Specialist, Lead Clinical Trial Protocol Development - (200000FW)
The University of Maryland, Baltimore (UMB) School of Medicine, Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is seeking a full-time Lead Clinical Trial Protocol Development Specialist . This top-ranked nationally recognized Comprehensive Cancer Center has made significant strides in expanding basic and clinical research to include a strong population science program to help reduce disparities in cancer treatment and has a strong focus on new therapies in both an inpatient and outpatient setting. The Lead Clinical Trial Protocol Development Specialist will join the team of committed staff and investigators to further the development of new cancer therapies.
This lead position will be directly involved in the development and implementation of investigator-initiated clinical trial protocols and for providing regulatory oversight for clinical trials for investigators at UMGCCC. The incumbent works with University faculty and staff, local and federal oversight agencies, and industry and/or government funding agencies to ensure accurate progress of clinical trials from the planning stage through study completion.
UMB offers a comprehensive and competitive benefits package to eligible employees. This position receives an annual leave package starting with 22 accrued vacation days, 14 floating and observed holidays, 15 sick days, and 3 personal days; comprehensive health insurance and retirement options; professional learning and development opportunities; flexible schedules and teleworking options; and tuition remission for employees and their dependents at any of the University System of Maryland schools.
Responsible for aiding in the development of: investigator initiated studies, ensuring compliance with cancer center and IRB requirements; documentation, (e.g. IRB documents, informed consent documents, single patient IND, Emergency use, expanded access, and IDE applications); training of staff for implementation of research protocols using a variety of complex activities.
Networks with faculty and staff to achieve strategic goals and maximize efficiency. Collaborates with supervisor and other members of the organization to develop and implement policies and procedures related to the development and implementation of investigator-initiated clinical trials.
Coordinates developing and recommending Case Report Forms, policies, and procedures and/or design methods for investigator initiated clinical research protocols.
Assists in the development and implementation of Site Initiation Visit materials and tracking tools to comply with data monitoring requirements per federal regulations and guidance.
Collaborates with Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trial.
Maintains communication with colleagues regarding protocol specific information.
May develop data collection instruments such as survey questionnaires.
Develops, recommends, modifies, and implements policies and procedures and/or methods of clinical research to meet changing needs and requirements and enforces standards.
Assists in the development and collection of essential regulatory documents to comply with data requirements per federal, institutional and state guidelines. May assist in the analysis of research data in order to prepare research findings for publications of journal articles and grant proposals.
Manages communications with the IRB, FDA and Clinical Trials.gov postings.
Serves as liaison to other departments such as IRB, IBC, RSC, and CCT, outside organizations, government agencies, and product representatives.
Trains and provides mentoring to other research personnel in implementation of research protocols, IRB submissions, research procedures and policies, etc.
Serves as an FDA submission expert and provides guidance for staff, faculty, and leadership.
Performs other duties as assigned.
Education: Bachelor's degree in scientific field of study related to the research of the clinic.
Experience: Five (5) years clinical research including three (3) years in the relevant research specialization.
Certification/Licensure: SoCRA or ACRP certification strongly preferred.
Other: Master's degree in related field may be substituted for two (2) years of related experience.
Knowledge, Skills, and Abilities
Knowledge of position requirements. Knowledge of all applicable requirements, regulations, and laws. Skill in effective use of applicable technology/systems. Ability to effectively communicate both verbal and written thoughts, ideas, and facts. Ability to work cooperatively with others and independently.
Hiring Range: Commensurate with education and experience.
If accommodations are needed, contact Staffing & Career Services at 410-706-2606, Monday - Friday, 8:30am - 4:30pm EST. Maryland Relay can be accessed by dialing 711 (in-state) or 1-800-735-2258.
UMB is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law or policy.
Job: Reg or CII Exempt Staff - E3324F
Employee ClassEmployee Class : Exempt Contingent IIExempt Regular
Full Time/Part Time: Full-Time
Shift: Day Job
Financial Disclosure: No
Organization: School of Medicine - Marlene and Stewart Greenebaum Comprehensive Cancer Center
Job Posting: May 6, 2020
Unposting Date: Jun 6, 2020, 3:59:00 AM
Internal Number: 150381
About University of Maryland, Baltimore
The University of Maryland, Baltimore (UMB) is the State's public health, law and human services university devoted to excellence in professional and graduate education, research, patient care, and public service. As a diverse community of outstanding faculty, staff and students, and using state-of-the-art technological support, we educate leaders in health care delivery, biomedical science, global health, social work and the law. We emphasize interdisciplinary education and research in an atmosphere that explicitly values civility, diversity, collaboration, teamwork and accountability. By conducting internationally recognized research to cure disease and to improve the health, social functioning and just treatment of the people we serve, we foster economic development in the City, State, and nation. We are committed to ensuring that the knowledge we generate provides maximum benefit to society and directly enhances our various communities.