Clinical Research Coordinator - Langhorne

Clinical Research Coordinator I 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 Principal Investigator. The Clinical Research Coordinator needs to engage with the Principal Investigators, pharmaceutical companies (Sponsors) and contract research organizations (monitors) as well as the research subjects.

Responsibilities include:

• 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.
• Drive enrollment to meet contractual targets: Using the EMR, screen for eligible patients for discussion and qualification by the Principal Investigator. 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. All outstanding items from prior monitoring visit are resolved. No open queries from prior visit. Temperature and accountability logs 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 and Sponsor 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.
• Perform other duties and responsibilities as required, assigned, or requested.

Qualifications:

• Bachelors' degree required; Nursing or Health Science preferred.
• Bilingual preferred (Spanish).
• Minimum 2 years' experience as a Clinical Research Coordinator.
• Therapeutic area experience in CKD, nephrology, or vascular access a plus.
• 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.
• Travel to Investigator meetings or other study locations is expected with this position. Travel might be outside the local area and overnight.