Protocol Specialist II, Comprehensive Cancer Center
About The Position
Under general direction, promotes exceptional clinical outcomes and patient safety by collection and communication of trial related data and information. Works in conjunction with the Principal Investigator, Research Nurse and Clinical Studies Coordinator engaged in clinical trials within the Wake Forest Baptist Comprehensive Cancer Center (WFBCCC), including institutional, cooperative group and industry sponsored trials. Performs a variety of specialized duties with regard to assigned protocols including extracting and editing data, coordinating the submission of data internally and externally to the assigned sponsor as required, and communicating with various staff and faculty members. Manages a workload successfully that includes all trial types and mentor other Protocol Specialists. Works with the PI and CPDM staff with moderate to minimal supervision by the Protocol Specialist III and direction from the Manager of Budget, Regulatory and Data Management Services.
Requirements
- High school diploma or GED equivalent with three years as a Protocol Specialist I.
- Good interpersonal, oral, written, and listening communication skills
- Knowledge of medical terminology
- Exposure to clinical trials or related health field
- Basic computer skills required, i.e. Excel, Word
- Proficiency with EPIC/WakeOne and OnCore (WISER) Clinical Trial Management System
- Ability to work effectively with other research personnel
- Demonstrates prioritization and excellent organizational skills
- Attention to detail and accuracy
- Ability to manage multiple tasks with strict timelines
- Fosters/promotes a positive image and professional appearance
- Sensitivity to intercultural relations
- Sensitivity to the maintenance of confidentiality
- Must complete the CITI certification for Human Subject Research if not already completed.
- All additional required WakeOne training for research coordinators
Nice To Haves
- SOCRA or ACRP Certification preferred.
Responsibilities
- Collects and enters patient data into appropriate registry or database that meets timelines and accuracy requirements of the sponsor or vendors.
- Extracts patient information from the electronic medical record and other source documentation for submission to study sponsor or coordinating center, to include grading of toxicities using standardized criteria.
- Ensures organized and accurate patient charts are maintained in audit-ready condition.
- Maintains OnCore (WISER) database to ensure up to date information.
- Supports exceptional relationships with sponsors by responding promptly and accurately to requests for data or information.
- Provides timely reports, quality control feedback, corrections, and necessary training.
- Monitors protocol compliance by maintaining a detailed knowledge of each assigned protocol.
- Communicates with Investigators, Protocol Specialists, Research Nurses, Clinical Studies Coordinators, ancillary departments and outside institutions regarding patients on assigned protocol.
- Completes follow-up for all assigned patient?s according to the established time frame, including continued efforts to locate patients who are lost to follow-up.
- Monitors hospital admissions of patients on assigned protocols in order to extract and report data in a timely manner, when required.
- Participates in and/or conducts audits for assigned protocols for both internal and external bodies.
- Attends relevant investigational and professional meetings and trainings. Provide staff relief as required to meet the demands of the department. Participates in scheduled team/department meetings. Leads quality improvement projects on an ongoing basis.
- Responsible for scheduling and conducting internal chart audits of peers to ensure data quality.
- Serves as back-up registrar on assigned days.
Benefits
- Paid Time Off programs
- Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
- Flexible Spending Accounts for eligible health care and dependent care expenses
- Family benefits such as adoption assistance and paid parental leave
- Defined contribution retirement plans with employer match and other financial wellness programs
- Educational Assistance Program
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
