Senior Clinical Research Associate

PharmaIN, Corp.; Bothell (WA); Hybrid; USD 130,000 - 150,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Health Savings Account

401(k) plan and financial planning

Equity Incentive Plan

Life and AD&D insurance

Paid time off and holidays

Parental leave

Employee assistance program

Dynamic work environment

Job summary

PharmaIN Corporation in Bothell, WA, is seeking an experienced Senior Clinical Research Associate (Sr. CRA) to join our Clinical Operations team for Phase 1–3 studies in oncology and liver disease.

This hybrid, in-house sponsor-side role involves site management, CRO oversight, study start-up through close-out, and mentorship of junior staff.

Candidates should have 4+ years of CRA experience, strong ICH-GCP knowledge, and the ability to work cross-functionally in a fast-paced biotech environment.

Qualifications

• Bachelor’s degree in a scientific, healthcare, or related field or equivalent experience.
• 4+ years CRA/clinical research experience including sponsor-side monitoring.
• Experience with Phase 1–3 trials and site management.
• Strong knowledge of ICH-GCP and applicable clinical research regulations.

Responsibilities

• Support clinical study execution from start-up through close-out in compliance with ICH-GCP and study protocols.
• Provide oversight of investigative sites, CROs, and vendors.
• Track study timelines, enrollment, site performance, monitoring activities, data quality, and operational metrics.
• Identify and communicate study risks and mitigations.
• Oversee site identification, feasibility, activation, and ongoing site management.
• Review essential start-up documentation and ensure site readiness for activation.
• Maintain communication with investigative sites and address issues.
• Conduct sponsor oversight visits and co-monitoring visits as needed.
• Support CRO and vendor selection and oversee performance and deliverables.
• Review monitoring reports and address significant findings.

Skills

CRA/clinical research experience

Sponsor-side experience

Phase 1–3 trials

ICH-GCP knowledge

Cross-functional collaboration

Education

Bachelor’s degree in science/healthcare

Tools

CTMS

eTMF

EDC

IRT

eCOA

Job description

Senior Clinical Research Associate (Sr. CRA) | Clinical Operations

Location: Bothell, WA | Hybrid, Greater Seattle Area

Position Type: Full-Time, Exempt

Department: Clinical Operations

Reports to: VP, Clinical Operations

Biotech | Clinical Trials | Phase 1–3 | GCP | Oncology & Liver Disease

About PharmaIN

PharmaIN Corporation is a clinical-stage biopharmaceutical company dedicated to developing first- and best-in-class subcutaneous therapies through our proprietary peptide engineering platform. By combining expertise in target-specific biology, peptide drug design, and innovative drug delivery, PharmaIN is advancing novel therapies for patients with advanced cirrhosis and cancer.

Join a growing team committed to developing transformational therapies for patients with significant unmet medical needs. At PharmaIN, we value teamwork, collaboration, mutual respect, and the contributions of every team member. Learn more at www.pharmain.com

About the Role

We are looking for an experienced Senior Clinical Research Associate (Sr. CRA) to join our Clinical Operations team and play an important role in the execution and oversight of PharmaIN's clinical studies.

This is a hybrid, in-house, sponsor-side position for a collaborative, hands-on clinical research professional who thrives in a growing, fast-paced biotechnology environment. You will work closely with the Clinical Trial Manager, cross-functional team members, CROs, vendors, and investigative sites to support Phase 1–3 clinical trials in liver disease and oncology, from study start-up through closeout.

The Sr. CRA will provide site management and sponsor oversight of CRO and vendor activities, proactively identify and resolve operational issues, and help ensure studies are conducted with high quality, in compliance with applicable requirements, and according to study timelines.

This is not a traditional Field CRA position. However, the Sr. CRA will have direct engagement with investigative sites and may conduct sponsor oversight, site qualification, initiation, and co-monitoring visits as needed.

The ideal candidate is a highly motivated, detail-oriented professional who takes ownership, communicates effectively, and builds strong relationships with internal and external partners. You should be comfortable working independently, managing multiple priorities, and collaborating across functions to move clinical studies forward.

This position reports to the Vice President, Clinical Operations and may provide mentorship and training to CRAs and Clinical Trial Assistants (CTAs).

