Essential Job Duties:
- Responsible for development, review, finalization, and maintenance of clinical trial documents such as informed consent form and other relevant documents
- Applies knowledge of GCP Guidelines, regulatory requirements, regulatory framework of privacy standards and biological samples standards, therapeutic area(s), and Investigational Medicinal Products (IMPs) to review and develop Informed Consent Forms (ICF) and other related documents
- Ensures that the content of Master Informed Consent Form is consistent with the corresponding protocol and fully informs the subject of all information about the research study that a potential research subject would need to know in order to decide if they want to enroll in the study.
- Ensures that the content and the scientific and medical language of the consent form can be easily understood by research participants
- Ensures that documents are written/edited in compliance with the global industry standards
- Ensures client specific guidance and requirements are included within the Master Informed consent form during development and review
- Supports the development, Review and approval of master templates to ensure effective and timely execution of protocol/site activation
- Assist/Support in development of any ancillary documents requested by study teams in relation to ICF.
- Actively remains current with industry standards, trends, and competitive intelligence on regulatory documents best practices
- Adheres to the required metrics and tools to report the outcomes to analyze performance and deliverables
- Work Closely with Quality teams in implementation of best practices
- Create, review and revise training material and plans to support the training requirements of the team.
- Ensure training resources are kept up to date with the changes in procedures.
- Generate monitoring processes to ensure that trainees are competent to perform job duties.
- Follow applicable departmental Standard Operating Procedures and Work Instructions.
- Complete all assigned/required trainings within the due dates/timelines.
- Responsible for timely and appropriate communication to all stake holders, as applicable
- Liaise with PM/Designee to communicate any trends, outstanding issues, safety concerns or any other activity or lack thereof which may jeopardize the clinical trial delivery or patient safety from task assigned.
University/College Degree (medical degree preferred)
Certification from an appropriate accredited institution (Ex: Nursing certification, Medical or Dental, etc…)
Strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations.
In addition to above, Candidates without medical/life sciences background but with relevant domain knowledge and experience may be considered, if deemed appropriate for specific tasks and activities.Experience: Minimum Required:
- Years of experience in the job discipline: Minimum 5 Years
- Other required work-related experiences:
- Strong knowledge of the drug development process
- Good understanding of FDA IND/NDA requirements
- Strong understanding of regulations, policies and procedures concerning the conduct of clinical trials including FDA regulations, biological samples regulations, GDPR and GCP guidelines
- Preferred previous experience in writing and editing master informed consent forms and other clinical trial related documents
- knowledge and understanding of medical terminology, Health Literacy principles is a plus
- Experience in initiating and leading cross functional deliverables is a plus
- The work requires long periods of sitting, reading, and mental concentration
- Excellent customer service/ management skills
- Computer skills with excellent proficiency in MS word
- Excellent command on English language along with written and verbal communication skills
- Ability to Influence stakeholders through insight on industry trends
- Demonstrated ability to plan, prioritize and deliver timely.
- Demonstrated ability to pay attention to detail.
- Ability to deliver consistent high quality of work.
- Ability to negotiate with others.
- Ability to mentor and train others
- Maintain cross departmental synergies
- Ability to adopt to this fast-paced, dynamic environment
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