Schedule:

Full time

Shift:

Day (United States of America)

Address:

2525 S DOWNING ST

City:

DENVER

State:

Colorado

Postal Code:

80210

Job Description:

Other duties as assigned. Delivers effective and compliant clinical research study coordination, including planning, organizing, and managing all activities related to clinical research protocols. Serves in a supportive role for the preceptorship of new team members, monitoring their progress and providing open communication to the Operational Manager. Manages the clinical space necessary for the execution of clinical research protocols, overseeing set-up and turnover procedures per SOPs. Maintains adequate skills in clinical competencies including physical assessment, phlebotomy, and IV insertion, and practices the principles of Universal Precautions. Ensures teams maintain adequate inventory levels, order approved equipment and supplies, and maintain clinical supply areas. Develops and maintains Standard Operating Procedures (SOPs) and ensures clinical research operations teams follow established processes and procedures. Provides guidance, education, specialized training, and mentorship to promote growth for study team members. Leads the Talent Acquisition process, team development, and performance management of research team members. Serves as a service line expert and resource for the research team, addressing barriers during day-to-day operations. Manages the delivery safe care with regard for the dignity and respect of all patients/participants. Supervises day-to-day activity of the clinical research team, including oversight of productivity and maintenance of personnel and staffing schedules. Builds and maintains supportive relationships with each team members through regular rounding and scheduled connections. Monitors and evaluates the quality and safety of clinical operations within assigned areas. Collaborates with operations manager, study intake, research services, and external partners to ensure timely start-up and smooth transition to assigned coordinator. Knowledge, Skills, and Abilities:
• Identified ability to supervise clinical research teams, lead and accept responsibility, exercise authority, and function independently using effective written and verbal communication in English.
• Demonstrated ability to perform clinical tasks assisting physicians, mid-level providers, and CRN with minor procedures and other study requirements within scope of practice.
• Acclimate and integrate into various clinical settings as needed per study protocol.
• Demonstrated skills in clinical competencies including physical assessment, phlebotomy, IV insertion, and administration of investigational drugs in accordance with policies and procedures.
• Knowledge of Federal regulations: Food and Drug Administration (FDA), Centers for Disease Control (CDC), Department of Health and Human Services (DHHS) governing the conduct of clinical research.
• Specialized knowledge of the unique needs of volunteers and patients participating in clinical trials.
• Proficiency with coordination of multiple clinical trials, while providing supervisory support to the team.
• Demonstrated ability to critically think in a fast-paced environment, with an analytical approach to problem-solving.
• Sensitivity to cost-containment measures and ability to create an atmosphere which encourages this practice.
• Proficient with a clinical trials management system (CTMS).
• Proficiency in Microsoft Outlook, Word, Excel, and Access and ability to learn business-relevant software and tools.
• Reliability and promptness in completing administrative assignments effectively.
• Leadership ability, accepts responsibility, exercises authority, and functions independently using effective written and verbal communications.
• In-depth knowledge of the regulatory process that oversees investigational research.
• Ability to conduct Human Resources-related functions to support the research team.
• Plan, organize, direct, and oversee all activities related to clinical research.
• Bilingual (English/Spanish) Preferred.

Education:
• Associate's of Nursing [Required]
• Bachelor's of Nursing [Preferred]
Field of Study:
• in Healthcare, Business or related field
• in Healthcare, Business or related field

Work Experience:
• 2+ clinical research experience [Required]
• 4+ clinical research experience with increasing people management responsibilities [Preferred]
• 5+ people management experience [Preferred]
Additional Information:
• N/A

Licenses and Certifications:
• Certified Clinical Research Coordinator (CCRC) [Required]
• Society of Clinical Research Associates (SOCRA) [Required]
• Basic Life Support - CPR Cert (BLS) [Required]
• Advanced Cardiac Life Support Cert (ACLS) [Preferred]
• Registered Nurse (RN) [Required]
Physical Requirements: (Please click the link below to view work requirements)
Physical Requirements - https://tinyurl.com/msy4mja2

Pay Range:

$74,422.15 - $138,421.86