Clinical Research Coordinator III

Clinical Research Coordinator

The Alaka`ina Foundation Family of Companies is looking for a Clinical Research Coordinator 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 guidances.
• 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 to be a Registered Nurse licensed to practice in the state of Maryland, who are skilled and qualified in nursing procedures to include, but not limited to phlebotomy and the administration of experimental vaccines and other parenteral therapeutics as per specific protocol guidance in accordance with the 21 Code of Federal Regulation (CFR) 11, 50, 54, 56, 312, and 314.
• Basic Life Support (BLS CPR/AED) certification.
• Maintain Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA)

Required Skills and Experience:

• Four (4) years clinical trials experience.
• Five (5) years of experience in clinical research coordination, with expertise in FDA-regulated trials.
• Experience facilitating clinical monitoring visits and resolving inquires.
• Experience utilizing clinical trial management systems and databases (e.g., REDcap and Inform).
• Must be able to work both independently and in a team setting.
• Must have excellent communication, organization, and prioritization skills.
• Intermittent physical activity including bending, reaching, and prolonged periods of sitting and or standing.
• May be required to work at any facility and be responsible for own transportation.
• Will be scheduled based on operational and business needs.
• Required Knowledge, Skills and Abilities; knowledge of applicable highly complex scientific procedures and techniques relating to position.
• Physical Capabilities: work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material.
• Work Environment: Clinic/laboratory environment; may require working evenings and weekends.
• Must be able to work independently and mentor other Clinic staff.
• 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.

Desired Skills and Experience:

• Advanced Cardiac Life Support (ACLS) certification encouraged.
• Certification in clinical research (e.g., CCRP or CCRA) is preferred.
• Commission for Case Manager Certification (CCMC) certification preferred.

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 of individuals with disabilities and veterans. We are proud to state that we do not illegally discriminate in employment decisions on the basis of any protected categories. 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.

EOE, including Disability/Vets

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, K?pono Government Services, and Kapili Services, Po`okela Solutions, K?kaha 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.

Alakaina Family of Companies