Clinical Research Coordinator (FOCD-Research)

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.
•    Phlebotomy experience and certification where required.
•    CCRC certification a plus .
•    Bi-lingual in Spanish is a plus.

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.
 

EDUCATION REQUIREMENTS:

•    High School Diploma or GED 
•    Preferred: Bachelor’s or Master’s degree in a related field.

EXPERIENCE:

•    Required: Previous experience conducting clinical trials, including recruitment and compliance with regulatory guidelines.
•    Preferred: Certification as a Clinical Research Coordinator (CCRC).

Wage Range: $28.00/hr to $31.00/hr DOE

Salary : $28 - $31