Job Summary:
In collaboration with the ODE Manager, this role includes managing the training of ODEs and related documentation including SOPs, training materials, and study-specific documents. This role will consist of training new and existing staff, monitoring ongoing adherence to procedures, and retraining as needed. Additionally, this role will maintain certification, conduct evaluations, and adhering to grading protocols.
Duties and Responsibilities:
Serves as Process Owner relating to the following activities, including (but not limited to): (Percent of time: 40%)
- Management of training activities for new and existing staff.
- Tracking training in SmartSolve and on any applicable trackers.
- Running regular reports on completion and failures.
- Providing feedback to staff related to assigned training.
- Performs random quality review checks on ODE cases versus current processes. Conduct retraining with individuals as needed.
- Provides feedback and recommendations to ODEM for improvements or failures regarding existing staff and staff in training.
Attend software and other meetings as assigned by ODEM. Ensuring relevant information is incorporated into documentation or shared as needed with ODEM and ODEs.
Documentation management related to ODE training functions, as assigned by the ODEM; including (but not limited to):
- SOPs and related Work Instructions and Forms (creation, validation, and testing as applicable)
- Training documentation (e.g. TMs, CEPs, PE, Exams, etc.)
- Study-specific document collaborations (e.g. charters, SSD-WI, etc.)
Engages in miscellaneous research activities and other tasks, in support of the DIRC’s study, software, and operational objectives as assigned by the ODE Manager.
Assists with creation of metric charts and reports, including but not limited to:
- Create ODE IC and other graph slides for ODE monthly team meetings.
- Run monthly/quarterly ODE modality numbers for promotion recommendations.
Serves as ODE on DIRC projects (Percent of time: 60%):
- Maintains DIRC certification in one or more Disease Section of DIRC’s Evaluator Training program by participating in the evaluating of study cases.
- May perform as junior or senior evaluator assessment in any Disease Sections for which junior or senior evaluator certification has been attained.
- Maintains up to date knowledge of standard grading protocols and is highly familiar with study-specific grading protocols for assigned studies.
- Maintains up to date knowledge of current grading protocols, and best grading practices as defined by the ODE Manager and Principal Investigator (PI) or Medical Director.
- Understands DIRC proprietary grading software programs and successfully operates them in the conduct of grading activities.
- Checks workload daily and prioritizes cases according to the DIRC Standard Operating Procedures.
- Completes cases in a timely manner to ensure turnaround times are met.
- Adheres to the DIRC SOPs in the process of grading, routing of cases, and adjudication.
- Generates reproducible grading answers as measured by the DIRC QA re-grading process.
- Notifies ODE Manager, Project Manager, and PI of any grading protocol deviations. Immediately reports all potential Significant Medical Findings (SMFs) to the ODE Manager and PI.
- Adheres to Good Clinical Practice (GCP) documentation procedures in the recording of study data. Exhibits a low error rate in transcription and all manner of data recording.
- Contributes to the improvement of grading software programs by suggesting changes to improve quality and efficiency.
Ongoing Responsibilities:
- Perform all tasks in a safe manner in compliance with company safety policies and according to applicable regulations. Maintain a neat workstation and environment. Dress in appropriate and professional manner. Maintain clean, neat, and acceptable personal attire for job duties.
- Display courtesy and consideration to patients, guests, physicians, and staff.
- Maintain confidentiality of all records and information that pertains to patients, physicians, employees, the organization and in related interests.
Supervision:
Functions under general supervision of the DIRC Manager, Ocular Disease Evaluation.
Educational, Experience, Training:
Education:
- High School diploma required.
- Bachelor’s Degree strongly preferred.
- Combined experience/education as substitute for minimum education
Experience:
- Satisfactory knowledge of the clinical trials process, such as completion of a Clinical Research Associate training course or relevant work experience (serving as a junior ODE in the DIRC satisfies this requirement) preferred.
- Attainment of DIRC Senior ODE status in at least one DIRC Disease Section (implies a high level of competence in image grading in one or more diseases/image types) preferred.
- Strong knowledge of DIRC SOPs relevant to the grading process preferred.
Abilities and Characteristics:
- Punctuality and dependable with a strong work ethic.
- Able to perform visually intensive work on a computer monitor for long stretches.
- Strong familiarity with using Microsoft Word, Excel, Outlook, and an image editing program such as MS Paint or MS Imaging
- Critical thinking skills.
- Excellent organizational skills.
- Ability to prioritize and juggle simultaneous projects.
- Very strong attention to detail.
- Excellent communication skills, both oral and written. Able to write draft-quality procedure documents and final draft-quality correspondence. Good listening skills. Ability to relate information clearly, i.e., instructions, directions, etc.
- Resourceful, ability to identify and use available resources to accomplish tasks quickly and with little or no supervision.
- Able to train and mentor other ODEs and ODEs-in-training.
Pay: $25.64 - $28.21 per hour
Benefits:
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Retirement plan
- Vision insurance
People with a criminal record are encouraged to apply
Work Location: Remote
