Job description

Overview

About The Geneva Foundation

The Geneva Foundation is a 501(c)3 nonprofit established in 1993 with the purpose to ensure optimal health for service members and the communities they serve. This purpose is accomplished through our mission to advance military medicine through research, development, and education. Our culture is living our core values that focus on a higher purpose. Geneva serves a diverse population and is committed to making diversity, equity, inclusion and belonging a central focus of the employee experience. As a leader in military medical research, we develop critical lifesaving solutions for the global community – and build rewarding careers for our employees.

About The Position

The Clinical Research Coordinator II oversees and administers research study and associated activities. Assists in project planning, and ensures that pre-established work scope, study protocol and regulatory requirements are followed. May recruit and coordinate research subjects, as appropriate, and serves as principal administration liaison for the project. Oversees and coordinates the provision of administrative and staff services to investigators; develops and maintains record keeping systems and procedures.

Responsibilities

• Participates in the design and monitoring of clinical trials
• Analyzes and evaluates clinical data gathered during research
• Ensures compliance with protocol and overall clinical objectives
• Knowledge of FDA regulatory requirements is required
• Familiar with a variety of the field's concepts, practices, and procedures
• Relies on experience and judgment to plan and accomplish goals
• Performs a variety of complicated tasks
• A wide degree of creativity and latitude is expected
• NOTE: Required to be a Registered Nurse licensed to practice in the state of Maryland and Commission for Case Manager Certification (CCNC) certification, 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
• All qualified personnel shall meet all credentialing requirements in accordance with Clinical Trial Monitoring of FDA Regulated Clinical Trials Policy (Command Policy Memorandum 2011-59), Army Regulation (AR) 40-68, Clinical Quality Management, issued 26 Feb 2004, WRAIR Command Policy Memorandum 2017-45, “Walter Reed Army Institute of Research Quality Policy,” and USAMRMC Command Policy 2010-07, “Licensure, Credentialing and Privileging (LCP)” issued 10 Mar 2015, or revisions thereof.
• Promote safety and confidentiality of research participants at all times
• Adhere to Occupational Safety and Health Administration (OSHA), International Air Transportation Association (IATA) Good Laboratory Practices (GLP), and infection control procedures
• Plan, implement and maintain data collection and analysis systems in support of research protocol; may coordinate the collection and analysis of research data
• Recruit, instruct and coordinate research subjects and/or volunteers, as appropriate to specific study objectives and work scope
• Coordinate the day-to-day activities of technical support staff specifically engaged in the carrying out of research/clinical protocol, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectives
• Organize and facilitate meetings, conferences, and other events associated with research activities; may perform and/or coordinate outreach activities, as appropriate to research objectives
• Document all correspondence and communication pertinent to the research
• Interact and communicate effectively with Principal Investigator, other site personnel, research participants, The Geneva Foundation, and the prime partner organization
• Comply with all the rules and regulations as applicable to assigned duty station
• Create and adhere to a data quality and quality assurance plan
• Assist with interim and annual reports. S/he will be the primary liaison at the data collection site and will be responsible for explaining the project to military personnel associated with the study
• Demonstrate proficiency in performing basic study related procedures
• Complete required and applicable research training needed to complete research
• Maintain and update files of all applicable regulatory documentation for IACUC or IRB (including protocols, approvals, amendments, modifications, etc.) as well as any communications with the sponsor or any other Federal or regulatory office (including prior approvals, change in scope, etc.)

Qualifications

• Bachelor’s degree in Nursing, RN, or equivalent required
• 5+ years’ experience in clinical research
• 5 years non-profit, research, or healthcare experience desired
• Certification as a Coordinator required
• Demonstrate competence in oral and written communication
• Must be organized, attentive to detail, and possess a positive, friendly, and professional demeanor
• Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner
• Computer skills including at least intermediate level experience with Excel and other Microsoft Office Software
• Knowledge of CFR, GCP and ICH guidelines

Job Type: Full-time

Pay: From $50,000.00 per year

Benefits:

• Dental insurance
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Weekend availability

Ability to commute/relocate:

• Silver Spring, MD 20910: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• nursing: 5 years (Required)

Work Location: In person

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