Clinical Research Associate II – FSP

Precision For Medicine

. Oversee all aspects of study site management to protect patient safety and ensure high-quality data and acceptable Quality Assurance reports .

Posted 10/27/2026full-timeRemote • United StatesJuniorMid-Level💰 $91,500 - $137,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical research site management, ensuring compliance with ICH-GCP and local regulations while maintaining high-quality data integrity and patient safety. Proficient in managing study-specific tools, conducting monitoring visits, and facilitating effective communication with investigators and study staff.

Highest-signal resume keywords

Clinical Research Associate (CRA) ExperienceSite ManagementICH-GCP ComplianceStudy MonitoringRegulatory Document Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Study Site ManagementAudit PreparationInformed Consent VerificationData Discrepancy ResolutionTrial Management ToolsBudget NegotiationRegulatory SubmissionsPatient Recruitment StrategiesElectronic Data Capture (EDC)Serious Adverse Event Identification

Soft Skills

Excellent CommunicationOrganizational SkillsTeam PlayerClient-Focused Approach

Tools & Technologies

Computerized Information SystemsElectronic SpreadsheetsWord Processing SoftwareElectronic Mail

Industry Keywords

Clinical ResearchCROQuality AssuranceInvestigator MeetingsTrial Master FilesPatient SafetyClinical Trial Management

About the role

Key responsibilities & impact

Oversee all aspects of study site management to protect patient safety and ensure high-quality data and acceptable Quality Assurance reports
Provide guidance at site and project level toward audit readiness and support audit preparation and follow-up actions
Update, track and maintain study-specific trial management tools, systems and status reports
Manage site start-up procedures when required, including investigator feasibility and recruitment, EC/IRB submissions, regulatory document collection and review, informed consent adaptation, notifications, translations and meeting organization
Assist with study budget negotiation and investigator contract execution when required
Verify informed consent processes and documentation; assess subject safety and clinical data integrity risks
Independently conduct pre-study/qualification, initiation, routine monitoring and close-out visits in accordance with protocols, local laws, ICH-GCP and Precision SOPs
Prepare timely monitoring reports for on-site and remote visits
Document activities through confirmation letters, follow-up letters, trip reports, communication logs and other required project documents
Support subject/patient recruitment, retention and awareness strategies
Enter observations, status updates and action items into tracking systems and drive them to resolution
Review Investigator Site Files for accuracy, timeliness and completeness and reconcile them with Trial Master Files
Ensure investigator sites understand essential-document archiving requirements
Communicate protocol and study issues with site personnel and Precision Project and Clinical Trial Management
Maintain relationships with investigators and study staff and represent Precision’s quality and professional image
Perform investigational product inventory, reconciliation, storage and security reviews
Verify investigational product dispensing and administration and manage related blinded/randomized information and regulatory procedures
Perform remote EDC CRF and patient-profile data reviews, resolve queries and assist with data discrepancy resolution
Identify and process Serious Adverse Events according to study procedures
Identify site risks, escalate them with proposed contingencies and own timely resolution
Attend Investigator Meetings, sponsor meetings, global monitoring/project meetings and required clinical training
Travel as necessary according to project needs
Perform other duties assigned by management

Requirements

What you’ll need

4-year college degree or equivalent experience in a scientific or healthcare discipline
Two (2) years or more as a CRA in a CRO or equivalent, relevant experience and/or demonstrated competencies
Site management or equivalent experience in clinical research
Excellent communication and organizational skills
Team player
Client-focused approach
Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail
Ability to travel overnight
Up to 60% travel on average, based on regional requirements; international travel as needed
Fluency in English and, for non-English speaking countries, the local language of the country where the position is based
Candidates must be legally authorized to work in the country of employment without employer sponsorship

Benefits

Comp & perks

Discretionary annual bonus
Health insurance
Retirement savings benefits
Life insurance
Disability benefits
Paid parental leave
Paid time off for sick leave and vacation
Volunteer time off
Robust medical offerings
Non-vested 401(k) plus company match
Professional growth support
Reasonable travel and work/life balance