Clinical Research Coordinator

3 days ago

Fountain Valley, California, United States DERMCARE MANAGEMENT LLC Full time $28 - $31
Job Details Job Location: First OC Dermatology (FOCD) - Dr. Laquer - Fountain Valley - Fountain Valley, CA 92708 Position Type: Full Time Education Level: High School Salary Range: $ $31.00 Hourly Travel Percentage: None Job Shift: Day Job Category: 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.

 

Qualifications

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

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