This is a long-term contract position which offers:
- Competitive compensation and comprehensive benefit package
- Optional health, vision, and dental plans
-Vacation leave as well as 10 paid federal holidays and 401K plan.
- Access to NIH’s unparalleled resources and niche scientific initiatives
TASKS/SERVICES. The contractor shall:
- Provide overall support for the administration, oversight and monitoring of clinical studies and clinical trials to Senior Leadership within DEM with the goal of ensuring compliance, safety and improving standardization of these tasks within the division.
- Participate in meetings and provide minutes for the Clinical Science Working Group within the DDEMD.
- Track medium- and high-risk investigator-initiated clinical trials by developing and maintaining files for bi-annual and annual risk assessments and flagging those which require increased oversight, including interim progress reports; produce and submit annual report for studies at high risk to Senior Leadership.
- Establish procedures for tracking of recruitment and retention for clinical studies and clinical trials within the Division.
- Establish and maintain computerized folders of clinical trials according to the format recommended by the Office of Clinical Research Support (OCRS).
- Develop and maintain spreadsheets to track and analyze clinical study oversight processes.
- Use Query/View/Reporting System (QVR), Research Portfolio Online Reporting Tools (RePORT), and other databases to compile reports and presentations to scientific and lay audiences.
- Review protocols and adverse events for clinical studies and clinical trials.
- Oversee activities related to the operation of Data and Safety Monitoring Board (DSMB), Observational Study Monitoring Board- (OSMB) and External Expert Panel (EEP) activities, including identifying and inviting potential members, identifying conflicts of interest and compiling the associated documentation, logistical support for the scheduling of meetings and calls, attending conference calls, taking minutes of calls and meetings, preparing the correspondence from program officials to the investigators and reviewing the investigators’ subsequent response prior to forwarding it to the DSMB/OSMB.
- Act as a resource for Senior Leadership by developing expertise in Standard Operating Procedures (SOPs) for the oversight and monitoring of clinical trials and studies within DDEMD and provide expertise in approaches to improve recruitment and retention of study participants.
- Act as a liaison between DDEMD program staff and the Data Coordinating Centers (DCCs) of clinical trials and studies supported by DDEMD to ensure timely response to action items identified after calls and meetings.
- Act as a liaison between the DCC and the NIDDK repository ensuring timely deposition of samples and data according to current policies.
- Participate in the development of budgets for new clinical trials and studies and track budgets through the course of the clinical trial.
REQUIREMENTS. The contractor must have:
- Master’s degree in Public Health or Nursing or a Bachelor’s degree in Nursing with three (3) years of specialized experience equivalent to a Master’s degree. Specialized experience could include clinical program management or health related program management.
- Minimum of two (2) years of practical experience in clinical trial or clinical study coordination, safety monitoring and oversight within the context of an academic or medical center.
- Strong knowledge of good clinical practices, clinical site monitoring, compliance with regulatory requirements, reporting of adverse events, recruitment and retention of clinical populations.
- Experience with writing of consent forms for Institutional Review Boards.
- Experience in clinical and scientific terminology.
- Excellent organizational, project management, analytical, and computer skills.
- Minimum of intermediate level proficiency in use of MS Office Suite.
- Minimum of intermediate level proficiency in the use of spreadsheets, databases and websites.
- Knowledge of and experience using Pubmed.
- Experience with NIH practices is considered a plus.
PLEASE APPLY ONLINE
When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position; a full job description can be made available at that time.
Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you aren’t contacted for this position, you are still part of our talent network. All Kelly recruiters have access to your profile, which expands your opportunities even further.
As a specialty talent company, Kelly is committed to doing the right thing for our talent and clients. We stand up for equity, inclusion, fair treatment, and opportunity for all as these build the foundation of our Talent Promise. With a focus on safety, value, well-being, investment, and opportunity, Kelly’s Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover what’s next.
It is obvious things are different than they were just a few months ago. Kelly is at the forefront of ensuring the safety of our employees in this new working environment. Be well and stay strong.
Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly® Government offers a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technical, professional, and administrative support roles. Our experts will find you the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. It’s just another way we make the job search work for you.
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity Equal Employment Opportunity is The Law.]]
Why Kelly - Since 2011 we have placed over 16,000 Veterans
Kelly applies targeted recruiting initiatives to the Veterans population (in all stages of transition) by aligning customer defined requirements with military skills and experience. The transition from military to civilian life can be stressful and complex for veterans, and our staff is trained to assist in this transition. Unlike our competition, Kelly places these resources without geographic or industry constraints, offering our customers and our employees greater flexibility. Kelly has a wide variety of local opportunities, for Veterans and their spouses, within our workforce solutions as well as national recruiting programs on behalf of our customers. Kelly’s leading placement opportunities for Veterans are within Information Technology, Engineering, Science, Light Industrial and Call Center.
Our specially trained Veteran recruiters are armed with a number of tools to help Veterans obtain roles that match their potential including skill translation tools, leading Veteran- centric job boards and Veteran/spouse social media networks, among others.
Through Kelly’s vast branch network, we are closely located to the majority of major military installations across the United States. Kelly recruiters participate in onsite and virtual military career fairs as well as advertise through local and national Veteran job boards. In recent years, over 150 Kelly branches have worked directly with their local military installations to recruit spouses and transitioning personnel. These teams not only engages with transitioning talent from local bases, but also have a strong focus on Veterans in areas where the military has identified high Veteran unemployment. This approach ensures that military talent is engaged and shared across the centralized military recruiting team and documented in a centralized database, so that other Kelly locations can benefit from hiring or relocating this valuable pool of talent.
Our focus on military recruiting is a win on multiple levels. Kelly gains top talent with the skills needed to excel; our clients receive the benefit of that talent to help them compete in an ever challenging business landscape; and Veterans receive gainful employment in line with their skills and abilities to ease the transition to the next phase of their lives.
A People Company, Staffing the World
Kelly founded the temporary staffing industry in 1946, and has maintained a leadership position through the years based on a valuable premise: we invest in people. Today that focus benefits our customers wherever they operate around the globe - in a growing number of specialized fields. And we’ll continue to meet the evolving challenges of workforce flexibility with staffing solutions tailored to your precise business needs, both locally and worldwide.
Kelly | ,
Kelly | Emeryville, California
Boston Children's Hospital | Brookline, Massachusetts
Kelly | Rockville, Maryland
Kelly | Elk Grove Village, Illinois
Kelly | Winston Salem, North Carolina
Kelly | Raleigh, North Carolina