What are the responsibilities and job description for the Clinical Trials Manager position at Laulima Government Solutions?
The Alaka`ina Foundation Family of Companies (FOCs) is looking for a qualified Clinical Trials Manager to support our government client in Silver Spring, Maryland.
*This is not a remote position. The ideal candidate must be within reasonable commuting distance to provide onsite support.*
DESCRIPTION OF RESPONSIBILITIES:
- Reports directly to the Program Manager.
- Manages all aspects of a clinical trial from pre-study to study close-out for entities such as drug companies, private physicians, academic institutions, and government agencies.
- Defines the trial budget and schedule.
- Reviews clinical research protocols for compliance, logistical support, and to ensure adequate staffing is available and scheduled appropriately.
- Oversees the screening and qualification of potential study subjects.
- Collects and reviews clinical data and ensures that all information needed to achieve the trial objective is obtained (i.e. review source documents, ensure data is entered correctly).
- Monitors progress of the trial and reports any issues to the trial director or physician.
- Trains, supervises, and tracks training requirements for trial staff and ensures that procedures are executed correctly.
- Reviews and updates all Standard Operating Procedures (SOPs) as required.
- Provides back-up coverage for any position to include but not limited to CRC, phlebotomist, recruiter, and administrative assistant.
- Provides and/or coordinates all contractually required reports.
- May be required to work evenings, weekends, and/or occasional nights. Typical work schedule is M-F 6:00AM - 2:30PM.
- Other duties as assigned by Supervisor.
REQUIRED DEGREE/EDUCATION/CERTIFICATION:
- Registered Nurse with five (5) years of experience in Clinical Research.
- Maintain Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA).
- Basic Life Support (BLS -CPR/ AED) certification.
REQUIRED SKILLS AND EXPERIENCE:
- Solid regulatory-affairs experience is required, preferably related to vaccine research (i.e - Phase I vaccine prep/mixing).
- Must be able to work independently following a brief period of specific technical training.
- Ability to establish and maintain effective working relationships with coworkers, managers, and customers.
- Knowledge of applicable highly complex scientific procedures and techniques relating to position.
DESIRED SKILLS AND EXPERIENCE:
Advanced Cardiac Life Support (ACLS) certification encouraged.
REQUIRED CITIZENSHIP AND CLEARANCE:
- Must be a U.S. Citizen
- Must be able to pass a background check for a NACI.
The Alaka`ina Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.
We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not discriminate in employment decisions on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees.
The Alaka`ina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms designated as Native Hawaiian Organization (NHO)-owned and 8(a) certified businesses. The Family of Companies (FOCs) includes Ke`aki Technologies, Laulima Government Solutions, Kpono Government Services, and Kapili Services, Po`okela Solutions, Kkaha Solutions, LLC, and Pololei Solutions, LLC. Alaka`ina Foundation activities under the 501(c)3 principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship.
For additional information, please visit www.alakainafoundation.com
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