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allied executive solutions
allied executive solutions
1 – 10 Employees
ConsultingNon-profitSocial Impact
Allied Executive Solutions is a consulting firm serving non-profit and social-impact organizations. Its work combines research and development, grant management, and executive support to help mission-driven teams strengthen their operations, pursue sustainable growth, and create lasting benefits for the communities they serve. The company focuses on tailored support designed around each organization’s goals and needs.
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Clinical Research Associate – Hybrid, United States

Monitor clinical trial sites for Allied Research Institute, supporting GCP compliance, reliable data, participant safety, and regulatory readiness.

USUnited StatesNJNew JerseyHybridContractJuniorMiddleEnglish RequiredClinical Research
Google Cloud Platform

Description

  • Lead site selection, initiation, routine monitoring, and close-out visits in line with approved monitoring plans
  • Verify informed consent processes and safeguard participant rights and safety
  • Complete source data verification (SDV) and source data review (SDR)
  • Compare and reconcile clinical trial data with source documentation
  • Raise and resolve data queries with investigative site personnel
  • Oversee investigational product accountability, storage, and dispensing
  • Evaluate site adherence to protocols, ICH-GCP, and applicable regulations
  • Identify, document, and escalate protocol deviations, adverse events, and serious adverse events
  • Maintain and review the Trial Master File (TMF) and site regulatory documentation
  • Develop effective working relationships with investigators, coordinators, and study teams
  • Monitor site performance indicators, including enrollment, query resolution, and data-entry timelines
  • Write monitoring visit reports and follow-up correspondence
  • Train site personnel on protocols, study procedures, and data-entry platforms
  • Support audit and regulatory inspection preparation and subsequent follow-up
  • Serve as the primary liaison between the sponsor or CRO and investigative sites
  • Protect data quality and participant safety throughout the clinical trial lifecycle
  • Promote the organization’s mission, values, and commitment to ethical research
  • Engage in training, team meetings, quality initiatives, accountability, collaboration, and ongoing learning

Requirements

  • Bachelor’s degree in life sciences, nursing, pharmacy, or a related discipline
  • At least 1–3 years of experience as a CRA, clinical trial monitor, or clinical research professional
  • Entry-level applicants with strong clinical or research experience may be considered for Associate CRA roles
  • Practical knowledge of ICH-GCP and applicable regulatory requirements, including FDA and EMA standards
  • Familiarity with trial monitoring activities such as SDV, SDR, and query management
  • Experience using Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS)
  • Strong attention to detail and analytical capability
  • Excellent written and verbal communication skills
  • Willingness and ability to travel to investigative sites when required
  • CCRA, SoCRA, or ACRP certification is preferred
  • Previous experience monitoring multi-site or global clinical trials is preferred
  • Experience in therapeutic areas such as oncology, cardiology, or CNS is preferred
  • Familiarity with risk-based monitoring (RBM) methods is preferred
  • Ability to work in clinical, office, hybrid, or community-based environments as needed
  • Local travel, evening work, or flexible hours may be necessary based on study requirements
  • Commitment to organizational policies, research protocols, regulatory obligations, and compliance standards
  • Ability to maintain precise records and communicate promptly
  • Commitment to protecting research participant rights, safety, dignity, and confidentiality

Benefits

  • Equal opportunity employment with a commitment to non-discrimination
  • Access to training, team meetings, quality improvement initiatives, and performance review processes
  • Flexible scheduling may be available based on study requirements

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