Clinical Research Coordinator II

Clinical Research Coordinator II

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 coordinate multiple clinical trials and function independently; perform 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.

Knowledge, Skills, and Abilities:

• 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]

Education:

• Bachelor's [Required]

Field of Study: N/A

Work Experience: 2+ 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]

Additional Information: An equivalent combination of education ad relevant work experience may be considered in lieu of the stated degree requirement: Bachelors degree and 2+ years of experience OR Associates degree and 4+ years of experience OR Technical/Vocational School and 6+ years of clinical research experience. Other certification as applicable to degree or program (i.e., medical assistant, medical technician, phlebotomy)

Licenses and Certifications: Certified Clinical Research Coordinator (CCRC) [Preferred] Basic Life Support CPR Cert (BLS) [Preferred] Advanced Cardiac Life Support Cert (ACLS) [Preferred]

Physical Requirements: (Please click the link below to view work requirements) Physical Requirements

Pay Range: $49,307.53 $91,705.34

This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances.