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DSMB Admin Coordinator

Employer
Frederick National Laboratory for Cancer Research
Location
United States
Start date
Feb 3, 2025
View more categoriesView less categories
Discipline
Administration, Clinical, Clinical Project Management
Required Education
Bachelors Degree
Position Type
Full time

Job Details

DSMB Admin Coordinator

Job ID: req4237
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: Telework: US
Location: USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

PROGRAM DESCRIPTION
Within Leidos Biomedical Research Inc., operator of the Frederick National Laboratory for Cancer Research, the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to high-profile domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), and several other institutes within NIH.  CMRPD’s ability to provide rapid responses and high-quality solutions, and to recruit and retain experts with a variety of backgrounds, allows the directorate to facilitate strategic support to the growing clinical research portfolios of NCI, NIAID, and other NIH divisions/offices/centers. CMRPD’s support services are aligned with the program’s mission to provide comprehensive clinical trials operations and program/project management services to advance scientific clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD services include clinical trials monitoring, regulatory affairs support, clinical safety oversight, protocol navigation/protocol development, and programmatic and project management support to facilitate the conduct of more than 400 Phase I, II, and III domestic and international trials annually. These trials investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, heart, lung, and blood disorders, parasitic infections, and rare and neglected diseases. CMRPD’s collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CMRPD’s mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Monitoring Research Program Directorate (CMRPD) provides regulatory, clinical trials management, pharmacovigilance, protocol development/navigation, and program management support to the National Institute of Allergy and Infectious Diseases’ (NIAID’S) Intramural Clinical Research Community.

This position is 100% remote.  Candidates must reside in the U.S.

KEY ROLES/RESPONSIBILITIES

  • Serve as the Data and Safety Monitoring Board (DSMB) Administrative Coordinator (AC) and provides expertise in safety for clinical research being conducted by NIAID.
  • Organize teleconferences and two semi-annual, all-day meetings for clinical protocols requiring DSMB oversight, including obtaining and distributing study documents, data for reviews, and drafting the DSMB summary notes.
  • Manage communication between the DSMB Executive Secretary, Principal Investigators, and DSMB members.
  • Obtain and maintain curriculum vitae and Conflict of Interest statements for DSMB members and invite ad hoc DSMB members to review specific protocols.
  • Ensure data to be reviewed is prepared and disseminated to members as required.
  • Maintain DSMB membership roster and a list of ad hoc reviewers and their specialty.
  • Prepare reports for the Chairperson and DSMB members describing recommendations, including additional safety steps.

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

  • Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency.
  • In addition to the education requirement, a minimum of five (5) years of progressively responsible clinical nursing experience or equivalent with prior clinical trials and/or safety reporting experience.
  • Knowledge of clinical trial fieldwork concepts and practices, FDA regulations, 21 CFR, and GCPs.
  • Experience in technical writing with concentration in clinical trial safety terms.
  • Ability to work in clinical research setting, both independently and within a team.
  • Ability to exercise good judgment in planning and accomplishing goals.
  • Knowledge of working databases.
  • Demonstrated ability to prioritize multiple tasks/projects through effective organizational/planning skills.
  • Moderate proficiency in Microsoft software applications required.
  • Must be able to communicate effectively with various levels of scientific and administrative personnel.
  • Ability to obtain and maintain a security clearance.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Familiarity with regulatory requirements and guidelines for clinical research.
  • Allergy and infectious disease experience.


Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

82,300.00 - 141,500.00

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

#readytowork

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions

Pay and Benefits

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here

Company

A rewarding career with global impact

Whether you’re an expert in your field or just starting out, we have a career opportunity for you. We’re always looking for people to join us in fulfilling the mission of the Frederick National Laboratory: discovery, innovation, and success in the biomedical sciences.

Our team of 2,400+ scientists, technicians, administrators, and support staff work at the forefront of basic, translational, and preclinical science, with a focus on cancer, AIDS, and other infectious diseases.

We collaborate with colleagues across the National Cancer Institute, National Institutes of Allergy and Infectious Diseases, and others throughout the National Institutes of Health. We also engage with extramural investigators in academia, government and industry.

Your path to joining our team begins with the desire to work for the only national laboratory dedicated to biomedical research. Our employees share a common desire to help make a difference in cancer research and public health concerns. As you search for a career that fits your education, skills, and abilities, explore the core values that guide us and emphasize work-life balance.

Discover why joining the Frederick National Laboratory team could be the most important career step you take

 

 

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Company info
Website
Phone
301-846-1000
Location
8560 Progress Drive
Frederick
MD
21701
United States

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