Job: Clinical Research Project Associate
Work Location: Midtown
Organization: Joint Clinical Trials Office
Work Days:
Sponsorship Eligibility: [[custSponsored]]
Classification: [[custFTEclassification]]
Posting End Date: [[cust_PostingEndDate]]
Position Summary
The Clinical Research Project Associate oversees all aspects of study coordination and study conduct for multisite investigator-initiated studies with a focus on large, pragmatic clinical trials. This key role will serve as the expert in project operations including study design, study conduct, data management, and quality assurance.
Job Responsibilities
- Aligns w/ key stakeholders both internal & external to manage all study coordination & conduct activities for multisite investigator-initiated studies, in accordance w/relevant regulations, Standard Operating Procedures (SOP), & study specific procedures.
- Serves as the primary contact for external subsites on all project related operational matters.
- Collaborates with WCM Principal Investigator (PI) on project design and development of study protocol and informed consent form (ICF).
- Completes all WCM regulatory submissions including Protocol Review and Monitoring Committee (PRMC), Institutional Review Board (IRB), Data Safety Monitoring Committee (DSMC), and other regulatory agencies as required.
- Coordinates with Clinical Research Subsite Navigators to ensure timely dissemination of new and revised project documents to participating subsites.
- Creates the electronic data capture (EDC) system in collaboration with the developers on protocol-specific database design. Ensures the user interface is intuitive for study team use.
- Generates subsite data completion metrics for distribution to subsite PIs and study teams.
- Develops and implements a project-specific monitoring plan. Performs remote monitoring visits to review data timeliness and accuracy. Issues queries for missing data elements or those requiring follow-up.
- Ensures timely resolution of pending data entry and queries.
- Plans subsite Site Initiation Visits (SIV). Develops presentations, training, and educational materials to ensure successful subsite start up. Provides ongoing training and subsite study team support throughout the course of the project.
- Prepares and presents study metrics, progress, and long-term goals at Steering Committee meetings. Leads project-specific study coordinator meetings.
- Provides ongoing updates and reporting to subsite study teams, WCM PI and internal collaborators. Streamlines and facilitates communications with subsites.
- Performs other related duties as assigned.
Experience
Approximately 3 or more years of related research experience in clinical trial management.
Knowledge, Skills and Abilities
- Knowledge of FDA regulations, IRB requirements, Good Clinical Practice, and clinical research databases.
Licenses and Certifications
Working Conditions/Physical Demands
Weill Cornell Medicine-Qatar was established in 2001 as a partnership between Cornell University and Qatar Foundation (QF). The first medical school in Qatar and a pioneer of coeducation at the university level, WCM-Q offers an integrated Six-Year Medical Program that incorporates pre-medical and medical studies and leads to the Cornell University M.D. degree.
Teaching is by Cornell and Weill Cornell faculty, including physicians at Hamad Medical Corporation (HMC) who hold Weill Cornell appointments. Enrollment has grown rapidly from 25 first-year pre-medical students in the fall of 2002 to over 300 students from more than 30 countries today.
WCM-Q is part of Weill Cornell Medicine in New York City, which was founded over 100 years ago, and shares the same mission:
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to provide the finest education possible for medical students
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to conduct research at the cutting edge of knowledge
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to improve healthcare both now and for future generations
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to provide the highest quality of care to the community
WCM-Q’s home city is Doha, a thriving cosmopolitan metropolis with a culturally diverse population, a rapidly growing economy, and modern infrastructure. WCM-Q is a member of Qatar Foundation, a not-for-profit organization with multiple centers focused on education, research and innovation, and community development. WCM-Q is located within Education City, the flagship development of QF, which occupies more than 12 square kilometers and is home to some of the world’s leading educational institutions, including Hamad Bin Khalifa University, and overseas campuses of elite universities, such as VCUarts Qatar, Texas A&M University at Qatar, Northwestern Qatar, Georgetown University in Qatar, Carnegie Mellon University in Qatar, and HEC Paris in Qatar.
Weill Cornell Medicine-Qatar is an Equal Employment Opportunity/Minorities/Females/Vet employer.
