Clinical Research Coordinator I

St. Luke's University Health Network•Bethlehem, PA

3d•Onsite

About The Position

The Clinical Research Coordinator (CRC) assumes a critical role in the research process. The CRC is responsible for the screening, enrollment, consenting, and coordination of clinical trials ensuring compliance with the protocol and all local, state, ICH/GCP Guidelines, and Federal regulations. The CRC is also responsible for maintaining quality data for all patients enrolled into clinical trials as assigned, ensuring timely and accurate data entry for trials as assigned.

Requirements

Bachelor’s degree required; will accept Associates degree or High School degree with equivalent clinical research experience (3 years) with 1-2 years coordinator and/or data management experience highly preferred.
Must be familiar with medical terminology.
Required knowledge of Microsoft Office Programs: Word, Excel, Access, Outlook; Internet Functions.
Experience in health-related field (2 years) required.
One year experience in clinical research highly preferred.

Responsibilities

Demonstrates knowledge and practice of ICH/GCP guidelines, HIPPA Regulations and Confidentiality Policies related to clinical research
Sound conduct of the clinical trial, including but not limited to, recruitment, screening, enrollment, and follow-up of eligible subjects according to protocol requirements. This includes performing required study procedures as applicable.
Apply knowledge and skills to independently review new protocols, consents, and other clinical trials documents to ensure protocol compliance
Review and extract data from medical charts to screen patients for eligibility for assigned protocols
Review consent form, protocol procedures, and treatment regimen with potential patients and obtain consent from interested participants, documenting the consent process as required
Maintenance of accurate and complete documentation, including but not limited to regulatory documents, signed informed consent forms, source documentation, drug dispensing logs, subjects logs and study-related communication.
Organizational management of all aspects of the trial including but not limited to timeliness in completing case report forms (CRFs), data entry, reporting adverse drug events, managing caseload and managing study files.
Obtain data from other departments (radiology, pathology, etc.) as required by each protocol.
Prepare research charts for monitoring visits and audits.
Respond to data queries and collate data as requested by research group or investigator, and maintain quality source documentation.
Review charts for adverse events and submit appropriate documentation
Submit follow-up information as specified by protocol. Long-term survival follow-up may require extensive time acquiring medical records from other physician offices, patient and/or family contact, or correspondence with regulatory agencies.
Supports conduct of clinical trials, including travel to physician offices and national meetings/conferences
Communication of all protocol-related issues/problems, and other relevant study information to the appropriate medical and management staff.
Professional conduct in the presence of subjects, research staff, sponsors, monitors, etc.
Provide direction/training to other members of research staff as appropriate. For example, guidance to clinical research associate in completing case report forms.
Preparation and shipping of laboratory specimens to study (central) laboratories and maintenance of appropriate certifications related to this function (for example, IATA training).