Clinical Research Coordinator

Clinical Research Coordinator

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.

Qualifications:

• High School Diploma or GED
• Preferred: Bachelor's or master's degree in a related field.
• Required: Previous experience conducting clinical trials, including recruitment and compliance with regulatory guidelines.
• Preferred: Certification as a Clinical Research Coordinator (CCRC).
• Phlebotomy experience and certification where required.
• Strong knowledge of medical terminology, clinical trial processes, and industry regulations.
• Proficient with computer hardware and software, including clinical research databases.
• Proficient in accessing, inputting, and retrieving data from a computer.
• Strong attention to detail and organizational skills.
• Ability to prioritize tasks, manage deadlines, and adapt to changing environments.
• Ability to receive and process information through both oral and written communication.
• Excellent problem-solving, leadership, and communication skills.
• Outstanding interpersonal skills, with the ability to establish and maintain effective relationships with patients, investigators, and external partners.
• Ability to work both independently and collaboratively as part of a team.
• Ability to maintain confidentiality and handle sensitive information.
• Willingness to learn and stay updated on new clinical research trends and regulations.
• CCRC certification a plus.
• Bi-lingual in Spanish is a plus.

Benefits:

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Supplemental health benefits
• Paid time off
• Holidays
• Retirement plan (401k)

Physical Demands and Work Environment

• 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.
• This position operates primarily in a professional office/clinical environment. The role regularly requires sitting, working at a computer, communicating with employees and managers.