Clinical Trials Administrator-CCTO

Weill Cornell Medical College•New York, NY

1d•Onsite

About The Position

Responsible for the day-to-day management of the clinical research and related activities for specified programs and/or disease area(s).

Requirements

Bachelor's Degree (Significant experience may be considered in lieu of a degree).
5+ years of experience in clinical research setting with exposure to a team research environment at all levels.
Experience with regulatory, data management, and billing compliance aspects of clinical research.
Experience with conducting and carrying out protocols and research coordination.
Demonstrated leadership and mentoring skills to effectively manage and develop staff members.
Knowledge in Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations, and International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines.
Excellent written and verbal communication skills.
Demonstrated strong communication and interpersonal skills; demonstrated ability to interact with multiple constituencies and exercise "people skills".
Demonstrated proficiency with MS Office Suite and database applications.
Demonstrated organizational skills and ability to pay close attention to detail.
Demonstrated critical thinking and analytical skills.
Demonstrated ability to multi-task and prioritize in a fast-paced environment.
Demonstrated ability to remain focused despite frequent interruptions.
Ability to treat confidential information with utmost discretion.
Demonstrated ability to exercise standards of professionalism, including appearance, presentation and demeanor.
Demonstrated ability to work effectively in a collaborative manner with all departmental faculty and staff, as well as other institutional representatives.
Ability to work independently and as part of a team within a fast-paced working environment.

Nice To Haves

Prior management/supervisory experience a plus.
Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) certification preferred.

Responsibilities

Serves as central point person for program related matters and issues.
Provides guidance on research-related questions within the program.
Troubleshoots potential issues and facilitates smooth clinical study operations among research team.
Recruits, trains, and supervises study coordinators and research assistants to ensure efficient and effective operations.
Responsible for the operational oversight of all clinical research studies within the program area to ensure compliance with regulations, SOPs, and protocol.
Assists the Assistant Director with tracking and prioritization of research portfolio.
Manages logistical and operational issues related to study start up and closeout, including non-regulatory related submissions.
In collaboration with the Assistant Director, conducts workload assessments to determine staffing levels.
Oversees data timeliness and quality.
Performs QA reviews in EDC and subject research records, including OnCore.
Ensures compliance with internal/external audits, inspections and monitoring reports.
Assists with development and implementation of corrective action plans to address deficiencies as necessary.
May serve as liaison to audit team(s) during on-site visits.
Oversees reconciliation of research charges, invoiceables, and subject financial trackers for assigned services.
Responsible for dissemination of research-related billing information and policies to clinical trials staff and investigator.
Performs other job related duties as required.