Clinical Research Coordinator I

Job Description

Job Description

ERA Health Research is seeking a full-time Clinical Research Coordinator I to join our Clinical Operations team in Redmond, WA. 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.

DUTIES & 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, 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.
• In addition to the specific responsibilities outlined above, this role may perform other tasks or projects as assigned by a supervisor or manager. These additional duties will fall within the scope of the role and contribute to the overall success of the team.

QUALIFICATIONS

Required:

• 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 Medicals Assistant-Phlebotomist (MA-P) credentials. ERA will assist the selected candidate with obtaining the initial credentials and will 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. Candidates who already hold a current BLS certification may provide documentation upon hire Employees without current BLS certification must obtain certification within the first 90 days of employment. The employer will pay the initial certification fee, and employees are responsible for maintaining current BLS certification throughout employment
• Proficient with basic computer software (MS Office)

Pay & benefits

Pay Range: $30.00/hourly - $32.50/hourly

Pay is based upon candidate experience and qualifications, as well as market and business considerations

ERA Health Research provides eligible employees with an opportunity to enroll in a comprehensive benefits package which includes:

• 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