Clinical Research Associate I-Psychiatry

Description The Clinical Research Associate I monitors all aspects of clinical research trial(s) Clinical study life-cycle responsibilities including site management, ongoing maintenance and closure of pre‑clinical, Phase I through Phase IV, and post‑marketing studies. Responsibilities 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 CTM, 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 CTM. Works with the CTM 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 (ISF). 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. Assists the CTM with tracking and requesting grant payments, and maintains study budget. Tracks and reports all adverse events, protocol deviations, and any other unusual activity experienced by assigned investigator sites and communicates with 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 CTM. Prepares documentation for and attends Clinical Event Committee (CEC) meetings, if applicable. 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. Assists in preparing clinical reports of assigned projects for submission to regulatory authorities. Performs other duties as required. Qualifications Bachelors Degree in life sciences or BSN. 1-2 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. Compensation The Mount Sinai Health System (MSHS) provides salary ranges that comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $58661 - $81675 Annually. Actual salaries depend on a variety of factors, including experience, education, and operational need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits. Equal Opportunity Employer The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization. #J-18808-Ljbffr