Clinical Research Coordinator

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join us as a Clinical Research Coordinator - And play a key role in overseeing clinical site activities and ensuring high standards of patient care and data integrity.

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 are not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.).

* Record all patient information and results from tests as per protocol on required forms.

* Where required, may complete IP accountability logs and associated information.

* Reports suspected non-compliance with relevant site staff.

* Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.

* Promotes 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.

* May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.

* Logs/complete information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.

* Gather and maintain source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.

* Adhere to company COP/SCOP.

* May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.

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 2+ 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:

* Solid 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

* Good decision-making, negotiation and influencing skills

* Good communication skills and English fluency will be an advantage

* Good organizational skills

* Good proficiency in basic computer applications

* Good 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…