Clinical Research Associate

About Atrium:

Client Overview:

Our client is a global pharmaceutical company that specializes in developing and manufacturing both generic and specialty drugs. They have a large portfolio spanning many therapeutic areas, including Oncology, Rare Disease, Cardio, Immunology, Nephrology, and Infectious Disease, working in phases I-IV. They are currently expanding their team and looking to add a Clinical Research Associate.

Salary/Hourly Rate:

$100k – $125k, Depending on experience 

Position Overview:

The Clinical Research Associate is responsible for monitoring and managing clinical trial activities at assigned sites to ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements. The Clinical Research Associate – West Coast (regional) will require up to 80% travel, including overnights, on the West Coast.

Responsibilities of the Clinical Research Associate:

• The Clinical Research Associate will manage and monitor clinical trial activities at assigned study sites to ensure compliance with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements.
• Serve as the primary point of contact for investigators and site staff throughout the study.
• Conduct and support site visits (SQV, SIV, IMV, COV) and perform site management activities to meet study timelines and deliverables.
• Build and maintain strong relationships with investigative sites to promote effective communication and collaboration.
• The Clinical Research Associate will ensure subject safety, protocol compliance, and data integrity through strong knowledge and application of study protocols.
• Verify study data accuracy and completeness through source data review and source data verification (SDR/SDV).
• Train and retrain site staff on protocol requirements and study procedures.
• Manage site queries, protocol deviations, and issues, escalating as appropriate.
• Ensure timely and accurate data entry and reporting of AEs, SAEs, and DS, including appropriate follow-up.
• The Clinical Research Associate will prepare and submit monitoring reports, follow-up letters, and required documentation promptly.
• Maintain accurate study files, regulatory documentation, and monitoring records, and support audits and inspections.
• Support site feasibility, patient recruitment strategies, and communication between sites and the sponsor.
• Track subject recruitment progress and help implement plans to meet enrollment targets.
• Participate in project meetings and provide updates on site status, risks, and mitigation strategies.

Required Experience/Skills for the Clinical Research Associate:

• Minimum of 5 years of onsite clinical monitoring experience.
• Strong knowledge of ICH-GCP and clinical research regulatory requirements.
• Ability to travel up to 80%, including overnight travel.
• Experience managing serious adverse events (SAEs) with safety teams and ensuring proper follow-up.
• Strong organizational, communication, and interpersonal skills.
• Ability to lead presentations and facilitate site or coordinator meetings as needed.
• Proficiency in CTMS, EDC systems, and Microsoft Office Suite.
• Strong analytical, problem-solving, and time management skills.
• Experience in fast-paced, collaborative environments.
• Experience with patient recruitment/retention strategies and site relationship management.

Preferred Experience/Skills for the Clinical Research Associate:

• Experience within Rare Disease.
• Experience collaborating with or managing CRO activities is preferred.

Education Requirements:

• Bachelor’s degree in a Life Science is required. 

Benefits:

• Competitive compensation package.
• Health, dental, and vision insurance.
• 401(k) with company matching.
• Paid time off and holidays.
• Full travel reimbursement and per diem.
• Career development and training opportunities.

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As a woman-owned firm, we value diversity. We are an equal opportunity and affirmative action employer and will consider all applications without regard to race, sex (including gender, pregnancy, sexual orientation and gender identity), age, color, religion or creed, national origin or ancestry, veteran status, disability (physical or mental), genetic information, citizenship or any other characteristic protected by law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Candidates who apply for roles through the Atrium website will be added to our candidate pool and may be considered for additional roles of a similar title. Please contact us to request an accommodation.
EOE/M/F/D/V/SO