Clinical Research Coordinator III

What You’ll Do

• Conduct clinical studies according to FDA/GCP and ICH regulations and guidelines.
• Provide medical care to patients, always ensuring patient safety comes first.
• Schedule subject visits within protocol windows, ensuring scheduling capacity is maximized.
• Perform all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG's, blood samples, etc.).
• Record all patient information and results from test as per protocol on the required forms.
• Where required, may complete IP accountability logs and associated information.
• Report suspected of non-compliance to relevant site staff.
• Ensure that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
• Promote the company and builds a positive relationship with patients to ensure retention.
• Attend site initiation meetings and all other relevant meetings to receive training on protocol.
• Review the plan for study conduct for multiple assigned studies and determine how to accomplish. Identify and communicate any obstacles impeding efficient study conduct.
• Accurately collect and document data. Ensure correct study documents and Computer generated forms are used in compliance with protocol.
• Ensure that timelines are met by working with relevant staff.
• Monitor safety and well-being of all study participants through direct and indirect interaction with subjects, and communicate problems to relevant stakeholders.
• Perform clinical assessments of participants, monitor laboratory safety reports, and communicate any serious or potentially serious adverse events as per the company procedure.
• Serve as a primary point of sponsor contact for all research activities for studies assigned.
• Ensure all communications are documented and shared with the appropriate team members.
• Act as a back-up to direct people manager. This includes but is not limited to, overseeing and assigning work to team members, scheduling, and monitoring time. Involved in the interview and hiring process of new team members. Assist in the training of new team members and providing mentoring. Provide input into evaluations performance reviews of team members. Perform other study related duties as qualified by documented training.

Education and Experience

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification BLS certificate required.
• Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 5+ years’).

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities

• Thorough understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.)
• Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving
• Demonstrated ability to exercise discretion and sound judgement
• Solid decision-making, negotiation and influencing skills
• Strong communication skills and English fluency will be an advantage
• Strong organizational skills
• Strong proficiency in basic computer applications
• Solid interpersonal skills to work in a team environment

Working Conditions and Environment

• Work is performed in an office/ laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment is required such as protective eyewear, garments and gloves.
• Occasional travel may be domestic or international.

Physical Requirements

• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.