Senior Clinical Research Associate – CRO-Contract

Evolution Research Group

. Independently manage and monitor site activities for assigned clinical studies .

Posted 10/3/2026contractRemote • Maryland • United StatesSenior💰 $0 - $110 per hourWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing clinical study activities, ensuring compliance with ICH-GCP guidelines, FDA regulations, and effective communication with investigational sites. Proficient in site evaluation, training personnel, and maintaining audit-ready documentation.

Highest-signal resume keywords

Clinical Research Associate (CRA) ExperienceExpert Knowledge of ICH GuidelinesProficiency in Electronic CRF PlatformsBachelor's Degree in Life Science/HealthcareAbility to Travel Up to 100%

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site QualificationSite InitiationInterim MonitoringClose-Out VisitsClinical Trial Material AccountabilityInvestigational Product ReconciliationDocument ManagementRegulatory ComplianceStudy File ReconciliationQuery Resolution

Soft Skills

Excellent Interpersonal SkillsOrganizational SkillsMultitasking SkillsAttention to DetailProfessional Judgment

Tools & Technologies

Electronic CRF PlatformsDocument SoftwareSpreadsheet SoftwarePresentation SoftwareEmail

Industry Keywords

Clinical ResearchDrug Development ProcessFDA RegulationsICH-GCP GuidelinesSite Management

About the role

Key responsibilities & impact

Independently manage and monitor site activities for assigned clinical studies
Conduct site qualification, site initiation, interim monitoring, and close-out visits
Ensure compliance with protocols, Lotus or Sponsor SOPs, FDA regulations, and ICH-GCP guidelines
Perform site evaluation visits and assess investigators’ site capabilities
Conduct study initiation activities, review protocols and regulatory issues, and train site personnel
Ensure Investigator Site Files remain audit-ready and documents are uploaded to the Trial Master File
Communicate with investigational sites regarding visit planning, query resolution, action items, and site management
Document clinical trial material accountability, stability, and storage conditions; perform investigational product inventory
Coordinate site correspondence and ensure timely transmission of clinical data
Perform close-out visits, investigational product reconciliation and disposition, study file reconciliation, query resolution through database lock, and outstanding action-item resolution
Complete internal and study-related training within required timelines
Complete pre- and post-visit follow-up, including confirmation letters, follow-up letters, and monitoring visit reports
Collaborate with the CRA Line Manager on mentoring, training, and assessment of CRAs and junior staff as applicable

Requirements

What you’ll need

Bachelor's degree or equivalent experience in life science/healthcare
At least 5 years of field experience working within clinical research as a CRA
Mastery of the CRA II Job Responsibilities
Valid Driver’s License
Legally authorized to work in the US as an independent contractor (LLC or INC.) or through an agency
Ability and willingness to travel up to 100% of the time, both domestically by land and air
Expert knowledge of the drug development process, ICH guidelines, GCP, and the clinical trial process
Proficiency in using electronic CRF platforms and processes
Excellent interpersonal, organizational, and multitasking skills
Exceptional attention to detail and professional judgment
Ability to uphold ICH GCP guidelines and determine appropriate action for complex problems
Ability to manage multiple deadlines and work independently
Proficient computer skills and working knowledge of email, document, spreadsheet, and presentation software
Ability to submit invoices and expense reports timely according to Finance Department requirements
Ability to meet physical demands including occasional lifting/carrying up to 10 pounds
Must follow safety, environmental, infection control, and protective-equipment requirements when traveling or visiting clinical research sites

Benefits

Comp & perks

Contractor is responsible for their own insurance
Home office environment option
Opportunity to support mentoring, training, and assessment of CRAs and junior staff