Job Details
Overview:
Must be a US Citizen or Green Card Holder
W2 with full benefit
Some travel may be required
Offer contingent on ability to successfully pass a background check and drug screen
Columbus Technologies and Services Inc. is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Columbus offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a Clinical Advisor to work onsite with the National Institutes of Health in Rockville, MD.
This is a long-term position which offers:
- Competitive salary
- Tremendous growth opportunity
- Opportunity to work at NIH, the world's foremost medical research center
- Learn more about what Columbus can do for you at www.columbususa.com
The US base salary range for this full-time position is $45-$65/hr + benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.
Responsibilities:
Implement and coordinate a range of individual clinical site-management activities.
Advise PIs on clinical site start-up and relevant operational and regulatory issues including resource allocation, and administrative issues.
Provide leadership for planning, organizing, and conducting site visits or reverse site visits as appropriate to clinical trials units/clinical research sites to effectively fulfill site management responsibilities.
Assess the level of clinical trials research competency of clinical research sites and the extent of research knowledge and technology available to achieve the desired quantity and quality results for the clinical research trials being conducted.
Evaluate clinical trials units/clinical research sites organizational structures and modes of operations in relationship to the achievement of the Divisions goals and objectives in the areas of administration, clinical site management, and recruitment of patients.
Provide oversight and technical direction for evaluation of site performance.
Identify problems or issues that transcend individual units or trends that indicate the need for procedural clarification or policy development and recommends follow-up actions or policy directives to OCSO Director or Branch Chief.
Conduct trainings at sites and Network meetings on relevant policies/regulations.
Attend Network meetings, conference calls, ad hoc meetings and working groups.
Support federal Program Officers by: 1) tracking and summarizing grantee compliance with training requirements, grantee progress in meeting the grant aims by reviewing progress reports, and adherence to applicable regulations; and 2) reviewing and providing input on training materials, policies and procedures.
Participate in the creation and review of site development and site closure-related documents and checklists.
Interface with networks, investigators, Operations Centers, to share information and collaborate on research and site-related issues.
Prepare oral and written presentations for internal and external programmatic and scientific meetings.
Qualifications:
Travel and Training Requirements:
Travel may be required, at the discretion of the Task Leader.
All Travel must be approved in writing by the Contracting Officer
All travel and training, if approved by the COR and the Contracting Officer, will be funded through a subsequent modification. Please do not include these costs in your task order proposal.
Other Requirements:
This requirement is for a Full Time Equivalent employee, consisting of 1920 hours (excluding Federal Holidays)
Work will be performed up to 40 hours per week during normal business hours, Monday- Friday, excluding Federal holidays.
However, work can run past business hours and flexibility will be needed, and the contractor will be responsible for scheduling.
Telework may be authorized if approved by the Task Leader, COR, and the Contracting Officer.
Specific Qualifications:
Minimum of a BS degree in a science or health related discipline.
Progressive experience in managing clinical trials/clinical research sites and/or monitoring clinical trials, with a minimum of 3 years experience in clinical research
Equal Opportunity/Affirmative Action:
We are committed to hiring and retaining a diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity or expression, marital status, age, national origin, veteran status, disability status, or any other protected class. EEO/AA/MFDV
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