Clinical Research Program Specialist
Salary: $44,749 - $61,610
Work Schedule/Hours: m-f 8:30-5
Department name: 10002943-SOM Onc Brain Cancer
Location: 04-MD:School of Medicine Campus
Personnel area: School of Medicine
The Department of Oncology is seeking a The Protocol Writer (PW) that will be responsible for overseeing and facilitating the development, writing, and regulatory approval of all protocols of the Adult Brain Tumor Consortium (ABTC), an NCI-funded multicenter consortium of leading cancer institutions which conducts Phase I and II clinical trials for brain cancer. This process involves all aspects of clinical trial development beginning with organizing ABTC internal review of new clinical trial concept proposals, submitting new concepts/Letters of Intent for NCI review, and upon NCI concept approval, preparing official protocol/informed consent documents for NCI/FDA review and approval.
The PW works closely with the protocol study chair and other clinical investigators; the chairs of pharmacokinetics, biomarkers, imaging, and biostatistics; and ABTC Central Office personnel to ensure protocol documents are written clearly, accurately, and in compliance with NCI and FDA regulatory requirements and NCI protocol development timelines. The PW oversees the development and management of the clinical trial and develops associated strategic relationships with vendors, researchers, and clinicians in accordance with study objectives and applicable regulations. The PW is responsible for correspondence and follow-up with all appropriate parties. The position includes working with pharmaceutical industry partners on co-sponsored industry projects. The PW acts as the liaison between the sites conducting the clinical trials, the NCI, FDA, and industry during protocol development.
The position requires development and maintenance of a database that tracks NCI/FDA protocol submissions, approvals, amendments, etc.
The PW works under the direction of the ABTC Program Manager. The PW will assist the Program Manager with development, review and submission of contracts, including budgets, for industry co-sponsored protocols.
Specific Duties and Responsibilities:
- Participates in the analysis, planning and strategic formation of program goals for developing clinical trials.
- Develops an increasing understanding and complies with the policies and procedures that guide clinical research.
- Provides recommendations and input regarding departmental policies, procedures, goals and objectives; makes judgments and decisions in a sound logical manner.
- Develops project timelines and follows up with staff and PIs to ensure goals are met.
- Serves as a central resource for faculty conducting research.
- Establishes and maintains a daily routine for workflow. Establishes mechanisms for achieving study goals in conjunction with the principal investigator, industry, Program Manager, and ABTC Central Office.
- Maintains excellent knowledge of all ABTC protocols and their classification schema and updates model protocols as needed. Ensures consistency across documents and improves overall document quality.
- Maintains excellent working knowledge of NCI and FDA protocol/clinical trial regulations. Ensures that all ABTC protocols meet guidelines/regulations. Develops, maintains, and updates standard operating procedure documents as needed.
- Maintains thorough understanding of FDA Code of Federal Regulations (CFR) and International Conference on Harmonization (ICH) guidelines.
- Prepares metrics and summaries to effectively communicate trial development status and recommendations to ABTC Directors.
- Oversees internal review process of new clinical trial concepts and tracks progress. Maintains effective and timely communication with principal investigator and reviewers. Organizes meetings to discuss/vet concepts.
- Acts as ABTC liaison with NCI Protocol and Information Office and handles all concept/protocol-related communications and submissions to the NCI.
- Oversees development of all concepts approved by NCI to proceed as new clinical trial. Requests and obtains protocol science information from ABTC discipline chairs and collaborators (study chair, statistician, correlative science, industry, etc.). Assembles, edits, and/or authors as necessary all protocol components to produce NCI/FDA-compliant documents.
- Develops/authors patient informed consent documents for each protocol and ensures compliance with regulatory requirements. Designs/authors patient medication diaries and other study documents.
- Evaluates trial documents to ensure feasibility, consistency and compliance with ABTC/NCI guidelines. Reviews statistical analysis plan for consistency with study objectives, trial design.
- Organizes/leads staff meetings to review protocol documents, address inconsistencies, discuss issues, etc.
- Prepares written responses to NCI comments of protocols under review. Responsible for obtaining responses from appropriate protocol contributors as necessary. Develops guidelines for protocols based on NCI reviews.
- Organizes and leads/participates in meetings with study team and NCI to address concerns of protocols. Updates protocol in responses to comments and discussions.
- Meets regularly with ABTC Central Office, study chair, study sponsors, and Program Manager to review overall protocol progress.
- Establishes and maintains good working relationships with NCI, FDA, industry, and consortium sites. Understands the regulatory bodies of each of these groups.
- Works effectively with other staff in clinical operations (e.g., biostatistics, data management, clinical monitoring) in team situations.
- Corresponds with NCI and industry regarding approval, amendments and revisions.
- Develops and authors protocol amendments/clarifications. Prepares amendments/clarifications for submission to NCI. Posts documents and regulatory approvals to ABTC web site.
- Ensures quality control review of protocols, protocol amendments, clinical trial reports, investigator brochures, and regulatory submission documents.
- Communicates with sites about new protocols, protocol amendments/clarifications and serious adverse event (SAE) reports. Responsible for fielding questions from sites, NCI etc. regarding these documents.
- Assures protocol and study manuals have complete, consistent language throughout, including proper SAE reporting requirements, coordinating center requirements, etc.
- Maintains working log of potential industry sponsors and reports to Program Manager and directors regarding status of companies.
- Serves as primary contact with industry for initial protocol development.
- With Program Manager, works with industry in the development of scope of work. Works closely with sponsor to finalize scope of work document (part of contract).
- Assists in the development, review, and submission of contracts, including budget for industry co-sponsored ABTC trials.
- Maintains minutes on all sponsor and CTEP teleconferences. Distributes minutes to appropriate parties as applicable.
- Negotiates and makes decisions with CTEP medical monitors regarding protocol issues.
- Prepares documents for ABTC web page; updates specific areas of web site and maintains responsibility for continued updating of these web site areas.
- Determines protocol initiation timeline. Organizes initiation calls (teleconference). Creates and sends initiation package to sites. Composes minutes of teleconference and disseminates to all sites.
- Prepares reports on protocol development. Responds to special projects or queries related to the protocol from NCI, industry, or study chair.
- Compiles data and helps develop the final layout for ABTC Semi-Annual Reports. Responsible for editing entire report.
- Works with study chair to finalize data for manuscript. Assists with the draft of manuscript.
- Assists with other projects for the ABTC Central Office as needed.
BA / BS degree with course work in the sciences / health care required and requires a minimum of five years of experience in medical research/clinical trials, regulatory, tumor registry, or related field. Additional graduate education may subsitute for some experience, to the extent permitted by the JHU Equivalency Formula. Experience with IBM-PC operation necessary.
JHU Equivalency Formula:
18 graduate degree credits may substitute for one year of experience.
The successful candidate(s) for this position will be subject to a pre-employment background check.
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