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Clinical Research Coordinator II- Precision Medicine

St. Luke's Health Network, Inc.

Allentown, PA

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
Adverse Events, Case Management, Case Report Form (CRF), Clinical Research, Clinical Trial, Clinical Trial Management, Data Entry, Data Management, Documentation, Event Management, Federal Laws and Regulations, GCP (Good Clinical Practices), HIPAA (Health Insurance Portability and Accountability Act), Healthcare, Healthcare Providers, ICH Regulations, Maintain Compliance, Medicine, Microsoft Access Database, Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft Word, Nursing, Organizational Skills, Pathology, Phlebotomy, Quality Management, Radiology, Regulations, Sample/Specimen Processing, Society of Clinical Research Associates (SoCRA)
LOCATION
Allentown, PA
POSTED
27 days ago
St. Luke's is proud of the skills, experience and compassion of its employees. The employees of St. Luke's are our most valuable asset! Individually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care. The Clinical Research Coordinator II 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.JOB DUTIES AND RESPONSIBILITIES: Demonstrates knowledge and practice of ICH/GCP guidelines, HIPPA Regulations and Confidentiality Policies related to clinical researchSound 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 applicableApply knowledge and skills to independently review new protocols, consents, and other clinical trials documents to ensure protocol complianceReview and extract data from medical charts to screen patients for eligibility for assigned protocolsReview consent form, protocol procedures, and treatment regimen with potential patients and obtain consent from interested participants, documenting the consent process as requiredMaintenance 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 communicationOrganizational 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 filesObtain data from other departments (radiology, pathology, etc.) as required by each protocolPrepare research charts for monitoring visits and auditsRespond to data queries and collate data as requested by research group or investigator, and maintain quality source documentation PHYSICIAL AND SENSORY REQUIREMENTS: Requires sitting for up to seven hours per day, 4 hours at a time. Standing for up to 4 hours per day, 3 hours at time. Requires frequent fingering, handling and twisting and turning. Occasionally requires lifting, carrying and pushing and pulling objects weighing up to 25 pounds. Occasionally requires reaching above shoulder level. Must have the ability to hear as it relates to normal conversation, seeing as it relates to general vision. EDUCATION: Bachelor’s degree with 3+ years of direct clinical research coordinator experience required. Clinical Research certification (e.g. SoCRA, ACRP, etc.) highly preferred. TRAINING AND EXPERIENCE: Required knowledge of Microsoft Office Programs: Word, Excel, Access, Outlook; Internet Functions. Must be willing and able to draw and process blood specimens with current phlebotomy training or completion of phlebotomy training within 2 months of hire. Please complete your application using your full legal name and current home address. Be sure to include employment history for the past seven (7) years, including your present employer. Additionally, you are encouraged to upload a current resume, including all work history, education, and/or certifications and licenses, if applicable. It is highly recommended that you create a profile at the conclusion of submitting your first application. Thank you for your interest in St. Luke's!!St. Luke's University Health Network is an Equal Opportunity Employer.

About the Company

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St. Luke's Health Network, Inc.