Database and Biospecimen Transfer Management Oversight
Oversee creation and SOP management of several large, big data databases, REDCaps,
LabVantage, Big Purple, biospecimen/biorepository tracking systems and entry for all studies,
ensuring accurate and timely input, as well as organized and clean data/specimen quality
Oversee shipping and delivery (logistics, coordination, contracts, etc.) for the secure and safe
shipping and transfer of large biospecimens, as well as their safe storage in accordance with
developed guidelines and established SOPs.
Lead and coordinate the complex transfer of database files and data points between multiple
institutions, technicians, and biostatisticians upon request and for interim analysis under the
guidance regulatory compliance and contracted language.
Ensure contractual and protocol compliance: standard steps regarding safety and security as
well as integrity of data/biospecimens are adhered and required documentation consistently
followed in the time frame specified.
Review and audit data entered by study personnel
Administration, Analysis, Reporting, and Compliance
Prepare and submit of reports (annual, progress, financial, safety etc.) to regulatory agencies,
federal & state oversight organizations, data & safety monitoring boards and study sponsors.
Create and maintain study records within all portals of Research Navigator (My Studies, IRB,
CRMS, My Agreements, etc.) and Regulatory Binders. Prepare submissions as necessary.
Maintain FDA INDs held by the PI/Investigators.
Prepare and submit of applications for PI/Investigators DEA and BNE Licensure &
Assist in protocol development & grant writing as needed.
Establish and follow Standard Operating Procedures to ensure adherence to trial protocols and
Ensure study team personnel adherence to Good Clinical Practice and compliance with
NYUSoM and external regulatory agencies.
Oversee Quality Assurance activities.
Facilitate agreements in collaboration with SPA as necessary (Consulting, Data Sharing,
Biospecimen transfer, etc.).
Clinical Research Duties
Act as primary point of contact for all trials and manage day-to-day communication and
activities of the clinical trial team.
Meet regularly with the PI to review and monitor the overall conduct of the study.
Utilize available resources and established procedures in order to rectify problems and
communicate all changes.
Prepare internal and external memos, source document and case report form templates,
reports, and correspondence required to properly manage and document activities on the studies.
Coordinate study-drug shipment, accountability and compounding.
Handle, collect, prepare, transport and ship biological specimens as required by study
Schedule and coordinate study visits as needed
Conduct study visits with Research Staff and PI, collect data as required – particularly needed
clinical measures, such as SCIDs, CAPS, etc.
Mentor junior staff, student interns, and volunteer study staff throughout the course of all
Oversee MyTime time management system for study team members.
Coordinate promotions and new hire requisitions as needed under the supervision and
guidance of the Sr. Project Manager
Onboard and supervise junior staff as needed.
Work to PI to facilitate study team cohesion and collaboration.
Delegate to junior staff and volunteers as necessary.
Recruitment & Retention
Establish and cultivate relationships with NYU clinical staff including physicians, NPs, social
workers, etc. in efforts to recruit patients and maintain positive affiliation.
Lead the ongoing recruitment efforts at Tisch Hospital, Bellevue Hospital Center and outside
sources to ensure subject accrual goals.
Create and place advertisements in various media platforms so as to expand recruitment
efforts to the general population who may be interested in potentially participating in respective
Initiate and schedule meetings/presentations/outreach activities between the study staff and
medical center staff and treatment demographic population.
Obtain informed consent, assess for eligibility and coordinate subsequent study visits with
Maintain study-specific logs with regards to NYUSOM IRB, NYS and Federal regulations.
Expense Management and Finance Control
Ensure accuracy and timeliness of study consultant and vendor payments as well as study
subject reimbursement and compensation payments.
Oversee study materials and supplies & monitoring quantities. Initiates ordering or new
supplies with reference to study budgets when necessary.
Work directly with the Sr. Research Project Manager, PI, Department administrator, program
manager, and sponsors to ensure open and accurate communication regarding the study funds.
Ability to read and comprehend sponsors’ budget