Clinical Research Coordinator

Seattle Clinical Research Center is seeking a full-time Clinical Research Coordinator to join our research team.

Seattle Clinical Research Center (SCRC) is a dedicated clinical trial investigative site. SCRC has successfully executed hundreds of multi-specialty Phase I-IV medical device and biopharma clinical trials since 1991 and has particular expertise in women’s health-related drugs and medical devices as well as dermatology, endocrinology and vaccine studies.

The Clinical Research Coordinator (CRC) serves as an integral member of the research team and will work closely with members of SCRC's staff across the organization. The ideal candidate will combine clinical research experience with excellent communication skills and the ability to manage multiple projects with strong attention to detail. The CRC’s main responsibility is the conduct of multiple clinical trials. CRC’s will work closely with research subjects, the Principal Investigator, Sub-Investigators, and Sponsors/CROs to ensure that each study is conducted properly per protocol and Good Clinical Practice.

There is little to no room for remote work in this position.

Job Responsibilities:

• Obtain subject medical history and medication information, review study inclusion/exclusion criteria, confirm eligibility to participate in study with investigator.
• Perform consent discussion and ensure proper documentation.
• Recruit/screen potential study subjects – ensure goals/deadlines are being upheld.
• Schedule and conduct subject visits.
• Collaborate with staff to ensure tests and procedures required per protocol are performed and documented (e.g., EKG, phlebotomy, vitals, specimen processing, other specific procedures).
• Tracking clinical trial subjects and scheduling follow-up assessments.
• Completing and organizing regulatory documents.
• Perform regulatory activities as assigned, which may include but are not limited to: preparation and submission of IRB documents, maintenance of essential regulatory documents, sponsor/CRO regulatory communications, deviation reporting, and regulatory binder management.
• Communicating with the Sponsor, CRO, & IRB.
• Performing all coordinator-mediated tasks, per individual protocols.
• Study drug dispensing/administration/accountability.
• Processing and packaging specimens, per IATA guidelines
• Meet and communicate with sponsors, prepare for monitoring visits.
• Maintain detailed study records in compliance with study protocol, FDA, IRB, ICH, etc.

In order to be successful at this position, you should:

• Have at least one year of experience as a Clinical Research Coordinator (CRC)
• Have experience with direct patient care
• Have experience in conducting an informed consent discussion
• Have experience obtaining medical history and basic vital signs
• Demonstrate working knowledge of clinical research regulatory requirements, including ICH-GCP, FDA regulations and IRB processes.
• Be organized, flexible, and willing to step in where needed
• Have a high attention to detail
• Adhere to SCRC’s core values: Compassionate Care, Passion to Excel, Trust, Respect, and Collaborative Spirit

Preferred requirements:

• Have a Bachelor's degree
• Phlebotomy experience
• Processing and packaging lab specimens in compliance with IATA guidelines
• Training in HIPAA, Good Clinical Practices (GCP) and Human Research Protection
• Prior experience with regulatory document preparation, submission and maintenance.

Job Type: Full-time

Pay: $28.85 - $41.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Vision insurance
• Subsidized Transit Pass (ORCA)