Description
The Clinical Research Coordinator assists in the daily activities of clinical research studies, obtains informed consent; collects, maintains and organizes study information. Assists in preparing grant applications and documents (for e.g., Institutional Review Board, Grants and Contracts Office).

Responsibilities

• Coordinates the clinical assessments of the study subjects including but not limited to screening and evaluation of the study subjects.
• Ensures accurate and complete compilation of subject data through chart reviews.
• Assists the Principal Investigator and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials.
• Obtains informed consent under minimal supervision of the investigator(s) and educates participants regarding study requirements.
• Assists in the activities related to clinical research studies including but not limited to: answering phone calls, screening participants for eligibility, registering subjects with sponsoring agency, administering lifestyle questionnaires.
• Maintains source documents and subject files in accordance with hospital procedures. Ensures accurate and complete compilation of subject data through chart reviews. Inputs all information into database.
• Obtain, process, store, and ships clinical specimens as required by the protocol.
• Prepares for monitoring visits.
• Support the regulatory affairs team to ensure compliance with FDA regulations, ICH-GCP guidelines, and other relevant local and international regulations for clinical trials and studies
• Maintains the electronic Trial Master File (eTMF) and ensuring compliance with regulatory requirements
• Work closely with cross-functional teams to ensure that regulatory documentation is accurate, complete, and submitted in a timely manner
• Ensure the integrity of clinical trials, maintaining regulatory compliance and contributing to the overall success of research initiatives
• Additional duties include operational assistance with other essential systems, as well as a variety of special projects; once an understanding of the general duties listed below has been acquired, this individual will coordinate efforts to achieve the performance improvement and systems integration goals of the PCTO

Qualifications

• Bachelors or Masters degree in Science or closely related field.
• 1-2 years of research experience

Employer Description

• Coordinates the clinical assessments of the study subjects including but not limited to screening and evaluation of the study subjects.
• Ensures accurate and complete compilation of subject data through chart reviews.
• Assists the Principal Investigator and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials.
• Obtains informed consent under minimal supervision of the investigator(s) and educates participants regarding study requirements.
• Assists in the activities related to clinical research studies including but not limited to: answering phone calls, screening participants for eligibility, registering subjects with sponsoring agency, administering lifestyle questionnaires.
• Maintains source documents and subject files in accordance with hospital procedures. Ensures accurate and complete compilation of subject data through chart reviews. Inputs all information into database.
• Obtain, process, store, and ships clinical specimens as required by the protocol.
• Prepares for monitoring visits.
• Support the regulatory affairs team to ensure compliance with FDA regulations, ICH-GCP guidelines, and other relevant local and international regulations for clinical trials and studies
• Maintains the electronic Trial Master File (eTMF) and ensuring compliance with regulatory requirements
• Work closely with cross-functional teams to ensure that regulatory documentation is accurate, complete, and submitted in a timely manner
• Ensure the integrity of clinical trials, maintaining regulatory compliance and contributing to the overall success of research initiatives
• Additional duties include operational assistance with other essential systems, as well as a variety of special projects; once an understanding of the general duties listed below has been acquired, this individual will coordinate efforts to achieve the performance improvement and systems integration goals of the PCT