GENERAL SUMMARY OF DUTIES - Plan the execution and monitor the completion of complex Phase I-IV assigned clinical research protocols. Including abstracting, assembling and organizing research data while monitoring adherence to the clinical protocol and preparing reports on the data. Will work closely with the physician principal investigator, manager of data operations , clinical trial sponsor and study team.
DUTIES INCLUDE BUT ARE NOT LIMITED TO:
- Leads the execution of trials for the research team.
- Collects, completes and enters data into study-specific case report forms or electronic data capture systems within 10 business days of patient visits.
- Confirm patient eligibility and discuss discrepancies with nursing staff and physicians.
- Verify screening procedures are performed within the protocol specified window.
- Capable of handling at least 1-2 enrollments per week
- Monitor patient toxicity on trial according to Common Toxicity Criteria, including adding data to logs from source, confirming grades assigned by nursing staff, and ensuring consistency of data across the medical record.
- Planning and tracking of all assigned clinical activity in the lifecycle phases of the start up, interim and close out.
- Educates Research Nurses on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments.
- Creates study specific tools for source documentation including eligibility worksheets, screening checklists and worksheets capturing vital signs, blood sampling (as applicable).
- Ensures study specific tools, including source documents, are updated with any amendment(s) or study changes.
- Ensures pharmacist has clinical and drug supplies.
- Interfaces with laboratory technician for lab kits and processing.
- Tracks and reports adverse events, serious adverse events, protocol waivers, deviations and violations.
- Participates in monitor visits for each assigned trial at each monitoring visit.
- Reviews and comments on monitor letters within 5 business days of receipt.
- Reviews source documentation and queries for missing documentation.
- Maintains case report forms tracking management database.
- Reviews trial data for clinical relevance and answers appropriate queries.
- Apprises research scientists and management team of all study specific medical issues for guidance.
- Assists in ensuring physician oversight by updating on protocol issues and obtaining signatures and clinical significance of laboratory reports, ECGs, and adverse events.
- Assists sponsor and US FDA audit teams.
- Reviews and responds to any monitoring and auditing findings and escalates issues defined by Project Manager.
- Archives study documentation and correspondence per company policy.
- Participates in sponsor meetings when applicable.
- Reports patient visit and data entry information in financial tracking system.
- Provide required metrics to leadership.
- Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects.
- Adhere to professional standards and SOP's established for clinical research.
- Practice and adhere to the "Code of Conduct" philosophy and "Mission and Value Statement".
- During your employment with SCRI you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.
KNOWLEDGE, SKILLS & ABILITIES -This position requires the following minimal requirements
- Must have an understanding and able to analyze clinical trial data.
- Knowledge of FDA guidelines and GCP is required.
- Excellent professional writing and communication skills.
- Excellent organizational and prioritizing capabilities.
- Ability to work independently in a fast paced environment.
- Strong computer skills with demonstrated ability using clinical trial databases, electronic data capture, MS Access or Excel.
- Excellent interpersonal skills, detailed-oriented and meticulous.
- High school diploma or GED required.
- Bachelor's degree in nursing, pharmacy or other science related field or combination of equivalent education and experience.
- 3 years experience in healthcare, research or other science related field.
- 1 year experience in planning and managing clinical trial processes preferred.
- Research Professional Certification - CCRP or exam eligibility preferred.
- LPN or RN preferred.