REMOTE CONTRACT POSITION
The ideal candidate would be an entry level CRA or study coordinator with at least 2-3 years of experience in a clinical environment or pharma.
To support AbbVie' s role as a world class R&D organization, this position will be accountable for supporting patient, caregiver and HCP experience in clinical trials. As a member of the Trials Awareness and Access (TAA) team, the project coordinator reports to both the Director and Senior Manager of TAA. The TAA team is responsible for the ongoing development and maintenance of the Global Clinical Trials and Me website, collaboration with MPO_UCC, Global Medical Communications and opportunities for internal and external awareness of AbbVie Clinical Trials.
External Communication MPO_UCC, Global Medical Communications
Accountable for appropriately triaging incoming patient, caregiver, HCP requests for information as received from cross functional partners in MPO_UCC and Global Medical Communications.
Uses internal and external systems to identify correct information and the appropriate messaging to be provided to MPO_UCC and Global Medical Communications in order to respond to inquiries within 48 hours.
Maintains the database of inquiries; creates and distributes monthly, quarterly and annual metrics and reports to TAA leadership.
Monitors and reports issues that require escalation to the Director and Senior Manager for immediate resolution.
Identifies trends and provides feedback on interactions that may require attention in ad hoc or monthly or quarterly reports.
Clinical Trials and Me (CTaM)
Creates and maintains TAA work plans and monitors project implementation in collaboration with the AEM project manager and the CTaM vendor partner(s).
Maintains the tracking of project status, global affiliate contacts, and documentation for recertification and compliance as directed. Examples of trackers include but are not limited to SOW execution, action item status, and various trackers (Pre-Qualify Button, Content etc.)
Gathers, prepares and submits documentation for approval and regulatory submission as directed.
Updates and maintains Global metrics related to the performance and health of the website and updates slides accordingly.
Prepares weekly meeting agendas and minutes and distributes them same day.
Tracks AEM, BSG and other internal cross functional teams monthly and special project spend and provides monthly data to TAA leadership team.
Supports eTMF inspection readiness by maintaining, distributing and archiving all minutes, reports, and program documentation in the appropriate system (SharePoint and/or eTMF) as directed by TAA leadership.
Performs trial master file (eTMF) reconciliation and filing for CTaM, SharePoint updates and systems reconciliation and alignment under the supervision of TAA leadership.
Bachelor's Degree in a scientific field preferred
Minimum of 2 years + of pharma-related/clinical research experience (and/or applicable work experience)
Strong project management skills and ability to multi-task across team projects
Good communication and presentation skills (oral and written). Collaborative skills in a cross-functional global team
Competent in use of electronic systems
Competent knowledge of clinical documentation business procedures
Proven critical thinking and organizational skills
Working knowledge of ICH and GCP guidelines is required.
Experis is an Equal Opportunity Employer (EOE/AA)
Trial Master File
Clinical Research Associate
Good Clinical Practices (Gcp)