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Medical Clinical Writer
18 month contract
Remote through COVID, on site when restrictions lift
Candidate will be remote only through the pandemic and then in Illinois 5 days a week, Monday– Friday
• Assist with writing and execution clinical drug trial registrations on trial registries (e.g. Clinicaltrials.gov) per the applicable regulatory and SOP requirements.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Work closely with/support the Project Manager(s) and Sr. Clinical Trial Disclosure Associate(s) of Trial Disclosure (TD): to effectively communicate information and related timelines to the applicable individuals involved in registration activities, to provide guidance and build cross-functional collaborative relationships, to coordinate the completion of these activities to achieve/ensure timely disclosure of accurate and complete information (including populating each Protocol Record with disclosure information on ClinicalTrials.gov).
• Maintain/track TD for clinical drug trials, including the documentation and storage of the information.
• Cross-train with other TD staff.
• Accountable for meeting the main objectives of assigned projects/roles and responsibilities within established timelines and with an appropriate quality level.
• Accountable to Associate Director of TD. Act as a key contributor, who exhibits a moderate level of technical competencies and requires a low level of counsel and guidance.
• Daily interaction with TD Project Manager(s) and/or Sr. Clinical Trial Disclosure Associate(s) of TD as well as significant interface/communication with cross-functional areas.
• Expedient escalation of issues to management is essential and may have a direct impact on TD compliance.
• Bachelor's degree (BA/BS), from an accredited college or university is required, preferably in a health or biological science field.
• Must have 2+ years of clinical research experience or experience in a related area such as quality or regulatory and working knowledge of drug development.
• Must be familiar with ICH and GCP Guidelines and have good organizational and communication skills and competent in application of standard business procedures (SOPs/Work Instructions, OEC).
• Must have the ability to prioritize roles and responsibilities daily and work well under deadline pressure in a team environment.
What are the top 3-5 skills requirements should this person have?
• Project Management
• Knowledge of drug development lifecycle and familiarity with clinical documents
• Demonstrated ability to manage timelines and execute to due date
• Excellent organizational skills, attention to detail, and strong oral and written communications skills
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
2+ years of clinical research experience; Bachelor’s degree (preferably in Biological Sciences or English)
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.