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Clinical Trials Project Manager

2 months ago

Phoenix, Arizona, United States DocTrials Full time
Job Overview

Salary: Competitive

Summary:

As a Clinical Research Coordinator, you excel in managing multiple tasks with precision and efficiency. Your keen eye for detail makes you the go-to person for reviewing documents among your colleagues. You thrive on absorbing and analyzing extensive information, and when challenges arise, you leverage your experience to implement effective solutions. You are committed to following protocols while remaining adaptable to changing circumstances. With each assignment, you take charge as the project leader, establishing your own timelines and consistently meeting them. Prioritizing patient care and maintaining a compassionate approach is essential to you. Your interests include reading, completing tasks, and engaging in creative endeavors. You are open to innovative thinking and stepping beyond your comfort zone. In this role, you aim to enhance your skills and advance your career in a patient-centered environment, driven by a desire to contribute positively to the community. 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 by achieving enrollment targets for assigned studies through chart reviews, educational sessions, and community outreach initiatives.
  • Build and maintain strong relationships with stakeholders, including sponsors, CROs, and physician specialists.
  • Ensure adherence to safety protocols by identifying, documenting, and reporting adverse events and protocol deviations, while collaborating with the Principal Investigator and patients to assess eligibility throughout the trial.
  • Maintain comprehensive records of drug receipt, dispensing, and management, including patient education and adherence monitoring.
  • Obtain necessary training and certifications to perform various assessments and examinations as outlined in study protocols.
  • Process critical study information by reviewing bulletins, newsletters, and memos, updating documents, and communicating changes to 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.
  • Strong time management skills to effectively handle multiple responsibilities and meet deadlines.
  • Previous experience or interest in ophthalmology is a significant advantage.

Learning Opportunities:

  • As the lead project manager for assigned studies, you will gain experience in executing timely study start-up, developing source documents, and managing 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 Offered:

  • Competitive salary
  • Health insurance
  • Dental and vision coverage
  • Paid time off
  • Bonus structure
  • Retirement plan
  • Flexible work schedule
  • Company-sponsored activities

Core Values:

  • Align daily priorities with organizational goals
  • Provide exceptional service to all stakeholders
  • Commit to continuous learning and improvement
  • Arrive prepared and ready to contribute
  • Foster a collaborative environment
  • Embrace adaptability and resilience
  • Recognize the complexities in decision-making
  • Act with purpose and integrity

About DocTrials:

DocTrials is dedicated to fostering a culture rooted in our core values and behaviors. Our success hinges on our commitment to each other, our clients, and the communities we serve. We are a network of physician sites specializing in conducting clinical studies within private practices, adhering to stringent standard operating procedures and quality control measures. This approach ensures that sponsors receive high-quality data efficiently and effectively. Our mission is to connect patients and physicians with clinical trials across the nation, facilitating the discovery of new therapies and offering hope for improved treatments.