At K2 Medical Research, a privately-owned clinical research facility in the greater Orlando and Central Florida area, we specialize in conducting multiphasic clinical trials that promote the development of innovative and effective medical treatments while maintaining the safety and privacy of our participants. We are committed to fighting the diseases that plague our loved ones and ourselves. By harnessing the power of advanced clinical research and connecting our patients with the treatments of tomorrow, we can improve the health of our local communities, and by extent, the population of our world.
K2 has an exciting remote opportunity for a Source Document Specialist with clinical research experience.
Description:
Responsible for the creation and management of source documents, both paper and electronic. This position serves as a subject matter expert on the formatting of source documents and ensures all required data points are sufficiently captured in a manner consistent with protocol requirements and Good Clinical Practice (GCP). This role requires extensive collaboration with site staff and the ability to extract details from study documents and present them in a user-friendly format.
Primary Responsibilities:
• Create and revise source document templates, both paper and electronic, for all new clinical trials.
• Review & utilize multiple resources (i.e. protocols, lab manuals, newsletters, operations manuals, etc.) to create comprehensive source documents that reflect the requirements of the study.
• Distribute source to applicable sites in a timely manner and work with site staff to revise source as needed.
• Develop templates of standard forms and logs in accordance with K2’s SOPs and workflows.
• Maintain version control of all published/finalized documents. Archive source document templates as applicable.
• Track the status of all source build requests, ensuring the final product is delivered on time. Assign priority to each request and manage multiple projects simultaneously.
• Revise source documents based on protocol amendments and new information. Clearly communicate the changes to site staff.
• Perform other assigned duties on as needed basis.
Knowledge, Skills, Abilities:
• Strong judgment, planning, and organizational skills. Self-motivated.
• Ability to manage multiple tasks/projects simultaneously.
• Familiar with medical terminology, GCP guidelines and FDA Regulations pertaining to clinical research and documentation best practices.
• Proficient with Microsoft Office,CRIO eSource, and Clinical Conductor CTMS.
• Learn and support the mission and goals of K2 Medical Research's program.
• Ability to communicate clearly/effectively (written and oral).
• Excellent interpersonal and customer services skills.
Qualifications:
• Bachelor’s Degree required.
• Minimum 2 years of clinical research experience with at least one year of patient care experience.
At K2, we value our employees and their professional and personal needs, and support these through our benefit offerings:
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