Clinical Research Nurse Coordinator I

Era Health Research, LLC; Redmond (WA); Hybride; USD 62 000 - 76 000; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision insurance

401k Retirement Savings Plan

Paid time off (PTO)

Floating Holidays

Résumé du poste

ERA Health Research, LLC in Redmond, WA seeks an experienced Registered Nurse to coordinate and manage clinical trial activities in adherence to GCP and protocol requirements. The role involves patient coordination, data handling, investigational product management, and regulatory document maintenance.

Responsibilities include site initiation, informed consent, AE/SAE reporting, and collaboration across regulatory and clinical teams to ensure trial integrity and subject safety.

Qualifications

• Active, unrestricted Washington State RN license required upon hire and must be maintained throughout employment.
• At least one year clinical and/or clinical research experience
• Current CPR or Basic Life Support (BLS) certification, or the ability to obtain certification within the first 90 days of employment.
• Venipuncture and IV start skills or ability to learn within first 30 days
• Meticulous attention to detail, with ability to follow complex instructions and protocols precisely.
• Strong organizational and problem-solving skills
• Teamplayer able to effectively self-reflect, communicate, and collaborate across teams.
• Good written and verbal communication skills
• Proficient with basic computer software (MS Office)
• ERA does not provide employment visa sponsorship. Candidates must be authorized to work in the United States without employer sponsorship.

Responsabilités

• Identify objectives, endpoints and outcome measures for a given clinical trial.
• Implement protocol amendments according to GCP and verify IRB/IEC approved documents.
• Coordinate site initiation visits: schedule, documents, equipment, facilities.
• Complete training and interpret study implementation plan for tasks.
• Ensure SOPs align with study requirements.
• Identify study supplies and reconcile inventory.
• Develop trial management tools (calendar, source documents, retention materials).
• Complete pre-screening, screening and enrolment logs/forms.
• Coordinate with regulatory, recruitment, and clinical staff for patient visits.
• Complete informed consent and randomization per protocol.
• Support investigational product handling (labeling, preparation, dispensing).
• Perform nursing assessments and protocol-related procedures (vitals, ECGs, IV starts, infusions, PK sampling).
• Administer investigational products and monitor patient responses.
• Assess and report Adverse Events (AEs) and Serious Adverse Events (SAEs).
• Educate and communicate with subjects about visits, adherence, and diary completion.
• Record and report clinical data into EDC systems; handle deviations or safety issues.
• Schedule and prepare documents for monitoring visits; follow up on reports.

Connaissances

Clinical experience

Clinical research experience

Venipuncture

IV start skills

Detail oriented

Organizational skills

Team player

Written and verbal communication

MS Office proficiency

US work authorization

Formation

RN license

CPR/BLS certification

Outils

MS Office

Description du poste

DUTIES & RESPONSIBILITIES

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 enrolment 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.
• Perform nursing assessments and conduct protocol-related procedures (vitals, ECGs, IV starts, infusions, pharmacokinetic sampling, etc.).
• Administer investigational products (drugs, devices, biologics) per protocol, monitor patient responses, and provide clinical care as appropriate.
• Assess, document, and report Adverse Events (AEs) and Serious Adverse Events (SAEs) to the PI and sponsor.
• Manage, educate and communicate with subjects throughout the trial, including providing patient education and 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.
• Collect, ship, and store specimens according to requirements.
• 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 & SKILLS

Required:

• Active, unrestricted Washington State Registered Nurse (RN) license required upon hire and must be maintained throughout employment.
• At least one year clinical and/or clinical research experience
• Current CPR or Basic Life Support (BLS) certification, or the ability to obtain certification within the first 90 days of employment. Employees are responsible for obtaining and maintaining current CPR/BLS certification throughout employment
• Venipuncture and IV start skills or ability to learn within first 30 days
• Meticulous attention to detail, with ability to follow complex instructions and protocols precisely.
• Strong organizational and problem-solving skills
• Teamplayer able to effectively self-reflect, communicate, and collaborate across teams.
• Good written and verbal communication skills
• Proficient with basic computer software (MS Office)
• ERA does not provide employment visa sponsorship. Candidates must be authorized to work in the United States without employer sponsorship.

Applicants must be legally authorized to work in the United States. The company does not currently offer employment visa sponsorship, including H-1B sponsorship, for this position.

Pay and benefits

Anticipated Hiring Range: $45.00/hourly - $50.00/hourly

Full Wage Range: $45.00/hourly - $55.00/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 at10 days per year and 1 hour of sick leave for every 40 hours worked.
• 2 Floating Holidays per year

EEO STATEMENT

ERA Health Research provides equal employment opportunities to all without regard to race, color, religion, sex (including sexual orientation or gender identity), national origin, age, disability, genetic information, or other protected status. Applicants and employees with disabilities may be entitled to reasonable accommodations under the terms of the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is an adjustment to our standard application and/or interview and/or employment process which will ensure an equal employment opportunity without imposing undue hardship on ERA Health Research. Please inform our team if you are requesting accommodation to complete any forms or otherwise participate in the application process or perform the essential functions of this role.