Company: Parexel
Position Title: Informed Consent Writer
Location: Remote
Job Type: Full Time
Job Summary:
The Informed Consent Writer (ICW) is responsible for preparing informed consent documents that disclose information about a clinical trial using health literate language to help a candidate make an informed decision about trial participation. The ICW will work across multiple therapeutic areas using Merck tools, systems, guidelines, templates, and processes.
Organizational Relationships:
- Reports to Parexel (PXL) assigned Line Management with day-to-day direction from Client
- Liaises with cross-functional lines/vendors, as appropriate
Primary Responsibilities:
- Read and understand protocol-specific design, objectives, and study procedures
- With minimal guidance from senior members of writing staff, prepare study-specific informed consent documents using established templates, information from protocols, content libraries and glossaries (when appropriate), and required risk language
- Work collaboratively with protocol authors to ensure comprehensive understanding of protocol details and the protocol approval timeline
- Write, edit, and review informed consent documents that reflect the principles of health literacy
- Manage informed consent writing projects including the design, planning, and preparation of documentation in support of clinical development to deliver high-quality clinical documentation in a timely manner
- Comfortable following directions, templates, and structured processes; and coordinate and initiate activities for document review, consensus meeting, quality control, and document finalization under aggressive timelines
- Participate, when appropriate, in clinical trial team meetings to ensure timely and consistent delivery of the informed consent document(s)
- Resolve document issues relating to informed consent
- Support Global Clinical Trial Operations with informed consent process expertise and study-specific support
- Possible participation in the orientation and coaching of junior team members
- Possible participation in initiatives to improve medical writing processes and standards
- Support tool development, enhancements, and testing, as applicable
- Ensure compliance with company training and time reporting
- Complete training assigned by Client and/or (functional service provider) FSP, including general training requirements, Policies, Standard Operating Procedures (SOPs), system, and process-related training
- Adhere to applicable Policies, SOPs, and processes
- Demonstrate commitment to Parexel’s FSP Mission, Vision, and Values, and Parexel’s “We Care” Core Values
Education and Certification:
- Life sciences degree
- 3-5 years of relevant experience preferred, including demonstrated experience translating scientific material for a lay audience
Skills and Experience:
- Understanding of protocol structure and knowledge of the relevant information needed to create an informed consent document
- Understanding of clinical trial operations with specific knowledge of informed consent forms
- Ability to prepare, with minimal supervision, a summary of a clinical trial design, objectives and activities for a lay audience using established guidelines and governmental regulations in a clear, concise, and health-literate format
- Understanding of appropriate International Council on Harmonisation (ICH) standards and regulatory guidance and company templates and processes pertaining to informed consent
- Technical expertise in MS Office (Word, Excel, Project) and Adobe Acrobat
- Experience working in document management systems; managing workflows
- Experience with collaborative authoring and review tools
- Understanding of structured content management concepts
- Flexibility in adapting to new tools and technology
- Ability to work in a deadline-driven environment, and ability to work both independently and collaboratively with teams
- Excellent communication skills (email responses, meeting presentations)
- Effective time management, organizational, and interpersonal skills
- Customer focus
- Strong project management skills
Language Skills:
- Complete fluency in reading and writing American English
For additional information and to apply for this job, click here.
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