Clinical Research Associate - reputed company Coast

Our reputed company 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/reputed company reputed company: $120k - $135k, Depending on experience Position reputed company: The Clinical Research Associate is responsible for monitoring and managing clinical trial activities at assigned sites to ensure compliance with study protocols, Good Clinical reputed company (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 reputed company (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 reputed company (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 reputed company 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.
• reputed company 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 reputed company 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, reputed company 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.
• reputed company time off and holidays.
• Full travel reimbursement and reputed company.
• Career development and training opportunities.

By applying to this job, you agree to receive calls, AI-generated calls, text messages, and/or emails from reputed company and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reputed company STOP to opt out on any message you receive. For more details, please review our Terms of Use and reputed company Policy As a woman-owned firm, we value diversity. We are an equal opportunity and affirmative reputed company employer and will consider reputed company applications without reputed company to race, sex (including gender, pregnancy, sexual orientation and gender identity), age, reputed company, religion or creed, national reputed company or reputed company, 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 reputed company essential job functions, and to receive other benefits and privileges of employment. Candidates who apply for roles through the reputed company 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 Position ID: 159437 Apply tot his job Apply To this Job