Clinical Research Associate II

About the role

Manage Clinical Studies required for the establishment of the performance of an IVD product. Authors clinical performance study monitoring plan, protocol, ICF, etc. in compliance with applicable regulations and standards. Selects, qualifies and onboards clinical study sites with the execution of study agreements and IRB approvals. Fosters effective communication and collaboration with study sites and/or CROs, and oversights the study execution from study site initiation, to site closeout. Monitors study progress, enrollment, data integrity, risk management, and ensures compliance with GCP and regulatory requirements.

Responsibilities

• Manage Clinical Studies required for the establishment of the performance of an IVD product.
• Authors clinical performance study monitoring plan, protocol, ICF, etc. in compliance with applicable regulations and standards.
• Selects, qualifies and onboards clinical study sites with the execution of study agreements and IRB approvals.
• Fosters effective communication and collaboration with study sites and/or CROs, and oversights the study execution from study site initiation, to site closeout.
• Maintains study progress, enrollment, data integrity, risk management, and ensures compliance with GCP and regulatory requirements.

Requirements

• Education: Bachelor’s degree in Life Sciences, Biomedical Sciences, or related field (advanced degree preferred).
• Work Experience: 2 years’ experience in clinical research (clinical trials execution role, preferably in an IVD, device or pharma company).
• Experiences of using eTMF and EDC platforms during clinical research.
• Deep knowledge of FDA clinical research regulations, and ICH-GCP, ISO 13485, ISO 20916.
• Excellent written and effective verbal communication skills, and people management experience.

Qualifications

• Education: Bachelor’s degree in Life Sciences, Biomedical Sciences, or related field (advanced degree preferred).
• Work Experience: 2 years’ experience in clinical research (clinical trials execution role, preferably in an IVD, device or pharma company).
• Experiences of using eTMF and EDC platforms during clinical research.
• Deep knowledge of FDA clinical research regulations, and ICH-GCP, ISO 13485, ISO 20916.
• Excellent written and effective verbal communication skills, and people management experience.

Skills

• Strong understanding of clinical research protocols and regulatory guidelines.
• Experience in managing clinical study budgets and timelines.
• Excellent communication and interpersonal skills.
• Ability to manage multiple projects simultaneously.
• Proficiency in using eTMF and EDC platforms.

Benefits

• Competitive medical plans for you and your family.
• Free HSA funds.
• New fertility offering with stipend.
• Group life and disability.
• Paid parental leave.
• 401k plus profit sharing.
• Employee stock purchase program.
• Upgraded and streamlined mental health platform.
• Extensive learning and development opportunities.
• Education benefits.
• Student debt relief program.
• Pet insurance.
• Wellness challenges and support.
• Paid time off.
• Employee Resource Groups (ERG’s).

Pay

The estimated base salary range for this position is $83,000 to $114,200 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors.

Schedule

This position must be based in Seattle, Washington and requires the employee to be located within commuting distance of the office.