Clinical Research Coordinator II

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.

Qualifications

• MA Certification preferred
• Bachelor’s degree in health-related field preferred
• Good Clinical Practice and or ITIA Certification preferred
• Acertified Clinical Research Professional (ACRP) or Socra Certification preferred
• Bilingual preferred (Spanish)
• Minimum 3 year’s to 5 year’s 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.