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Clinical Research Project Manager
2 months ago
Salary: Competitive
Summary:
As a Clinical Research Project Manager, you excel in multitasking, prioritizing, and ensuring efficiency in all your tasks. Your keen attention to detail makes you the go-to person for your colleagues when they need assistance with their work. You have a passion for analyzing and understanding extensive information. When challenges arise, you leverage your experience and tools to implement effective solutions. You are committed to following protocols while remaining adaptable to changing circumstances. As the leader of your projects, you set your own timelines and consistently meet them. Providing excellent patient care and maintaining a compassionate bedside manner are paramount to you. In your spare time, you enjoy reading, completing tasks, and engaging in creative endeavors. You are open to innovative thinking and stepping outside your comfort zone. Your goal as a Clinical Research Project Manager is to enhance your skills and advance your career in a patient-centered environment, reflecting your dedication to the community you serve. A minimum of one year of clinical research experience is required, along with a Bachelor's degree.
Key Responsibilities:
- Coordinate patient appointments, independently managing complex interventional and therapeutic protocols in accordance with FDA regulations and ICH-GCP guidelines across multiple locations.
- Drive patient recruitment efforts to achieve enrollment targets for assigned studies through chart reviews, educational sessions, and community outreach initiatives.
- Foster strong relationships with stakeholders, including sponsors, CROs, and physician specialists.
- Ensure compliance with safety protocols by identifying, documenting, and reporting adverse events and protocol deviations, while collaborating with the Principal Investigator and patients to evaluate eligibility for trials.
- Maintain comprehensive records related to drug handling, including receipt, dispensing, and patient education on study compliance.
- Obtain necessary training and certifications to conduct various assessments and examinations as outlined in study protocols.
- Process and disseminate critical study information by reviewing bulletins, newsletters, and memos, updating documents, and communicating with the team via project management tools.
- Collect patient vitals, perform phlebotomy, and manage laboratory sample processing and shipping.
Qualifications:
- A minimum of one year of clinical research experience, with familiarity in key terminology such as EDC, GCP, ICF, SIV/IMV/COV, AE/SAE, and DOA.
- Experience in reviewing patient charts for trial eligibility and a proactive approach to patient communication.
- Proven time management skills to handle multiple responsibilities effectively, ensuring deadlines are met.
- Prior experience or a strong interest in ophthalmology is advantageous.
Learning Opportunities:
- As the lead on assigned studies, you will gain expertise in timely study initiation, source document development, and management of monitoring visits.
- Learn to conduct quality assurance checks and audit patient source and regulatory files.
- Engage in regulatory tasks, including file maintenance, document execution, and adherence to IRB reporting guidelines.
Team Structure:
This position reports directly to the Director of Clinical Research.
Benefits:
- Competitive salary
- Health insurance
- Dental and vision coverage
- Paid time off
- Bonus structure
- Retirement plan
- Flexible work schedule
- Company-sponsored events
Company Values:
- Align daily priorities with organizational goals
- Provide exceptional service to all stakeholders
- Commit to continuous learning
- Arrive prepared and ready to contribute
- Embrace collaboration and communication
- Maintain a positive and purposeful approach
About DocTrials:
DocTrials is dedicated to fostering a culture of care and collaboration among our team, clients, and the communities we serve. Our organization consists of physician sites that specialize in conducting clinical studies within their practices, adhering to rigorous standard operating procedures and quality control measures. This commitment ensures the highest quality data collection and best practices across all sites, providing confidence to sponsors in achieving reliable results efficiently. Our mission is to connect patients and physicians with clinical trials throughout the United States, facilitating the discovery of new therapies and treatments for various diseases.