Panoramic Health
Clinical Research Coordinator II | Boca Raton
Panoramic Health, Boca Raton, Florida, us, 33481
Overview
Clinical Research Coordinator II | Boca Raton Posted Tuesday, September 9, 2025 at 4:00 AM The Clinical Research Coordinator II leads the clinical research program at the site level: effectively recruiting and enrolling research patients under the clinical direction of the principal investigator, and always in compliance with institutional Standard Operating Procedures, protocol specifications, and good clinical practice. In addition, proactively develops and implements workflows to optimize recruitment, enrollment, and study execution. Responsibilities
Read and understand assigned research protocols. Prescreen patients. Train site staff on study purpose, record attendance. Evaluate resources needed and on-hand to appropriately deploy the study. Proactively recruit potentially eligible patients for research studies by communicating eligibility criteria and flagging potentially eligible patients to referring physicians and clinic staff. Work collaboratively with clinic leadership and staff to identify and implement effective processes for communicating study opportunities to patients and providers. Work collaboratively with central Research departments, including Central Enrollment Team, to meet and exceed targets for referrals, consents and enrolled patients. Obtain and document informed consent per ICH/GCP and site SOPs. Timely, clean data entry according to ALCOA principle ("Attributable, Legible, Contemporaneous, Original and Accurate"). Prepare for monitoring visits: All Source Documents organized and readily available. Responds in a timely fashion to monitor letters ensuring all outstanding items from prior monitoring visit are resolved. No open queries from prior visit. Temperature and accountability logs are kept current and readily available. Ongoing study oversight and management: Plan subject visits according to protocol specific visit schedule. No protocol deviations due to out-of-window procedures. Communicate with location administration to ensure space and other resources are available as needed. Reporting of Adverse and Serious Adverse Events to IRB, Sponsor and management in accordance with reporting guidelines. Dispensing/collecting study medication and providing accurate Investigational Product accountability. Collecting and processing subject laboratory specimens according to protocol. Completing case report forms (CRFs) and other patient tracking information (either electronic or manual) accurately and on a timely basis as assigned. Maintaining a thorough understanding of all data collection instruments and collecting data accurately and according to protocol. Communication with location administration to make sure space and other resources are available as needed. Reporting of Adverse Events to IRB, Sponsor and management in accordance with reporting guidelines. Dispensing and collecting medication and providing accurate Investigational Product accountability. Collecting and processing subject laboratory specimens according to protocol. Completing case report forms (CRFs) and other patient tracking information (either electronic or manual) accurately and on a timely basis as assigned. Maintaining a thorough understanding of all data collection instruments and collecting data accurately and according to protocol. Perform other duties and responsibilities as required, assigned, or requested. Qualifications
MA Certification preferred Bachelor’s degree in health-related field preferred Good Clinical Practice and/or ITIA Certification preferred ACRP or Socra Certification preferred Bilingual preferred (Spanish) Minimum 3 to 5 years clinical research experience Therapeutic area experience in CKD, nephrology, or vascular access a plus Must have knowledge of medical terminology/research Self-motivated individual who will drive patient safety, achievement of enrollment targets, quality timely data entry, and adherence to Good Clinical Practice (GCP). Requires excellent interpersonal and communication skills. Requires flexibility, excellent organizational/communication skills, and attention to detail. Knowledge of and adherence to Good Clinical Practice (GCP), IATA and FDA regulations. Must be able to do basic clinical procedures such as: blood work, vitals, height, weight, etc. Must be able to do an ECG. Must be able to multitask, able to handle a high volume of patients across multiple studies. Open to working a flexible schedule. Equal Employment Opportunity
The Company is committed to the principles of equal employment and to complying with all federal, state, and local laws providing equal employment opportunities, and all other employment laws and regulations. It is our intent to maintain a work environment free of harassment, discrimination, or retaliation because of age, race, color, national origin, ancestry, religion, sex, pregnancy (including childbirth, lactation and related medical conditions), physical or mental disability, genetic information (including testing and characteristics), veteran status, uniformed servicemember status, or any other status protected by law. The company is dedicated to the fulfillment of this policy in regard to all aspects of employment. For information about our Privacy Policy, please visit here.
