What are the responsibilities and job description for the Clinical Research Coordinator III position at Laulima Government Solutions?
The Alaka`ina Foundation Family of Companies is looking for a qualified Clinical Research Coordinator III to support our government customer in Silver Spring, Maryland.
DESCRIPTION OF RESPONSIBILITIES :
- Organize and prioritize all activities associated with conducting phase 1, 2, and 3 clinical and operational research studies within a military clinic setting.
- Review and understand research protocols, ensuring applicable regulations, and guidelines are followed.
- Coordinate space and supplies with appropriate personnel.
- Recruit volunteers for the studies, to include determining volunteer population availability, advertising venues, and discussions with potential volunteers via telephone or e-mail.
- Serve as a Volunteer advocate and associated duties.
- Maintain study / test article accountability and administration.
- Gather, prepare, and maintain appropriate information and documentation per applicable FDA regulations and ICH guidelines (e.g., source and case report forms, participant rosters, SOPs, etc.)
- Enter required data on CRFs and audit records for accuracy, resolve discrepancies, and correct as necessary.
- Coordinate with external and internal monitors.
- Assist in training research staff on protocol-related study methods.
- Monitor study data collection procedures to ensure uniformly high levels of compliance with GCP, GLP, FDA and other government- or locally-required guidance.
- Able to design and create forms, reports, etc.
- Maintain a safe workplace, observing appropriate safety and occupational health rules and regulations. Attend safety training relative to the position and report any infractions of safety procedures to the facility Safety Officer.
- Other duties as assigned.
REQUIRED DEGREE / EDUCATION / CERTIFICATION :
REQUIRED SKILLS AND EXPERIENCE :
DESIRED SKILLS AND EXPERIENCE :
REQUIRED CITIZENSHIP AND CLEARANCE :
A Tier I background investigation will be required.
The Alaka`ina Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries. Eligible employees enjoy 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. 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 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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