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Research Informed Consent Editor

4 months ago

Houston, United States Houston Methodist Full time

Research Informed Consent Editor / Senior Scientific Writer

REFER A FRIEND Current Employees Apply BACK Location: Houston Methodist Academic Institute
6670 Bertner Ave
Houston, TX 77030
Job Ref: 57261 Talent Area: Quality and Research Job Shift: 1st - Day Job Type: Full-Time Posted Date: June 10, 2024

At Houston Methodist, the Senior Scientific Writer is responsible for functioning as the mentor for junior staff with an extensive knowledge of both medical and technical science while working with scientific and clinical teams to concisely and clearly communicate technical medicine and science in writing, in accordance with regulations, standards and guidelines. This role must also have familiarity with scientific and clinical research and will conduct comprehensive literature searches for writing and editing abstracts, manuscripts, review articles, grant applications, clinical study protocols, investigator brochures, consent forms, presentations and progress reports for both scientific and lay audiences.

Additional Information: 

Informed Consent Document and Patient-Facing Material Editing  Comprehensive editing and/or authoring of all informed consent documents and patient-facing materials submitted by Houston Methodist investigators. Assures compliance with applicable regulations (45 CFR 46, 21 CFR 50, ICH-GCP), local requirements, and institutional policies. Align the informed consent document with the protocol and applicable ancillary documents. Use of correct grammar and punctuation and adherence to Plain Language and health literacy principles.

Subject Matter Expert Provide guidance and subject matter expertise related to informed consents across the institution, especially in central offices, research departments, and the IRB.


Quality Improvement  Provide education, training, and collaboration as it relates to informed consent amongst central offices and research departments to streamline processes and create efficiencies.

Requirements:

PEOPLE ESSENTIAL FUNCTIONS

Subject matter expert responsible for research, writing, and editing of technical documents. Mentors and coaches other scientific writers in editing and compiling appendices of documents related to technical reports. Works with departments, agencies and sponsors to ensure that specific requirements are met with respect to document content and formatting.


SERVICE ESSENTIAL FUNCTIONS

Independently creates technical documents (collaborating with the team) based on the strategy provided, and is accountable for the format, content, and adherence to global and electronic publishing standards of the individual submission documents that he/she is the author of. Interprets data and advises faculty as how to best present data considering scientific communications best practices. Works with Principal Investigator(s) to develop, present, and bring to final submission high quality, large, multi-disciplinary, and multi-collaborative grant proposals and publications.


QUALITY/SAFETY ESSENTIAL FUNCTIONS

Prepares moderately complex documents and sections of regulatory submissions and contributes scientific knowledge and analytical skills to the preparation of grant proposals, manuscripts, presentations, protocols, and clinical regulatory documentation. Prepares technical documents that adhere to regulatory, financial, policy, and legal requirements. Assures compliance with Houston Methodist policies, rules, and regulations to meet government, publisher, and sponsor standards and research development best practices.


FINANCE ESSENTIAL FUNCTIONS

Development of grant application budgets, industry contracts and subcontracts, and other financial documents in compliance with Houston Methodist policies and procedures. Contributes to quality improvement and success of grants applications.


GROWTH/INNOVATION ESSENTIAL FUNCTIONS

Finds and implements innovations in scientific writing, grant development and research development to continuously improve best practices. Seeks opportunities to for continual professional development. Fosters a positive and constructive teaching environment by engaging students and co-workers in learning opportunities that are valuable and in alignment with business objectives.


This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.

Qualifications:

EDUCATION

Master's Degree required PhD Preferred


WORK EXPERIENCE

Six years' experience in technical or scientific writing Two years with grant applications preferred

LICENSES AND CERTIFICATIONS - REQUIRED

N/A

KNOWLEDGE, SKILLS, AND ABILITIES

Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles Ability to write in a clear, concise, and accurate language that can be understood by technical and non-technical audiences Ability to understand complex scientific information, theories, and practices. Skilled in identifying extramural funding mechanisms for faculty and programs Skilled in coordinating strategic writing projects