Key Responsibilities

• Support clinical study execution from start-up through close-out in compliance with ICH-GCP, applicable regulations, PharmaIN SOPs, and study protocols.
• Manage assigned study activities and provide oversight of investigative sites, CROs, and vendors.
• Track study timelines, enrollment, site performance, monitoring activities, data quality, and key operational metrics.
• Proactively identify, communicate, and elevate study risks and contribute to development and implementation of mitigation plans.
• Contribute to the development and review of protocols, informed consent forms (ICFs), CRFs, study plans, monitoring tools, and other study documents.
• Support site identification, feasibility, selection, activation, and ongoing site management.
• Review essential start-up documentation and help ensure site readiness for activation.
• Maintain direct communication with investigative sites and facilitate timely resolution of operational issues.
• Conduct sponsor oversight visits and as needed, site qualification, initiation, and co-monitoring visits.
• Support CRO and vendor selection and provide ongoing oversight of performance, quality, timelines, and deliverables.
• Review Field CRA monitoring reports and follow up on significant findings, trends, action items, and site-level issues.
• Support oversight and maintenance of the Trial Master File (TMF) and ongoing inspection readiness.
• Collaborate with Data Management to support timely, high-quality clinical data and query resolution.
• Coordinate with Clinical Supply, CMC, laboratories, and other vendors to support investigational product, laboratory supplies, and biological sample logistics.
• Support IRB/IEC and regulatory activities, safety reviews, and other cross-functional study activities.
• Mentor junior team members and contribute to Clinical Operations process improvements, SOPs, tools, and templates.

Qualifications

• Bachelor's degree in a scientific, healthcare, or related field; nursing degree; or equivalent relevant experience.
• 4+ years of CRA/clinical research experience, including Field CRA monitoring experience within a pharmaceutical, biotechnology, or CRO environment.
• Sponsor-side clinical trial experience preferred.
• Experience with site-level clinical trial management and CRO/vendor oversight.
• Experience supporting Phase 1 through Phase 3 clinical trials; multinational clinical trial experience is a plus.
• Strong working knowledge of ICH-GCP and applicable clinical research regulations.
• Experience in oncology, immuno-oncology, hematology, or liver disease preferred.
• Familiarity with clinical systems, including CTMS, eTMF, EDC, IRT, and eCOA.
• Strong organizational, analytical, problem-solving, and written and verbal communication skills.
• Ability to manage multiple priorities and work effectively across cross-functional teams in a fast-paced environment.
• Proficiency with Microsoft Office; experience with Smartsheet or Microsoft Project is a plus.

Travel & Work Requirements

• Hybrid, in-house sponsor-side position based in Bothell, WA, with an in-office component and travel to investigative sites and other study-related locations as needed.
• Up to 30% domestic travel, with limited international travel possible.
• Occasional evening or weekend availability may be required to support time-sensitive study activities, including participant Day 1 dosing, investigator meetings, or conferences.

PharmaIN is committed to fair and equitable compensation. The anticipated base salary range for this position is $130,000 to $150,000 annually. Actual compensation will be determined based on factors including work location, relevant experience, skills, education and training, and market considerations.

Base salary is one component of PharmaIN's overall compensation package. Eligible employees may also participate in the company's benefits and equity programs, which include:

• Medical, dental, and vision insurance
• Health Savings Account
• 401(k) plan and financial planning services
• Equity Incentive Plan participation, including stock options
• Life and AD&DD insurance
• Paid time off and company-observed holidays
• Parental leave
• Employee assistance program
• A dynamic work environment that supports professional growth and development

Additional details regarding eligibility and participation will be provided as part of the employment offer. PharmaIN's compensation and benefits programs are subject to applicable plan terms and eligibility requirements.

Why PharmaIN?

At PharmaIN, we believe our employees are our greatest asset. We foster a collaborative and inclusive environment where team members are encouraged to contribute their perspectives, take ownership of their work, and grow professionally.

If you are an experienced CRA who wants to move beyond a traditional field-monitoring role and contribute more broadly to sponsor-side clinical trial execution, site management, and CRO/vendor oversight, we would love to hear from you.

PharmaIN is committed to building a diverse, high-performing workforce and providing equal employment opportunities to employees and applicants. PharmaIN prohibits discrimination and harassment based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other characteristic protected by applicable federal, state, or local law.

Additional Information

This job description is intended to describe the general nature and level of work performed in this position and is not intended to be an exhaustive list of all duties, responsibilities, or qualifications.

Job Type: Full-time

Pay range: $130,000 to $150,000 per year

Work Environment: Hybrid, with an in-office component and travel to clinical sites and other study-related locations as needed