Clinical Research Coordinator
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Actalent
Fountain Valley, CA (In Person)
$70,160 Salary, Full-Time
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Job Description
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.
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). Experience Level Intermediate Level 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.
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