Clinical Research Coordinator

Seattle Clinical Research Center is hiring a Clinical Research Coordinator to conduct multiple clinical trials and coordinate with research subjects, investigators, sponsors, and CROs. The role ensures studies are conducted according to protocol and Good Clinical Practice, including subject visits, regulatory activities, study documentation, and specimen handling.

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

Preferred

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

Bachelor’s Degree

Phlebotomy

Laboratory Specimen Processing

Specimen Packaging

IATA Guidelines

HIPAA

Clinical Practices (GCP)

Human Research Protection

Regulatory Document Preparation

Regulatory Submissions

Regulatory Document Maintenance

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)

Company

Clinical trial site for women's health and biopharma studies.

Seattle, Washington, USA

https://seattlecrc.com/

Founded in 1991

11-50 employees

Qualifications

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

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

Required skills

Clinical Research Coordination, Direct Patient Care, Informed Consent, Medical History Collection, Vital Signs Measurement, ICH-GCP, FDA Regulations, IRB Processes, Phlebotomy, IATA Specimen Processing and Packaging, HIPAA, Human Research Protection, Regulatory Document Preparation and Maintenance

Preferred skills

Have a Bachelor's degree, Phlebotomy experience

Experience

1+ years