Clinical Research Monitoring (CRA)

Clinical Research Assistant

Research -- Support Staff

New York, NY Temporary

NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. At NYU Langone Health, equity and inclusion are fundamental values. We strive to be a place where our exceptionally talented faculty, staff, and students of all identities can thrive. We embrace inclusion and individual skills, ideas, and knowledge.

We have an exciting opportunity to join our team as a Clinical Research Assistant. Position Summary: Responsible for providing direct data and/or clinical research in support of clinical trials, studies and general research under direct supervision. Works with School of Medicine and Medical Center staff and departments, including Directors, Managers, Clinical Information Systems, Research Nursing and Regulatory Services; Utilizes the necessary tools to ensure protocol compliance to conduct direct data research.

Reviews data with supervisor and provides reports to the data and safety monitoring committee.

Tracks study milestones and patient accruals to help evaluate the progress of studies.

Demonstrates knowledge of and follows proper clinical study processes within current policies and procedures.

Works with research nurses as part of a team to coordinate clinical trials.

Works with the principal investigators and research nurses on monitoring the overall conduct of the study.

Monitor any outward effects or issues regarding patient/subject safety and report this to the Principal Investigator, Physician and Research Nurse.

Conduct study visits, obtain and document information within the time frame specified.

Demonstrate knowledge of policies and procedures of the host institution where the study is being conducted and the regulatory requirements such as IRB and other approvals if necessary.

Thorough knowledge of research study, study rationale, study subject, and clinical procedures associated with the study.

Liaisons with monitors during site visits, providing them with assistance specific to the monitoring visit.

encourages visit reminders and compliance to research; Interfaces with varied persons, such as, School of Medicine and or Medical Center staff (e.g. physicians, nurses, CTO).

May be required to travel to study initiation (that is, where sponsor teaches protocol to PI and CRC).

Draw patients/subjects blood, perform EKG, and or take vital signs (if proper training has occurred)

Complete assessments on study subjects/patients per protocol (with proper training); continue to follow-through with items and patients as part of research study.

Attends appropriate trainings in the proper handling and collection of biological substances and the packaging and shipment of samples as well as required IRB and HIPAA tutorial.

Collects, prepares, ships, and/or stores biological materials using universal precautions.

Follow-ups to ensure that requested materials are delivered according to all appropriate procedures and policies.

Utilizes established methodologies to collect patient information for the research project(s).

May request articles from medical journals.

May perform library searches and retrieve reference materials from various sources using Medline and PubMed.

Ensures that information in computer database is accurate, entered and maintained on a timely basis.

Prepares requested data and numbers thoroughly and accurately for statistical analyses and required reporting.

Reviews data to be entered, edits obvious errors and obtains missing information.

Completes paperwork and forms in a neat, accurate, timely manner and ensure subsequent data collection as required.

Processes incoming and outgoing documents by transcribing data, figures, statistics, codes and other information.

Suggests changes and additions to established data fields as needed, to supervisor.

Inputs clinical and non-clinical data into the database and or case report forms; ensures data entered is correct and consistent with the source document and completed in a timely and organized manner.

Utilizes appropriate sources, gathers and compiles data, statistics and other materials as needed.

Reviews data with supervisor and then provides reports to all parties (e.g., data and safety monitoring committee, the principal investigator, sponsoring agency, etc.) Reviews any issues that deviate from standard policy and procedure with supervisor.

Compiles data and assists in consolidating and analyzing data for presentation to sponsoring and regulatory agencies.

Secures accurate signatures and forwards documents and or forms to the appropriate destination based on prescribed policies and procedures.

Formats and uses tools to facilitate data collection (e.g., Completes report forms and records following set protocol from the beginning of a research/study through the end.

Extracts data for publications, or provides data collection from outside physicians offices.

Secure accurate signatures and forward documents and/or forms to appropriate destination.

Works with departments, labs, other personnel and areas as needed, to ensure the timely transfer of items and biological materials: study drugs; histology slides; serum, urine, blood samples, etc., Coordinates the shipment and transfer of varied types of materials among the various departments and labs.

Gathers, Properly Packages, Stores and Transfers Slides, Samples and Other Important Materials.

Duplicates and collates materials upon request.

Record IRB approved subject study reimbursements according to standard operating procedures.

Provide material for and/or initiate IRB correspondence.

Record, update, edit and maintain confidential information onto paperwork or web-based forms in a neat, accurate and timely manner and ensure subsequent data collection as required.

Maintain complete, accurate subject charts, case report forms, enrollment logs, and hospital records.

Aware of study regulatory status and keep an up to date copy of regulatory documents.

Computer literate with good interpersonal, writing and verbal communication skills.

NYU Grossman School of Medicine provides its staff with far more than just a place to work. At NYU Langone Health, we are committed to supporting our workforce and their loved ones

NYU Langone Health