Clinical Trial Assistant (CTA)

Job Summary Colorado ENTAllergy is the premier (and the largest) ENT practice in the state of Colorado. We are dedicated to providing the most exceptional ear, nose, throat, allergy, asthma and sleep medicine care to our patients. To accomplish this goal, we continuously promote advancements in clinical practice through clinical trials and the utilization of state-of-the-art technology which benefits both our patients and employees. A Clinical Trial Assistant (CTA) provides critical administrative and operational support to clinical research teams. CTAs help keep drug and medical device studies organized, compliant with regulations, and on schedule by managing essential documentation, tracking trial milestones, and facilitating communication across the study team.

Primary Responsibilities Document Management:

Organizing, tracking, and filing essential trial documents (e.g., CVs, protocols, and informed consent forms) in the Clinical Trial management systems (CTMS).

Study Tracking:

Maintaining clinical trial management systems (CTMS) and tracking project milestones, site compliance, and patient data flow.

Team Coordination:

Scheduling meetings, organizing study supplies, and facilitating communication between site, sponsors, and Clinical Research Associates (CRAs).

Compliance:

Ensuring all trial activities strictly adhere to International Council for Harmonisation and Good Clinical Practice (ICH-GCP) guidelines and standard operating procedures (SOPs).

Site Support:

Assisting Clinical Research Coordinators (CRC) with day-to-day operational queries and administrative tasks. Other duties as assigned. Competencies To perform the job successfully, an individual should demonstrate the following competencies: Analytical

• Collects and researches data; Uses intuition and experience to complement data. Design
• Generates creative solutions; Demonstrates attention to detail. Problem Solving
• Identifies and resolves problems in a timely manner; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics. Interpersonal Skills
• Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things. Oral Communication
• Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Participates in meetings. Written Communication
• Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information. Teamwork
• Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed. Organizational Support
• Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity. Strategic Thinking
• Develops strategies to achieve organizational goals; Adapts strategy to changing conditions. Motivation
• Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence. Planning/Organizing
• Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives. Adaptability
• Adapts to changes in the work environment; Able to deal with frequent change, delays, or unexpected events.

Requirements Excellent written and verbal communication skills, interpersonal, analytical, and problem-solving skills. Superior organizational and time management skills. Capable of working independently with minimal supervision and also as part of a team. Skilled with standard computer programs including the MS Office suite. Understanding of medical terminology as well as standard clinical procedures and protocols, and GCP/ICH Guidelines. Work Environment This position will be performed on site in a medical office setting at 6031 E Woodmen Rd, Suite 300 Colorado Springs, CO 80923. Monday-Thursday 7am-4pm and Friday 7am-1pm. Compensation Salary Range $20

• 22/hour Benefits
• medical insurance and 401K Paid Time Off