Gastro Health
Senior Clinical Research Coordinator
Gastro Health, Miami, Florida, us, 33222
Gastro Health, LLC is a leading medical group made up of physicians and advanced practitioners specializing in the treatment of gastrointestinal disorders, nutrition, and digestive health. Our research division provides patient access to Phase I-IV clinical research initiatives relational to Gastroenterology and Hepatology throughout the world. Our mission is to provide outstanding medical care and an exceptional healthcare experience. Gastro Health is built on our Core Values of Compassion, Collaboration, Integrity, Empowerment, Accountability, Continuous Improvement, and Positive Attitude.
Job Summary:
Due to our rapid growth, we are currently seeking an industry professional to join our research team. This vital role will work directly with subjects, under the direct supervision of the Principal Investigator (PI). This role will be responsible for performing and implementing all aspects of clinical research trials, ensuring protocol-specific and regulatory compliance.
Responsibilities:
Coordinate and participate in site preparation for Site Initiation Visits, interim Monitoring Visits, Investigator Meetings, and Close-Out visits Ensure the safety and well-being of all study-related subjects throughout the course of their study participation Work closely with the PI to ensure compliance with protocols, and successfully conduct all assigned study-related activities in accordance with FDA and ICH GCP guidelines Ensure Standard Operating Procedures are enforced and followed with strict adherence to company policy Assure IRB approvals are obtained prior to initiating any study-related activities Recruit and track subjects with expectations for target enrollment goals Current proficiency with conducting phlebotomy Consent subjects in accordance with FDA, GCP and protocol guidelines Ensure adequate understanding of inclusion and exclusion criteria for each protocol Accurately record and communicate all adverse events (AEs) to the PI and monitor in a timely manner Record all concomitant medications and medical/surgical history accurately for each subject Schedule all subject visits within study timelines identified within the protocols Ensure subject safety and communicate safety data in a timely manner with the PI Collect and accurately record study data in source documents and case report forms Design and maintain organizational tools to conduct study activity accurately and in compliance with GCP, FDA and protocol guidelines Complete all paperwork as required by sponsor and CRA in a timely manner Why Work With Gastro Health?
When you join Gastro Health, you become part of a team dedicated to supporting clinical research and discovering new treatments for diseases, as well as new ways to detect, diagnose, and reduce the chance of developing diseases. Gastro Health, LLC employs the finest gastroenterologists, pediatric gastroenterologists, colorectal surgeons, and allied health professionals. We are always looking for individuals that share our mission to provide outstanding medical care and an exceptional healthcare experience. We offer a comprehensive benefits package to our eligible employees, which includes: Health, Dental, Vision, Paid Time Off, Life insurance, 401k, Profit Sharing Plan, Short & Long-term disability, HSA, FSA and Corporate Holidays
Qualifications:
Bachelor's Degree, preferred Availability to travel as required for training sessions 3-5 years of Clinical Research experience required Prior knowledge of clinical trials, as well as ICH-GCP principles, preferred Self-starter capable of working independently Ability to thrive in a fast-paced, high-pressure environment Desire to train and develop skills Exceptional written and oral communication skills BLS certification, preferred Familiarity with medical terminology Knowledge of how to operate/conduct and ECG/EKG Machine Skills in Phlebotomy/Venipuncture Ability to provide shadow support to entry-level research personnel Certification via SOCRA and/or ACRP Facilitation of Close-Out, Site Initiation, and Monitoring visits as required/needed Knowledge of Protocol Deviations, Serious Adverse Events, and Safety Reports 1-2 years of experience utilizing a CTMS, EDC, IWRS/IXRS, EHR (AllScripts)
Job Summary:
Due to our rapid growth, we are currently seeking an industry professional to join our research team. This vital role will work directly with subjects, under the direct supervision of the Principal Investigator (PI). This role will be responsible for performing and implementing all aspects of clinical research trials, ensuring protocol-specific and regulatory compliance.
Responsibilities:
Coordinate and participate in site preparation for Site Initiation Visits, interim Monitoring Visits, Investigator Meetings, and Close-Out visits Ensure the safety and well-being of all study-related subjects throughout the course of their study participation Work closely with the PI to ensure compliance with protocols, and successfully conduct all assigned study-related activities in accordance with FDA and ICH GCP guidelines Ensure Standard Operating Procedures are enforced and followed with strict adherence to company policy Assure IRB approvals are obtained prior to initiating any study-related activities Recruit and track subjects with expectations for target enrollment goals Current proficiency with conducting phlebotomy Consent subjects in accordance with FDA, GCP and protocol guidelines Ensure adequate understanding of inclusion and exclusion criteria for each protocol Accurately record and communicate all adverse events (AEs) to the PI and monitor in a timely manner Record all concomitant medications and medical/surgical history accurately for each subject Schedule all subject visits within study timelines identified within the protocols Ensure subject safety and communicate safety data in a timely manner with the PI Collect and accurately record study data in source documents and case report forms Design and maintain organizational tools to conduct study activity accurately and in compliance with GCP, FDA and protocol guidelines Complete all paperwork as required by sponsor and CRA in a timely manner Why Work With Gastro Health?
When you join Gastro Health, you become part of a team dedicated to supporting clinical research and discovering new treatments for diseases, as well as new ways to detect, diagnose, and reduce the chance of developing diseases. Gastro Health, LLC employs the finest gastroenterologists, pediatric gastroenterologists, colorectal surgeons, and allied health professionals. We are always looking for individuals that share our mission to provide outstanding medical care and an exceptional healthcare experience. We offer a comprehensive benefits package to our eligible employees, which includes: Health, Dental, Vision, Paid Time Off, Life insurance, 401k, Profit Sharing Plan, Short & Long-term disability, HSA, FSA and Corporate Holidays
Qualifications:
Bachelor's Degree, preferred Availability to travel as required for training sessions 3-5 years of Clinical Research experience required Prior knowledge of clinical trials, as well as ICH-GCP principles, preferred Self-starter capable of working independently Ability to thrive in a fast-paced, high-pressure environment Desire to train and develop skills Exceptional written and oral communication skills BLS certification, preferred Familiarity with medical terminology Knowledge of how to operate/conduct and ECG/EKG Machine Skills in Phlebotomy/Venipuncture Ability to provide shadow support to entry-level research personnel Certification via SOCRA and/or ACRP Facilitation of Close-Out, Site Initiation, and Monitoring visits as required/needed Knowledge of Protocol Deviations, Serious Adverse Events, and Safety Reports 1-2 years of experience utilizing a CTMS, EDC, IWRS/IXRS, EHR (AllScripts)