Clinical Research Coordinator III

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.
• Coach and mentor Research Coordinators.
• Able 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.

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 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.