Details
Posted: 19-Jun-22
Location: Nationwide
Salary: Open
Categories:
Academic / Research
Company Overview
At Memorial Sloan Kettering (MSK), we're not only changing the way we treat cancer, but also the way the world thinks about it. By working together and pushing forward with innovation and discovery, we're driving excellence and improving outcomes. We're treating cancer, one patient at a time. Join us and make a difference every day.
In compliance with applicable New York and New Jersey State regulatory authorities, COVID-19 vaccination (2 doses of either the Pfizer or Moderna vaccine or one dose of the Johnson & Johnson vaccine) is mandatory for all MSK employees, contingent workers, and volunteers. Exceptions are permitted for those employees who request and receive an approved medical or fully remote exemption.
*Staff working at a MSK New Jersey location must be up to date with COVID-19 vaccination, which includes having completed the primary COVID-19 vaccination series and booster once eligible as mandated by New Jersey State. All New Jersey staff not yet eligible for a booster must receive a booster within 3 weeks of becoming eligible as a condition of continued employment at MSK.
Note: Individuals are eligible to receive a COVID-19 booster five months after receiving the second dose of either the Pfizer or Moderna vaccine or two months after the J&J vaccine.
Job Description
We have an exciting opportunity to join our dynamic team in our Melanoma Service, Department of Medicine as a Clinical Research Manager (CRM) in a remote/hybrid capacity.
The Melanoma Service is an international leader in melanoma and immunotherapy research. Clinical trials led by the Melanoma Service have resulted in several FDA approved drugs, and we now are seeking a CRM to lead ongoing research programs that build on our prior success. Specifically, we are interested in ongoing questions such as: why immunotherapy works for some patients but not all; how brain metastases can be better treated with new combinations of immunotherapies; how new imaging tools can be used to better visualize the immune system during treatment; and what new drugs may work when standard treatments have failed. We expect our research findings will not only help patients with melanoma but will also improve the lives of patients with other cancers treated with immunotherapy. Most importantly, we are a fun group and want to see what exciting ideas you have for our team!
The Clinical Research Manager role within the Melanoma Service provides a unique opportunity to work closely with key faculty stakeholders in the strategic growth of the service. In our group, we aim to provide the highest quality patient-centric care, data management, clinic management, and regulatory compliance on all clinical trials and research projects.
As a CRM, you will be responsible for the following:
- Clinical Research Operations Leadership: Provides leadership, strategic direction, and oversight of the Melanoma Service including all protocols and research projects. Partners with leadership to strategically forecast operational needs and sets the long-term direction of the program.
- Quality Assurance: Participate and ensure preparedness in routine audits for data quality, regulatory compliance, patient safety issues related to clinical trial. Ensures compliance with policies and procedures, quality and safety standards, improvement initiatives, and external regulations.
- Staff Management: Supervise and coordinate the day-to-day activities of 6-9 staff members within the service including Clinical Research Coordinators (CRCs), Clinical Research Associates (CRAs), Clinical Research Specialists, Research Regulatory Associates, and Research Project Associates to ensure efficient and effective operations.
- Financial Management: Work closely with the appropriate partners, forecast trial resource needs, and assess staffing resource needs for program and senior leadership.
- Regulatory Compliance and Oversight: Ensures that all appropriate Institutional, State, and Federal regulations are followed throughout the course of a research project, database, or protocol. Ensures that research protocols are approved by the Institutional Review Board and followed as written.
- Special Projects: Participates and/or coordinates departmental and/or organization-wide research projects. Provides leadership, organizational, creative, or clerical support to both established and new research initiatives.
You Are:
- Proactive and motivated to take correct actions to advance our mission through your own experienced judgment and informed analysis.
- 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 projects on deadline.
- Detailed oriented and able to multi task.
- Able to manage competing priorities.
- Eager to foster talent and mentor staff in their current roles and develop them so that they can attain the next steps in their career.
You Have:
- 4 years of clinical research experience preferred.
- 2+ years of staff management experience preferred.
- Thorough knowledge of Good Clinical Practice (GCP) guidelines, Human Subject Protection, clinical trial design, regulatory processes, and clinical development process required.
- Effective written/verbal communication and oral presentation skills required. Excellent interpersonal, leadership, decision-making and issue resolution skills are essential.
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MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.
Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.