The Project Coordinator II acts as a liaison between external site staff and internal Project Managers by acting as the initial point of contact for sites on projects involving site management activities, according to MA-PP SOPs and GCP. The successful incumbent provides quality customer service and assures that site management activities are performed and delivered on time and according to client expectations.
EDUCATION REQUIREMENTS:
• Bachelor’s degree life science required, or certification in a related allied health profession from
an appropriately accredited institution and clinical trial experience. (e.g., nursing certification,
medical or laboratory technology).
QUALIFICATIONS/EXPERIENCE:
• Minimum of 3 years’ clinical trial experience required or related experience and/or training in a clinical services environment required.
• Ability to work in a fast-paced environment and support multiple projects concurrently and able to manage a variety of tasks.
• Proven track record of successfully collaborating on projects and taking initiative.
• Good planning, organization, detail oriented and problem-solving abilities.
• Experience working directly with sponsors and sites. Experience working with psychiatric (e.g. depressions, anxiety) indications preferred.
• Thorough understanding of the clinical trial process and good clinical practices (GCP).
• Knowledge of IRB regulations and submissions (informed consent, etc.) required.
• Must be proficient in native language of Hub Office and/or English. Multi-lingual a plus.
• Must have exceptional customer service skills.
• Effective communication, oral, and writing skills are required.
• Experience with trial management tools/systems preferred. Experience with Salesforce a plus.
ESSENTIAL DUTIES/RESPONSIBILITIES:
• Act as Initial point of contact for investigative site inquiries regarding MA-PP study specific projects.
• Recommends solutions to streamline the efficiencies of internal department processes. Independently investigates, resolves or escalates issues to the appropriate internal team members.
• Collaborates with internal departments, such as Project Management, IT and Clinical Trial Services to create internal Site Management working documents (i.e. project specific addendums) and external site/client facing documents (i.e. site manuals).
• Update, track, and maintain study-specific trial management tools / systems. Set-up and maintain study files (study specific, investigator, etc.).
• Conducts MA-PP site management activities, including site activation, site training and issue resolution, ensuring highest customer satisfaction.
• Guides site raters through MA-PP training process from initial rater qualification to training completion.
• Serves as subject matter expert on internal systems and works with MA-PP clinicians on rater training and qualification for investigative sites and project activities (this may include but is not limited to managing site rater training or assessment activities.).
• Provides exceptional and timely external customer support by determining requirements, answering inquiries, researching and exploring issues to resolution, escalating the issues as needed, and maintaining internal issue management application.