Clinical Research Coordinator

Clinical Research Coordinator - Dermatology Industry-Initiated Clinical Trials

The Clinical Research Coordinator will lead and manage clinical trials in the dermatology field, ensuring compliance with regulatory standards. The role involves close collaboration with investigative teams, pharmaceutical sponsors, and research participants, requiring a strong medical experience and proficiency in Good Clinical Practices (GCP), FDA regulations, and ethical research standards.

Responsibilities

• 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.
• Comply with company policies, HIPAA, OSHA regulations, and Standard Operating Procedures (SOPs) to deliver high-quality services.

Essential Skills

• Seasoned experience in clinical research, specifically interventional clinical trials.
• Proficiency in informed consent processes.
• Experience with IWRS and EDC systems.
• Experience in dispensing and reconciling drugs.
• Strong bedside manner and soft skills.
• Ability to take feedback, especially from direct supervisors.

Additional Skills & Qualifications

• Preferred: MA/phlebotomy skills.
• Preferred: Bilingual in either Spanish or Vietnamese.
• Nice to have: Phlebotomy certification.
• Ability to create source documents.
• Problem-solving skills.
• Basic social skills to make patients feel comfortable and confident.
• Preferred education: Bachelor's or Master's degree in a related field.
• Required: High School Diploma or GED.
• Preferred: Certification as a Clinical Research Coordinator (CCRC).

Work Environment

This position is fully on-site, operating from 8 AM to 5 PM, with a lunch break from 12 PM to 1 PM. Lunches are often catered by sponsors. The site offers easy access with a full parking lot. You will be part of a team reporting to the Director of Operations, working alongside 7-10 Clinical Research Coordinators (CRCs) and 3-4 Research Assistants (RAs). The company has been established for over 30 years and combines private practice with clinical research, handling a high volume of sponsor-initiated research studies.

Job Type & Location

This is a Contract position based out of Fountain Valley, CA.

Pay and Benefits

The pay range for this position is $28.00 - $35.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Fountain Valley, CA.