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Clinical Research Coordinator II | Boca Raton Posted Tuesday, September 9, 2025 at 4:00 AM The Clinical Research Coordinator II leads the clinical research program at the site level: effectively recruiting and enrolling research patients under the clinical direction of the principal investigator, and always in compliance with institutional Standard Operating Procedures, protocol specifications, and good clinical practice. In addition, proactively develops and implements workflows to optimize recruitment, enrollment, and study execution. Responsibilities
Read and understand assigned research protocols. Prescreen patients. Train site staff on study purpose, record attendance. Evaluate resources needed and on-hand to appropriately deploy the study. Proactively recruit potentially eligible patients for research studies by communicating eligibility criteria and flagging potentially eligible patients to referring physicians and clinic staff. Work collaboratively with clinic leadership and staff to identify and implement effective processes for communicating study opportunities to patients and providers. Work collaboratively with central Research departments, including Central Enrollment Team, to meet and exceed targets for referrals, consents and enrolled patients. Obtain and document informed consent per ICH/GCP and site SOPs. Timely, clean data entry according to ALCOA principle ("Attributable, Legible, Contemporaneous, Original and Accurate"). Prepare for monitoring visits: All Source Documents organized and readily available. Responds in a timely fashion to monitor letters ensuring all outstanding items from prior monitoring visit are resolved. No open queries from prior visit. Temperature and accountability logs are kept current and readily available. Ongoing study oversight and management: Plan subject visits according to protocol specific visit schedule. No protocol deviations due to out-of-window procedures. Communicate with location administration to ensure space and other resources are available as needed. Reporting of Adverse and Serious Adverse Events to IRB, Sponsor and management in accordance with reporting guidelines. Dispensing/collecting study medication and providing accurate Investigational Product accountability. Collecting and processing subject laboratory specimens according to protocol. Completing case report forms (CRFs) and other patient tracking information (either electronic or manual) accurately and on a timely basis as assigned. Maintaining a thorough understanding of all data collection instruments and collecting data accurately and according to protocol. Communication with location administration to make sure space and other resources are available as needed. Reporting of Adverse Events to IRB, Sponsor and management in accordance with reporting guidelines. Dispensing and collecting medication and providing accurate Investigational Product accountability. Collecting and processing subject laboratory specimens according to protocol. Completing case report forms (CRFs) and other patient tracking information (either electronic or manual) accurately and on a timely basis as assigned. Maintaining a thorough understanding of all data collection instruments and collecting data accurately and according to protocol. Perform other duties and responsibilities as required, assigned, or requested. Qualifications
MA Certification preferred Bachelor’s degree in health-related field preferred Good Clinical Practice and/or ITIA Certification preferred ACRP or Socra Certification preferred Bilingual preferred (Spanish) Minimum 3 to 5 years clinical research experience Therapeutic area experience in CKD, nephrology, or vascular access a plus Must have knowledge of medical terminology/research Self-motivated individual who will drive patient safety, achievement of enrollment targets, quality timely data entry, and adherence to Good Clinical Practice (GCP). Requires excellent interpersonal and communication skills. Requires flexibility, excellent organizational/communication skills, and attention to detail. Knowledge of and adherence to Good Clinical Practice (GCP), IATA and FDA regulations. Must be able to do basic clinical procedures such as: blood work, vitals, height, weight, etc. Must be able to do an ECG. Must be able to multitask, able to handle a high volume of patients across multiple studies. Open to working a flexible schedule. Equal Employment Opportunity
The Company is committed to the principles of equal employment and to complying with all federal, state, and local laws providing equal employment opportunities, and all other employment laws and regulations. It is our intent to maintain a work environment free of harassment, discrimination, or retaliation because of age, race, color, national origin, ancestry, religion, sex, pregnancy (including childbirth, lactation and related medical conditions), physical or mental disability, genetic information (including testing and characteristics), veteran status, uniformed servicemember status, or any other status protected by law. The company is dedicated to the fulfillment of this policy in regard to all aspects of employment. For information about our Privacy Policy, please visit here.
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