and draw blood samples from each study patient in accordance with study protocol specifications and OSHA standards.

• Prepare lab shipping materials each day based upon labs to be drawn (prepare boxes for shipment, ensures refrigerated/frozen supplies are available – requires 24-hour placement of ice-pack in freezer prior to shipping).

• Assure adherence to all research standards as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), and other pertinent regulatory agencies.

Western Nephrology is a DRUG FREE WORKPLACE and an Equal Opportunity Employer. We provide equal employment opportunity to all qualified individuals regardless of race, color, religion, sex, age, national origin, citizenship, veteran status, disability, sexual orientation, gender identity, genetic information, or any other factor protected by applicable federal, state or local law.