Research Specialist ; AES

· Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.

· Provides medical care to patients, always ensuring patient safety comes first.

· Performs 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, etc.).

· Records 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 to 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.

· Attends 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/completes 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.

· Gathers source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.

· Adheres 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.

· Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.

· Provides medical care to patients, always ensuring patient safety comes first.

· Performs 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, etc.).

· Records 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 to 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.

· Attends 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/completes 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.

· Gathers source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.

· Adheres 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 in the clinical / medical field

BLS certificate required.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 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:

· Basic 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

· Adequate decision-making, negotiation and influencing skills

· Decent communication skills and English fluency will be an advantage

· Decent organizational skills

· Essential proficiency in basic computer applications

· Decent interpersonal skills to work in a team environment

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field

BLS certificate required.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 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:

· Basic 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

· Adequate decision-making, negotiation and influencing skills

· Decent communication skills and English fluency will be an advantage

· Decent organizational skills

· Essential proficiency in basic computer applications

· Decent interpersonal skills to work in a team environment