The Clinical Research Coordinator leads and manages clinical trials in compliance with regulatory standards, working closely with the investigative team, pharmaceutical sponsors, and research participants. This role requires a strong medical background, proficiency in Good Clinical Practices (GCP), FDA regulations, and a commitment to ethical research standards.
KEY RESPONSIBILITIES:
Duties will include, but are not limited to:
- Manage and oversee the execution of clinical trials under the direction of the Principal Investigator and Site Manager.
- Conduct patient visits and ensure adherence to study protocols, collecting and processing biological specimens (blood/urine) and performing procedures such as ECGs and vital signs monitoring.
- Administer questionnaires, diaries, and other participant materials as per protocol.
- Schedule and coordinate research visits, assessments, and procedures, ensuring all requirements are met.
- Maintain accurate case report forms, cross-referencing patient medical records for completeness and FDA compliance.
- Collect, enter, and manage clinical data while maintaining confidentiality.
- Monitor study participants, ensuring adherence to study guidelines and ethical standards.
- Manage investigational medications, including receiving, dispensing, and performing drug accountability.
- Collaborate with laboratories to process, ship, and ensure review of investigational reports.
- Actively participate in recruiting and screening study participants.
- Maintain organized records of study materials, ensuring all regulatory documentation is up to date.
- Ensure necessary supplies and equipment are available and functional for each study.
- Complying with company policies, HIPAA, OSHA regulations, and Standard Operating Procedures (SOPs) to deliver high-quality services.
SKILLS & EXPERIENCE:
- Strong knowledge of medical terminology, clinical trial processes, and industry regulations.
- Excellent problem-solving, leadership, and communication skills.
- Ability to work both independently and collaboratively as part of a team.
- Proficient with computer hardware and software, including clinical research databases.
- Strong attention to detail and organizational skills.
- Ability to maintain confidentiality and handle sensitive information.
- Outstanding interpersonal skills, with the ability to establish and maintain effective relationships with patients, investigators, and external partners.
- Willingness to learn and stay updated on new clinical research trends and regulations.
ESSENTIAL FUNCTIONS:
- Ability to prioritize tasks, manage deadlines, and adapt to changing environments.
- Ability to receive and process information through both oral and written communication.
- Proficient in accessing, inputting, and retrieving data from a computer.
- Ability to sit or stand for 6-8 hours a day and lift or carry 5-10 pounds occasionally.
- Requires substantial use of wrists, hands, and fingers for tasks such as typing and filing.
