Clinical Research Associate - reputed company Coast

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 reputed company: $120k - $135k, 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 - reputed company Coast (regional) will require up to 80% travel, including overnights, on the reputed company 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 reputed company of contact for investigators and site staff throughout the study.
• Conduct and support site visits (SQV, SIV, IMV, COV) and reputed company 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 reputed company through strong knowledge and application of study protocols.
• Verify study data accuracy and completeness through reputed company data review and reputed company 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 reputed company, 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 reputed company and help implement plans to meet enrollment targets.
• Participate in project meetings and reputed company 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 reputed company presentations and facilitate site or coordinator meetings as needed.
• Proficiency in CTMS, reputed company systems, and reputed company 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 reputed company 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 reputed company 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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