Clinical Research Coordinator II

Responsibilities

• Manages multiple clinical trial protocols, coordinates execution and follow-up, and performs accurate documentation.
• Promotes Principal Investigator oversight by advising on deviations, patient status, and trial integrity issues.
• Detail oriented and has teamwork skills; motivated, organized, ability to perform multiple tasks in a timely manner, and work efficiently under pressure.
• Simultaneously executes and coordinates multiple clinical trials and functions independently; performs diverse clinical and clerical duties.
• Other duties as assigned.
• Reviews informed consent documents with study candidates and ensures patient advocacy and informed consent throughout the trial.
• Coordinates support staff, laboratory technicians, and assistants to ensure efficient and high-quality results.
• Serves as a liaison between Principal Investigators, the Institutional Review Board, and the Office of Sponsored Programs.
• Prepares and reviews documentation for clinical research study start-up, execution, modification, renewal, and termination.
• Maintains current knowledge of regulatory requirements and implements changes as needed.
• Collaborates with study sponsors and assists site monitors during visits.
• Works flexible hours and is available for research project-related questions.
• Communicates effectively with healthcare team members, patients, investigators, sponsors, and administration.
• Manages records, study medication, and test articles confidentially and securely.

Requirements

• Ability to work independently in a fast-paced clinical or research environment.
• Interpersonal communication skills; ability to interact and maintain good relationships with a broad spectrum of healthcare disciplines and the public under all circumstances.
• Detail-oriented with teamwork skills; motivated, organized, and capable of performing multiple tasks in a timely manner, and working efficiently under pressure.
• Ability to simultaneously execute and coordinate multiple clinical trials and function independently; perform diverse clinical and clerical duties.
• Specialized knowledge of the unique needs of patients undergoing treatment in research trials including device management trials.
• Critical thinker with an analytical approach to problem-solving.
• Minimum of two to five years leveraging knowledge of human life sciences/biomedical research; physiological, cellular, biochemical, or molecular biology.
• Minimum two to five years understanding and leveraging standard clinical practices with regard to informed consent, biospecimen collection, and handling.
• Working knowledge of Microsoft Office applications, such as Word, Excel, Access, Outlook, and Internet knowledge and skill.
• Demonstrated proficiency in clinical study coordination across a spectrum of trial acuities.
• Knowledge of Federal regulations: Food and Drug Administration (FDA), Centers for Disease Control (CDC), Department of Health and Human Services (DHHS).
• Bilingual (English/Spanish) [Preferred].

Qualifications

• Education: Bachelor's [Required].
• Work Experience: 2+ years in clinical research [Required].
• Cardiology experience [Preferred].
• Research experience including awareness of FDA / OHRP / ICH / GCP Guidelines and relevant state and federal regulatory/statutory guidelines [Required].
• An equivalent combination of education and relevant work experience may be considered in lieu of the stated degree requirement:
  • Bachelor's degree and 2+ years of experience,
  • Associate's degree and 4+ years of experience,
  • Technical/Vocational School and 6+ years of clinical research experience.
• Other certification as applicable to degree or program (e.g., medical assistant, medical technician, phlebotomy).
• Licenses and Certifications: Certified Clinical Research Coordinator (CCRC)