Senior Clinical Research Coordinator

Gastro Health•Olympia, WA

About The Position

Gastro Health, LLC is a leading medical group made up of physicians and advanced practitioners specializing in the treatment of gastrointestinal disorders, nutrition, and digestive health. Our research division provides patient access to Phase I-IV clinical research initiatives relational to Gastroenterology and Hepatology throughout the world. Our mission is to provide outstanding medical care and an exceptional healthcare experience. Gastro Health is built on our Core Values of Compassion, Collaboration, Integrity, Empowerment, Accountability, Continuous Improvement, and Positive Attitude. Job Summary: Due to our rapid growth, we are currently seeking an industry professional to join our research team. This vital role will work directly with subjects, under the direct supervision of the Principal Investigator (PI). This role will be responsible for performing and implementing all aspects of clinical research trials, ensuring protocol-specific and regulatory compliance.

Requirements

Minimum of 2 years of clinical research experience required
Bachelor's Degree, preferred
Availability to travel as required for training sessions
Phlebotomy/Venipuncture experience preferred
Prior knowledge of clinical trials, as well as ICH-GCP principles, preferred
Self-starter capable of working independently
Ability to thrive in a fast-paced, high-pressure environment
Desire to train and develop skills
Exceptional written and oral communication skills
BLS certification, preferred
Familiarity with medical terminology
Knowledge of how to operate/conduct and ECG/EKG Machine
Ability to provide shadow support to entry-level research personnel
Certification via SOCRA and/or ACRP
Knowledge of Protocol Deviations, Serious Adverse Events, and Safety Reports
1-2 years of experience utilizing a CTMS, EDC, IWRS/IXRS, EHR (AllScripts)
Strong communication skills

Responsibilities

Coordinate and participate in site preparation for Site Initiation Visits, interim Monitoring Visits, Investigator Meetings, and Close-Out visits
Ensure the safety and well-being of all study-related subjects throughout the course of their study participation
Work closely with the PI to ensure compliance with protocols, and successfully conduct all assigned study-related activities in accordance with FDA and ICH GCP guidelines
Ensure Standard Operating Procedures are enforced and followed with strict adherence to company policy
Assure IRB approvals are obtained prior to initiating any study-related activities
Recruit and track subjects with expectations for target enrollment goals
Current proficiency with conducting phlebotomy
Consent subjects in accordance with FDA, GCP and protocol guidelines
Ensure adequate understanding of inclusion and exclusion criteria for each protocol
Accurately record and communicate all adverse events (AEs) to the PI and monitor in a timely manner
Record all concomitant medications and medical/surgical history accurately for each subject
Schedule all subject visits within study timelines identified within the protocols
Ensure subject safety and communicate safety data in a timely manner with the PI
Collect and accurately record study data in source documents and case report forms
Design and maintain organizational tools to conduct study activity accurately and in compliance with GCP, FDA and protocol guidelines
Complete all paperwork as required by sponsor and CRA in a timely manner
Facilitation of Close-Out, Site Initiation, and Monitoring visits as required/needed

Benefits

Health
Dental
Vision
Paid Time Off
Life insurance
401k
Profit Sharing Plan
Short & Long-term disability
HSA
FSA
Corporate Holidays
Medical
Dental
Vision
Spending Accounts
Life / AD&D
Disability
Accident
Critical Illness
Hospital Indemnity
Legal
Identity Theft
Pet
401(k) retirement plan with Non-Elective Safe Harbor employer contribution for eligible employees
Discretionary profit-sharing with employer contributions of 0% - 4% for eligible employees