Clinical Research Coordinator III

Panoramic Health

Come Join our team!!


The Clinical Research Coordinator III 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 an implements workflows to optimize recruitment, enrollment, and study execution. The Study Coordinator III will perform delegated duties such as protocol required visit procedures, administering questionnaires and subject material, administering and dispensing medication, adhering to regulatory guidelines, and participating in subject recruitment efforts, under the oversight of the study Principle Investigator.
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 timeline fashion to monitor letters assuring 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.
◦ Communication with location administration to make sure 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.
• Coach and mentor Research Coordinators.
• Ability to define project scope, set clear goals and expectations, prioritize activities, set milestones and follow through to successful completion.
• Perform other duties and responsibilities as required, assigned, or requested
• Days and hours of work are determined by the study (ies) need and patient scheduling.
• Travel to Investigator meetings or other study locations is expected with this position. Travel might be outside the local area and overnight.
• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 25 pounds at a time.
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 5 years to 7 years clinical research experience
• Therapeutic area experience in CKD, nephrology, or va