Clinical Research Associate II – FSP

Precision Medicine Group

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

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

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in clinical research site management, ensuring patient safety and data quality while adhering to regulatory guidelines. Proficient in managing study start-up procedures, monitoring activities, and maintaining effective communication with study personnel.

Highest-signal resume keywords

Clinical Research Associate (CRA) ExperienceSite Management ExperienceEDC Trial MonitoringRegulatory Document CollectionFluency in English

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Study Site ManagementProtocol Monitoring GuidelinesInformed Consent ReviewPharmacovigilanceBudget NegotiationData Discrepancy ResolutionSerious Adverse Events IdentificationTrial Master File ReconciliationInvestigator Contract ExecutionSite Start-Up Procedures

Soft Skills

Excellent Communication SkillsOrganizational SkillsClient-Focused Approach

Tools & Technologies

Computerized Information SystemsElectronic SpreadsheetsWord ProcessingElectronic Mail

Industry Keywords

Good Clinical Practice (GCP)International Conference on Harmonisation (ICH)BiopharmaLupus MonitoringRare Therapeutic Areas

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Oversee all aspects of study site management to protect patient safety and ensure high-quality data
Provide guidance on audit readiness and support audit preparation and follow-up actions
Maintain study-specific trial management tools, systems and status reports
Manage site start-up procedures, including investigator feasibility and recruitment, EC/IRB submissions, regulatory document collection, informed consent review, notifications, translations and meetings as required
Assist with study budget negotiations and investigator contract execution
Verify informed consent processes and assess subject safety, protocol deviations and pharmacovigilance issues
Independently conduct pre-study, qualification, initiation, routine monitoring and close-out site visits
Prepare timely monitoring reports and maintain confirmation letters, follow-up letters, trip reports and communication logs
Support subject recruitment, retention and awareness strategies
Review Investigator Site Files and reconcile them with Trial Master Files
Communicate protocol and study issues to site personnel and Precision project and clinical trial management teams
Maintain effective relationships with investigators and study staff
Manage investigational product inventory, reconciliation, storage, security, dispensing and administration verification
Perform remote EDC CRF and patient profile reviews, resolve queries and assist with data discrepancy resolution
Identify and process Serious Adverse Events according to study procedures
Identify site risks, escalate them and own timely resolution with minimal support
Attend investigator, sponsor, global monitoring and clinical training meetings
Travel as required by 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
Client-focused approach
Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail
Ability to travel overnight, up to 60% 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
Graduate or postgraduate degree preferred
Lupus monitoring experience preferred
Experience monitoring in rare and complex therapeutic areas preferred
Experience monitoring EDC trials and EHR records preferred
Experience in biopharma or relevant therapeutic area preferred
Relevant site start-up experience preferred
Ability to monitor study sites according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines preferred
Ability to resolve project-related problems and prioritize workload to meet deadlines with minimal management support preferred
Candidates must be legally authorized to work in the country of employment without employer sponsorship

Benefits

Comp & perks

Paid time off
Volunteer time off
Robust medical offerings
Non-vested 401(k) with company match
Paid parental leave
Discretionary annual bonus
Health insurance
Retirement savings benefits
Life insurance
Disability benefits
Paid time off for sick leave and vacation