Ground breaking science. Advancing medicine. Healing made personal.
The Senior Clinical Research Associate manages all aspects of clinical research trial(s) coordination including activities involved in the planning, conduct and completion of a clinical trial(s) at multiple sites. Depending on the department and clinical trial there may be significant travel time required.
Roles & Responsibilities:
- Leads the coordination of the clinical trial(s).Clinical study life-cycle responsibilities include involvement in the selection of sites, management of the training of study site personnel (including investigators and coordinators), planning and oversight of national study meetings, and management/coordination of the day-to-day operational activities associated with conducting and closing out Phase I through Phase IV, and post-marketing studies
- Assists in the recruitment strategies and enrollment tracking, data analyses and manuscript preparation
- Prepares and completes critical study documents and performs final editing/proofing prior to release of document (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.)
- Contributes to the development of Standard Operating Procedures (SOPs), work practices, and clinical guidelines
- Establishes timeline and target dates for completion of study milestones in collaboration with trial leadership. Utilizes data reports and site metrics to deliver milestones on time and budget
- In collaboration with team members, monitors clinical trial sites, all clinical studies, and the documentation of all findings, outcomes, and agreements
- Assures all clinical site trial documentation is maintained in compliance with all applicable guidelines and corresponding procedures documents
- Participates, with the CTM/CRM, 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/CRM
- May work with the CTM/CRM 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, distributes, collects and archives all study related correspondence to the investigator clinical sites 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
- May track and request grant payments, and maintain study budget, or assist the CTM/CRM with budget and payments
- May 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
- May review all adverse events reported in clinical study for the identification and evaluation of safety issues and any patterns that are identifiable
- May reports safety findings in a summary format to the CTM/CRM
- Prepares documentation for and attends required meetings, participates in adjudication meetings, documents results, assists in entering of adjudication data and dissemination of reluts to clinical sites, 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
- Prepares clinical reports of assigned projects for submission to regulatory authorities
- Performs other duties as required
- Education: Bachelor’s Degree in life sciences OR B.S.N. Nursing degree
- Experience: Minimum 4 years of experience in Phase I-IV clinical studies as a clinical research associate
- 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
Strength Through Diversity
The Mount Sinai Health System believes that diversity and inclusion is a driver for excellence. We share a common devotion to delivering exceptional patient care. Yet we’re as diverse as the city we call home- culturally, ethically, in outlook and lifestyle. When you join us, you become a part of Mount Sinai’s unrivaled record of achievement, education and advancement as we revolutionize healthcare delivery together.
We work hard to recruit and retain the best people, and to create a welcoming, nurturing work environment where you have the opportunity and support to develop professionally. We share the belief that all employees, regardless of job title or expertise, have an impact on quality patient care.
Explore more about this opportunity and how you can help us write a new chapter in our story!
Over 38,000 employees strong, the mission of the Mount Sinai Health System is to provide compassionate patient care with seamless coordination and to advance medicine through unrivaled education, research, and outreach in the many diverse communities we serve.
Formed in September 2013, The Mount Sinai Health System combines the excellence of the Icahn School of Medicine at Mount Sinai with seven premier hospitals, including Mount Sinai Beth Israel, Mount Sinai Brooklyn, The Mount Sinai Hospital, Mount Sinai Queens, Mount Sinai West (formerly Mount Sinai Roosevelt), Mount Sinai St. Luke’s, and New York Eye and Ear Infirmary of Mount Sinai.
The Mount Sinai Health System is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, background, or sexual orientation.