Strength Through Diversity
Ground breaking science. Advancing medicine. Healing made personal.
Dept- 015 Tisch Cancer Institute REQ #2471492
Job Title: Clinical Research Associate I
- Prepares and completes critical study documents and performs final editing/proofing prior to publishing (e.g. protocol; synopsis; flowchart; informed consent template; investigator brochure; monitoring guideline; statement of work laboratory, other vendors, and CROs; consultant agreements; investigative device/drug labels; clinical study worksheets; etc.).
- Monitors resources/reports to deliver milestones on time and budget.
- Collect, reviews and files all clinical study documentation for assigned trial(s) and investigative sites and maintenance of clinical trial master file (CTMF): assures all documentation is maintained in compliance with all applicable guidelines and corresponding SOPs.
- Participates, with the BMT Management, in the preparation and hosting of clinical study team meetings on an established schedule, providing agenda, recording/distributing of minutes and copying of minutes to BMT Management.
- Works with BMT Management to prepare and compile materials for clinical study conduct and reference information for study sites provided to the site in the form of an investigator site file (!SF).
- Prepares, collects and archives all study related correspondence to the investigator site including, but not limited to, newsletters, “Dear Dr.” letters, FDA/HA correspondence, contractual agreements and others.
- Responsible for investigator recruitment and maintaining current contact information for each assigned investigator site, as well as preparing investigator site file for participation approval.
- Collects pre-study documentation and essential regulatory documents from assigned investigator sites, as well, as collects updated documents prior to study initiation and on an ongoing basis.
- Estimates, orders, and coordinates shipments of clinical study supplies to assigned investigator sites.
- Tracks and reports all adverse events, protocol deviations, and any other unusual activity experienced by assigned sites on routine matters.
- Reviews all adverse events reported in clinical study for the identification and evaluation of safety issues and any patterns that are identifiable.
- Reports safety findings in a summary format to the BMT Management.
- Identifies and documents data errors or items requiring clarification on all documents collected for study and initiates data clarification/validation process after researching source documents.
- Performs other duties as required.
- Minimum Required Education: Bachelor’s Degree; Bachelor’s Degree in science related field preferred.
- A minimum of 2 years experience in relevant Clinical Research. Experience in Phase I-IV clinical studies as a clinical trial assistant or clinical research associate is highly desirable. Excellent Communication and writing skills, professionalism and ability to effectively interact with staff and management alike; ability to verbally communicate effectively with management, department clinical research and other team members.
- CCRP / CCRC Preferred, CITI & GCP Required
- Application: Outlook, Word, Excel, Power Point – Skill Level: Intermediate
- Oncology experience, some Regulatory knowledge
- General Office Environment