Clinical Research Coordinator I

About the role

The Clinical Research Coordinator I coordinates all aspects of clinical trials, ensuring that trials are conducted according to ethical, regulatory, and scientific standards while maintaining participant safety and data integrity.

Responsibilities

• Identify objectives, endpoints and outcome measures for a given clinical trial.
• Implement protocol and any protocol amendments according to GCP, verifying that only IRB/IEC approved versions of study documents are being used.
• Schedule, coordinate, and prepare documents, equipment, and facilities for site initiation visits.
• Complete training and interpret a study implementation plan for relevant items that impact the tasks and activities the coordinator should prioritize for a given trial.
• Ensure consistency between the sites’ standard operating procedures (SOPs) and the study requirements.
• Identify all study supplies needed for a given clinical trial, assess and reconcile inventory to ensure adequate supplies throughout the trial.
• Develop and organize trial management tools such as subject study calendar, source documents, and retention materials to enhance subject compliance.
• Complete pre-screening, screening, and enrollment logs and forms in an accurate and timely manner.
• Coordinate with regulatory, recruitment, and clinical staff to schedule patient visits.
• Complete informed consent and randomization of subjects accurately and according to the protocol and SOPs to ensure appropriate inclusion of subjects.
• Support and manage investigational product, including labeling, preparing, and dispensing.
• Collect, ship, and store specimens according to requirements.
• Manage, educate, and communicate with subjects throughout the trial, including communicating about compliance with the visit schedule, protocol procedures, diary completion, and discontinuation.
• Complete study communications, comments, and logs in an accurate and timely manner, including basic clinical data entry into Electronic Data Capture (EDC) systems, and documenting and reporting any unanticipated problems, deviations, and/or safety-related issues following GCP.
• Schedule, coordinate, and prepare documents for monitoring visits; review monitoring visit follow-up reports/letters and perform requested post-visit activities, including resolving queries in an accurate and timely manner.
• Help with the preparation, organization, and maintenance of regulatory documents and study binders.
• Train new team members on clinical research skills to enhance competency.
• Travel to and from other company sites as needed to perform job responsibilities.
• Perform other tasks or projects as assigned by a supervisor or manager, within the scope of the role.

Requirements

• 1-2 years of Clinical Research Experience
• Basic understanding of scientific and medical terminology
• Meticulous attention to detail, with ability to follow complex instructions and protocols precisely
• Strong organizational and problem-solving skills
• Team player able to effectively self-reflect, communicate, and collaborate across teams
• Good written and verbal communication skills
• Ability to obtain and maintain an active, unrestricted Washington State Medical Assistant-Registered (MA-R) AND Medical Assistant-Phlebotomist (MA-P) credentials (ERA will assist with obtaining initial credentials and cover initial and renewal credentialing fees; employees are responsible for maintaining active credentials throughout employment)
• Current Basic Life Support (BLS) certification is not required at the time of hire but must be obtained within the first 90 days of employment (employer will pay the initial certification fee; employees are responsible for maintaining current BLS certification throughout employment)
• Proficient with basic computer software (MS Office)

Pay

Pay Range: $30.00/hourly - $32.50/hourly. Pay is based upon candidate experience and qualifications, as well as market and business considerations.

Benefits

• Medical, dental, and vision insurance
• Flexible Spending Account (FSA) and Health Savings Account (HSA) options
• 401k Retirement Savings Plan
• Paid time off (PTO) starting at 10 days per year and 1 hour of sick leave for every 40 hours worked
• 2 Floating Holidays per year