CLINICAL RESEARCH COORDINATOR: Immediate full time job opening for a large multi-specialty research center specializing in metabolic disorders. We conduct research studies of investigational medications and devices for pharmaceutical and biotech companies with an emphasis in diabetes, lipids and obesity.

The Clinical Research Coordinator, under the supervision of the Principal Investigator, executes and coordinates daily clinical research activities and performs necessary functions for the conduct of clinical studies according to ICH/GCP guidelines and FDA regulations

Responsibilities :

• Performing study related procedures including but not limited to:
• Consenting patients
• Taking EKG's and vital signs
• Completing all study-related documents in a timely manner
• Ensure Patient Compliance to Protocol
• Ensure that GCP and FDA guidelines are followed
• Work with sponsoring pharmaceutical company to ensure that all required duties are completed
• Dispense and account for investigational drug and/or devices

Requirements:

• Must be willing to work onsite at our office in Renton, WA
• Must have excellent communication skills
• Must have work experience as a Clinical Research Coordinator
• Must have patient care experience
• Must have flexible schedule and able to work occasional after hours shifts
• Must be highly organized with great attention to detail
• Must thrive in a fast-paced environment and be able to multi-task
• Must be highly self-motivated
• Bachelor's Degree in Science or Nursing
• Phlebotomy/IV skills preferred
• Medical Assistant skills preferred

Experience with diabetes or diabetes education preferred

1. Study Start-up

· Attend Investigator Meetings

· Work with recruitment team to develop a recruiting strategy

· Develop source documents according to SOPs

· Obtain proper training on study specific procedures and documents

· Ensure staff completion of proper training on study specific procedures and documents

Become thoroughly knowledgeable with assigned protocols

a. Inclusion/Exclusion criteria

b. Allowed/disallowed medications

c. Procedure requirements (Labs, ECGs, etc)

d. Patient visit requirements

e. Proper medication dispensing and titrations

2. Manage All Aspects of Conducting Clinical Trial

· Properly consent the patients

· Certify that all study related procedures are done according to protocol

· Ensure that Case Report Forms (CRFs) and other documentation are done according to protocol

· Confirm that Investigational product is dispensed and returned properly

· Verify patient compliance to protocol

· Work with Clinical Research Associate (CRA)/Monitor to resolve queries and corrections

· Function as a liaison between patient, RCRC, Investigator, and sponsor

· Follow Good Clinical Practices Guidelines

· Work closely with Investigators to ensure patient safety and compliance

· Coordinator understands and comply FDA regulations and able apply those effectively

· Coordinator shows a basic sense of responsibility for their studies.

· Disclaimer: May be asked to do other not listed tasks as well.

· Able to manage higher level studies requiring more advance interaction with patient and physician for example insulin titration.

· Able to develop and lead a team to optimize coordination with their studies.

4. Study Completion

· Ensure that all data is submitted to the sponsor

· Work with CRA/Monitor to resolve outstanding issues

Job Type: Full-time

Required experience: Clinical Research Coordinator work experience required

Benefits:

• Medical insurance
• Dental insurance
• Vision insurance
• Flexible Spending Account
• Health Savings Account
• Employee Assistance Program
• Adoption assistance
• 401(k)
• 401(k) matching after 1,000 hours worked
• PTO - Accrue 5 hours per pay period = 120 hours
• 7 paid holidays observed - New Year's Day, Memorial Day, 4th of July, Labor Day, Thanksgiving Day, Day after Thanksgiving, Christmas Day
• 2 paid floating holidays

Company Education Allowance:

• Education Grant - Employees are eligible for a $200 education grant after one year of employment to be used for professional development or continuing education courses related to medical or research activities.
• Tuition reimbursement - Employees who have worked for the Company for a minimum of two years will be eligible for tuition reimbursement of 50% of the cost of tuition up to a maximum of $1500 per year to be reimbursed for professional development programs or courses related to medical or research activities. to receive the education allowance.
• Educational Reimbursement for Professional Employees (MD, ARNP, RN, or RD). Professional employees who are required to complete a certain number of educational hours to maintain their licensure will be reimbursed to the limits specified in the Company Educational Allowance. The licensure that is being maintained must be a credential that is utilized for employment with the Company such as a MD, ARNP, RN or RD license.

Job Type: Full-time

• Bonus pay

Medical specialties:

• Diabetes

Schedule:

• 8 hour shift
• 10 hour shift
• Day shift
• Monday - Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Renton, WA 98057: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Shift availability:

• Day Shift (Required)

Work Location: One location, on-site at our clinic.

Job Type: Full-time

Pay: $67,725.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Tuition reimbursement
• Vision insurance

Medical Specialty:

• Endocrinology
• Infectious Disease

Schedule:

• 10 hour shift
• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Clinical trials: 1 year (Required)
• Clinical research: 1 year (Required)

Ability to Relocate:

• Renton, WA 98057: Relocate before starting work (Required)

Work Location: In person