Strength Through Diversity

Ground breaking science. Advancing medicine. Healing made personal.

The candidate will be an integral member of the Clinical Protocol & Data Management (CPDM) Office within the Tisch Cancer Institute. The candidate is responsible for providing managerial oversight for TCI sponsored multicenter trials including protocol and ICF development, site activations, data management, regulatory processing, auditing/monitoring, tracking specimen collection, data analysis and publication. Assist in the development of multicenter clinical trial budgets, sub-site invoicing/payments and research fund accounting. Help facilitate multicenter trials confidentiality disclosure agreements and clinical trial contracts. The candidate is responsible for implementing policies and procedures that improve and stimulate the work environment, which is a key aspect of this position. The candidate is responsible for assessing workloads, competently, and assigning projects appropriately to ensure positive outcomes. The candidate must recognize and identify opportunities for continued improvement and operational efficiencies. In addition, the reputation of the institution relies on the quality of the clinical research team; this reputation in turn ensures continued positive relationships with private industry and other external agencies.

Manage the day-to-day operations, including regulatory, study start up, IP delivery, data management, onsite and remote monitoring and other administrative functions including weekly conference calls, for these the multi-institutional trials.

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, 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. May work 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, 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 with budget and payments.
• 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 required meetings, participates in adjudication meetings, documents results, assists in entering of adjudication data and dissemination of results 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.

Requirements:

Education:

• Bachelor’s Degree, in Science or closely related field; Master’s Degree preferred.

Experience:

• Minimum 5 years experience in clinical research setting, preferably with specific experience managing multicenter investigator-initiated trials and participation in QA audits.
• Expertise knowledge in Phase I-IV clinical studies
• Experience with regulatory and data management aspects of clinical research.
• Experience with budgeting and billing compliance aspects of clinical research.

Skills & Abilities:

• Proficiency in MS Office, specifically word processing (Word), spreadsheets (Excel) and database applications.
• Excellent organizational, oral and written communication skills.
• Ability to foster smooth communications and teamwork among clinical research faculty, fellows and staff as well as external sites and organizations (sponsors and contract research organizations).

Strength Through Diversity

The Mount Sinai Health System believes that diversity, equity and inclusion are drivers 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 medicine together and participate actively as a leader within the Mount Sinai Health System by:

• Serving as the primary resource management representative of the Mount Sinai leadership teams, committees, etc., and acting as the primary executive leader interface between Mount Sinai and key executives from the health systems’ vendors and partners.
• Engaging with relevant thought leaders and policy-makers at the federal and state levels, and representing the Health System as assigned.
• Using a lens of equity in establishing and promoting policies and procedures and providing opportunities for all to thrive.
• Confronting racist, sexist or other inappropriate behavior and challenges exclusionary organizational practices and serving as a role model to promote anti-racist behaviors.
• Inspiring and fostering an environment of anti-racist behaviors among and between departments and co-workers.

We work hard to acquire and retain the best people, and to create a welcoming, nurturing work environment where you can develop professionally. We share the belief that all employees, regardless of job title or expertise, can make an impact on quality patient care.

Explore more about this opportunity and how you can help us write a new chapter in our story!

Who We Are

Over 42,000 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 hospital campuses, including Mount Sinai Beth Israel, Mount Sinai Beth Israel Brooklyn, The Mount Sinai Hospital, Mount Sinai Queens, Mount Sinai West (formerly Mount Sinai Roosevelt), Mount Sinai Morningside (formerly 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 comply with applicable Federal civil rights laws and does not discriminate, exclude, or treat people differently on the basis of race, color, national origin, age, religion, disability, sex, sexual orientation, gender identity, or gender expression.

EOE Minorities/Women/Disabled/Veterans

Compensation

The Mount Sinai Health System (MSHS) provides a salary range to comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $65,885.00 - $98,827.00 Annually. Actual salaries depend on a variety of factors, including experience, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.