Clinical Research Coordinator I

About the role

To serve as a clinical research coordinator during the conduct of clinical research at the investigative site. Works under the direct supervision of the Principal Investigator. Coordinates all activities for the implementation and conduct of clinical trials. Responsible for the collection, accuracy, and validity of data for assigned clinical studies in accordance with the study protocol and study timelines. Responsible for the collection and submission of regulatory documents, performance of study specific procedures and regulatory reporting requirements as instructed by the Principal Investigator and governed by Good Clinical Practice and International Council for Harmonization. Works under the supervision of the Principal Investigator to conceptually apply research protocol to clinical setting to allow for accurate and timely completion of all duties. Maintains all appropriate documentation associated with the assigned clinical study. Ensures studies are conducted according to established organization policies and procedures as well as all applicable State and Federal regulations, specifically Good Clinical Practice, International Council for Harmonization and Food and Drug Administration guidelines. This position is designated as an on-site, patient-facing role. In-office presence is an essential function due to the need for real-time collaboration with providers, direct interaction with patients and caregivers, and secure handling of health data in compliance with HIPAA.

Responsibilities

• Coordinate all aspects of clinical research activities for assigned studies at investigative site
• Maintain all appropriate documentation associated with the assigned clinical study
• Collect, submit, and maintain regulatory documents and perform study-specific procedures
• Ensure studies are conducted according to established organization policies and procedures and all applicable State and Federal regulations
• Provide support to offsite locations as necessary
• Participate in a 24-hour emergency on-call rotation
• Travel to attend off-site meetings as necessary and directed
• Delegate tasks to clinical research assistants and clinical research administrative assistants as applicable
• Assist in patient transfer using appropriate techniques and equipment

Requirements

• 2 to 4 years of healthcare experience or 2 to 4 years as a Clinical Research Assistant, or any combination of the two
• Certified Medical Assistant required
• Healthcare and/or research experience preferred
• Skilled in the use of personal computers and related software applications, including Microsoft Office and email
• Valid driver’s license and reliable transportation
• Ability to provide a minimum of a 4-week notice in the event resignation is tendered

Knowledge, Skills, and Abilities

• Excellent record maintenance skills
• Ability to communicate effectively both orally and in writing
• Proactive self-starter with the ability to function independently in a fast-paced, challenging environment
• Maintain a positive and professional attitude in all aspects of work from patient care to interaction with coworkers and physicians
• Demonstrated human relations and effective communication skills
• Understand the ethics of confidentiality and maintain confidentiality of sensitive information
• Willing to pursue research certification when eligible
• Maintain confidentiality of patients and their medical information
• Maintain confidentiality of research activities as required by study sponsor confidentiality agreements and mandates
• Ability to meet deadlines for multiple concurrent projects
• Ability to understand and follow policies, procedures, and direction
• Willingness to accept orders and perform repetitive tasks
• Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community
• Ability to make evaluative judgments
• Ability to function well while involved in multiple task assignments
• Ability to concentrate on details and deal with constant interruptions
• Skill in organizing resources and establishing priorities
• Ability to delegate tasks to clinical research assistants and clinical research administrative assistants as applicable

Physical Demands

• The employee may be required to assist in patient transfer and should use appropriate techniques and equipment to safely transfer patients
• Hearing, visual acuity, depth perception, balancing, handling, and talking; requires full range of body motion
• Reaching, grabbing, holding – fine motor skills with dexterity and eye-hand coordination
• Extended periods in a stationary or standing position
• Repetitive motion such as entering data into computer-based programs
• Lift or move up to 30 pounds; use appropriate ergonomics and tools such as hand carts for heavier loads

Work Environment

• Work is normally performed in a typical interior/office work environment with moderate noise level
• Position requires visual acuity (corrected or uncorrected)
• Moderate risk of exposure to blood borne pathogens and other potentially infectious materials