The Protocol Development Specialist (PDS) is responsible for overseeing and facilitating the development, writing, maintenance and regulatory approval of all protocols of the Brain Cancer Program (BCP). This process involves all aspects of clinical trial development beginning with organizing BCP internal review of new clinical trial concept proposals, submitting new concepts to appropriate authorities, and upon concept approval, preparing official protocol/informed consent documents for review and approval.
The PDS works closely with the protocol study chair and other clinical investigators; the chairs of pharmacokinetics, biomarkers, imaging, and biostatistics; and BCP personnel to ensure protocol documents are written clearly, accurately, and in compliance with regulatory requirements and protocol development timelines. The PDS 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 PDS 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 PDS acts as the liaison between the sites conducting the clinical trials, the various authority entities, and industry during protocol development.
The position requires development and maintenance of a database that tracks protocol submissions, approvals, amendments, etc.
The PDS works under the direction of the BCP Program Manager. The PDS will assist the Program Manager with development, review and submission of contracts, including budgets, for industry co-sponsored protocols.
Specific Duties & 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 BCP.
Maintains excellent knowledge of all 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 IRB and FDA protocol/clinical trial regulations. Ensures that all 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 BCP 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 liaison with IRB and other authorities and handles all concept/protocol-related communications and submissions to the IRB or FDA.
Oversees development of all concepts approved and proceed as new clinical trial. Requests and obtains protocol science information from BCP discipline chairs and collaborators (study chair, statistician, correlative science, industry, etc.). Assembles, edits, and/or authors as necessary all protocol components to produce IRB-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 BCP/IRB 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 IRB comments of protocols under review. Responsible for obtaining responses from appropriate protocol contributors as necessary. Develops guidelines for protocols based on reviews.
Organizes and leads/participates in meetings with study team and others, i.e. Industry to address concerns of protocols. Updates protocol in responses to comments and discussions.
Meets regularly with BCP, study chair, study sponsors, and Program Manager to review overall protocol progress. Establishes and maintains good working relationships with FDA, industry, and other 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 IRB and industry regarding approval, amendments and revisions.
Develops and authors protocol amendments/clarifications. Prepares amendments/clarifications for submission. Posts documents and regulatory approvals to BCP 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, investigators 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 trials.
Maintains minutes on all sponsor and team teleconferences. Distributes minutes to appropriate parties as applicable.
Negotiates and makes decisions with medical monitors regarding protocol issues. Prepares documents for 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 team, industry, or study chair.
Compiles data and helps develop the final layout for 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 BCP as needed.
BA / BS degree in related discipline.
5 years related experience.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula:
* JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job. *
Experience in medical research/clinical trials, regulatory, tumor registry, or related field.
Special Knowledge, Skills, and Abilities
Excellent organizational skills required.
Excellent attention to detail skills required.
Knowledge of medical terminology desired.
Must have excellent time management skills.
Must have excellent oral and written communication skills.
Ability to multi-task in a very busy office
Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team.
Experience with IBM-PC operation.
Proven knowledge of spreadsheets, database and word processing.
Classified Title: Sr. Research Program Coordinator II Working Title: Protocol Development Specialist Role/Level/Range: ACRP/04/MC Starting Salary Range: $45,195 - $62,225; Commensurate with experience Employee group: Full Time Schedule: Monday-Friday, 8:30am- 5:00pm, Up to 37.5 hrs/ week Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10002943-SOM Onc Brain Cancer Personnel area: School of Medicine
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