Location: Hamilton, NJ
Organization: Medavante-Prophase, Inc
Job Type: Full Time - Regular
Description and Requirements
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.
ABOUT US:
MedAvante-ProPhase, a member of the WIRB-Copernicus Group (WCG,) is a global provider of specialty solutions in clinical trials. Our goal is to optimize the selection, use, and analysis of behavioral endpoints to mitigate trial risk and maximize the likelihood of study success. Through collaboration and evidence-based innovation, we work to transform measurement science in clinical trials and improve outcomes for all stakeholders. Our services support all measurement-related activities in clinical trials and include eCOA and Endpoint Surveillance, Rater Qualification and Training, and Study Start-Up Support. By partnering with Sponsors, CROs and sites, and using a risk-based approach, we deliver services that are highly customized to study needs and adapted regionally for global trials.