Clinical Research Supervisor
Location: Weill Cornell Medical Center
Org Unit: Clinical Science Research
We are seeking a Clinical Research Supervisor to join our dynamic team studying the interactions between diet and cancer in the Division of Endocrinology and Department of Medicine. In this role, you will oversees and coordinate the daily activities of one of our physician-scientists and his research team. You will be responsible for managing the clinical research portfolio, and assisting the lab and PI with administrative duties. Also, you will have the opportunity to participate in special projects and task forces as determined by management.
Prepares, edits, submits, and manages several research protocols, primarily investigator initiative trials.
Coordinates clinical trials data management in compliance with federal regulations, GCP guidelines & internal policies. Ensures accurate & timely data compilation. Assists research team with facilitating enrollment, treatment & data collection of subjects.
Manages clinical research database via Excel or other application designed to support data capture for research studies (e.g. REDCap)
Generates study-specific tools to ensure protocol compliance.
Assists in screening of potential subjects; registers eligible subjects with the sponsoring agency accordingly.
Maintains complete research charts for assigned caseload of subjects. Completes all required case report forms and resolves all outstanding queries in timely manner.
Preparing, coordinating, and processing research lab kits as required
Assists in coordinating protocol schedule of events.
Reports all Adverse Events and Serious Adverse Events (SAEs) to Institutional Review Board and other agencies, as required.
Functions as liaison with sponsoring agencies. Coordinates site visits and audits of clinical trials in conjunction with all pertinent staff, including: the monitor/auditor, the regulatory office, investigational pharmacy, and investigators.
Maintains and disseminates accurate listing(s) of active and potential study subjects to participating investigators. Acts as a resource for detailed information on assigned protocols and other investigational research activities.
Performs other job related duties as required.
Obtains informed consent from patients who wish to participate
Acts as a resource for patients regarding study consent forms
Acts as a liaison between physicians and study participants including serving as a contact person for patients to call regarding questions regarding study protocol
Administers questionnaires or physical assessments to protocol subjects. Prepares mailings of follow-up questionnaires
Calls patients to follow-up with questionnaires and answer any questions
Oversees purchasing and time management
Monitors compliance with required laboratory training
Assists in producing and editing scientific grants, publications, abstracts and/or posters.
Maintains an inventory of supplies, equipment and/or reagents. May order supplies/equipment/reagents as authorized or ensure that needs are escalated appropriately. Receives supply orders and confirms accuracy of delivery. May assist with cost control.
Audits and screens vendors/suppliers to evaluate the quality of products and equipment they supply. Corresponds with them for technical support pertaining to those products.
Ensures that safe laboratory practices are followed including the use and disposal of chemicals and hazardous materials, no food/drink in the laboratory, and use of personal protective equipment.
Assists in the orientation and training of new investigators, students, fellows, residents, and technical staff and/or provide working supervision to lower level laboratory staff.
Catalogues receipts, packaging slips, and invoices within and between institutions.
Submits reimbursements for laboratory personnel
Schedules and organizes lab meetings and events
Sends and receives lab correspondence
Prepares and ships documents, supplies, equipment and/or reagents.
Coordinates calendars and schedules appointments and meetings. Prioritizes requests for meetings and coordinates the necessary arrangements for meetings. Manage Outlook email inbox of PI
Manages incoming phone calls for laboratory
Responsible for travel and conference arrangements. Organizes itinerary, makes appropriate reservations for travel and accommodations.
Records and distributes meeting minutes
Assists with responsibilities associated with professional organizations and external advisory boards and committees, which may include membership renewals, professional certifications, and journal renewals
Receives, sorts and distributes mail; accepts and signs for package deliveries.
Associates Degree in Science or closely related field or HS/GED plus two years of related experience. Degrees in the field of clinical medicine (MD, DO, VMD, DMD, DDS), nursing (NP, RN, BSN), physician assistant (PA), licensed practical nurse (LPN), or certified medical assistant are preferred.
Comprehensive knowledge and understanding of the regulations pertaining to human subject protection (including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations) and Health Insurance Portability and Accountability Act (HIPAA) is critical.
Knowledge of oncology-specific terminology is helpful.
Approximately 1 year of clinical trials experience preferred
Previous experience working in an academic medical environment preferred
Knowledge, Skills and Abilities
Demonstrated strong communication and interpersonal skills; demonstrated ability to interact with multiple constituencies
Excellent writing skills
Demonstrated proficiency with MS Office Suite and database applications
Demonstrated ability to multi-task and prioritize in a fast-paced environment
Demonstrated organizational skills and ability to pay close attention to detail
Ability to compose correspondence and to present information in a clear and concise manner to a diverse population at all levels
Demonstrated ability to exercise standards of professionalism, including appearance, presentation and demeanor
Effective at building formal and informal networks inside and outside the organization to further departmental and institutional goals.
Adept at building partnerships and working collaboratively with others to meet shared objectives and goals.
A good decision-maker, with shown success at making timely decisions that keep the organization moving forward.
Eager to foster talent and support people in meeting their career goals and the organization's goals.
To apply, please send a cover letter with a brief summary of research experience and interests, resume/CV, and the contact information for 3 referees to Dr. Goncalves (firstname.lastname@example.org).
Applicant must be available for interview in New York.