Clinical Research Specialist
The University of Maryland, Baltimore (UMB) Marlene & Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is recruiting for a full time, contractual with benefits Clinical Research Specialist. This position is responsible for implementing clinical research protocols on behalf of the faculty/principal investigator. This position is the primary interface, along with the faculty member for cancer patients enrolled in clinical trials. This position is responsible for screening, enrolling and consenting the patients and subsequently guiding the patient through the research protocol, their courses of care/medication, research visits, data collection, standard of care issues and direct research support. This position works directly with the medical care team, ancillary hospital staff, the Sponsor, and data managers in the Cancer Center.
UMB offers a comprehensive and competitive benefits package to eligible employees. This is a contractual position that offers a generous leave package of 10 vacation days, 3 personal days, 8 holidays, and 5 sick days; comprehensive health insurance and supplemental retirement options; professional learning and development opportunities; and limited tuition remission for employees enrolled at UMB.
Essential Functions
- Assists with the development of project timelines, work plan, recruitment strategy, and progress through the duration of the research study or clinical trial. Collaborates with Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials.
- Oversees day to day clinical research operations and leads study initiation, execution, and completion. Oversees interaction with subject participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented, counseling, and obtaining patient medical history.
- Performs day-to-day operational duties such as: ensuring quality control and safety compliance; serving as liaison with IRB; submitting invoicing; developing procedures; ordering supplies.
- Performs other related duties as assigned.
Qualifications
Education: Bachelor's degree in epidemiology, sociology, psychology, nursing or field of study related to the research of the clinic.
Experience: Three (3) years of experience in a clinical research setting, with two (2) years in a relevant specialization.
License/Certification: SOCRA certification desirable but not required.
Other: May consider a combination of directly related experience and education.
Knowledge, Skills, and Abilities
- Ability to understand and utilize scientific/medical terminology and research theory in both oral and written communications.
- Ability to perform independent projects.
- Ability to network with and provide information to key groups and individuals, and work as part of a team.
- Knowledge of human subjects research, the regulations and policies surrounding it.
- Prior experience with patients and patient interaction.
- Ability to represent the Cancer Center and its faculty in a professional manner.
- Ability to keep patient information confidential, knowledge of HIPPA regulations.
Equal Opportunity/Affirmative Action Employer. Minorities, women, protected veterans and individuals with disabilities are encouraged to apply.