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Senior Clinical Research Associate

Florida, US

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Senior Clinical Research Associate to join a pharmaceutical company

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counterparts.  

 

Main Job Tasks and Responsibilities:

 

Site management and relationship

  • Serve as the primary sponsor/CRO contact for assigned sites, maintaining regular communication with Principal Investigators, sub-investigators, and study coordinators.
  • Track site performance against follow-up visit schedules, data entry timelines, and query resolution metrics; escalate risks early.
  • Support sites through staff turnover, including retraining of new personnel and updates to the delegation log.
  • Ensure sites maintain adequate resources, equipment calibration (e.g., PSG/HSAT devices, CPAP or study device logs where applicable), and storage of investigational product or devices.

Monitoring and oversight

  • Conduct on-site, remote, and risk-based monitoring visits per the Clinical Monitoring Plan, and complete visit reports and follow-up letters within required timelines.
  • Perform source data verification (SDV) and source data review (SDR) of follow-up visit data, including sleep study results (AHI, ODI, oxygen saturation), questionnaires (e.g., Epworth Sleepiness Scale, FOSQ), and device adherence data.
  • Verify ongoing informed consent compliance, including re-consent following protocol or ICF amendments.
  • Review and confirm accurate reporting of adverse events, serious adverse events, and device deficiencies within regulatory timelines.
  • Identify, document, and follow up on protocol deviations, and ensure corrective and preventive actions (CAPAs) are implemented.
  • Oversee investigational product or device accountability, reconciliation, and return or destruction.

Subject retention and follow-up

  • Work with sites to minimize missed visits and loss to follow-up, reviewing retention strategies and tracking visit windows.
  • Monitor early terminations and withdrawals, ensuring reasons are documented and follow-up data is collected where the protocol allows.
  • Ensure completion of all long-term and end-of-study follow-up assessments.

Data quality and database lock

  • Drive timely resolution of data queries in the EDC system and support data cleaning activities.
  • Collaborate with Data Management on interim and final data reviews, and prepare sites for database lock.

Regulatory and documentation

  • Ensure the Investigator Site File (ISF) is complete and reconciled with the Trial Master File (TMF).
  • Track IRB continuing reviews, amendment approvals, safety report submissions, and other required regulatory documents.
  • Prepare sites for sponsor audits and FDA inspections, and support responses to findings.

Closeout and post-study support

  • Plan and conduct site closeout visits, including final IP/device reconciliation, document archiving instructions, and IRB closure notification.
  • Support post-study activities such as final reconciliation, close-out reports, and responses to post-lock data or regulatory requests.
  • Contribute to lessons learned and process improvements for the study team.

 

 

Education and Experience:

 

Required

  • Bachelor's degree in life sciences, nursing, pharmacy, or a related health field (or equivalent experience).
  • 2+ years of independent on-site monitoring experience as a CRA with a sponsor, CRO, or medical device company.
  • Working knowledge of ICH E6 Good Clinical Practice, FDA regulations (21 CFR Parts 11, 50, 54, 56, 312 and/or 812), and HIPAA.
  • Experience monitoring studies through follow-up, database lock, and site closeout.
  • Hands-on experience with EDC, CTMS, and eTMF systems.
  • Valid driver's license and ability to travel to assigned sites.
  • Authorization to work in the United States.

Preferred

  • Experience in sleep medicine, respiratory, cardiometabolic, or ENT trials, including OSA studies.
  • Familiarity with polysomnography (PSG), home sleep apnea testing (HSAT), and CPAP or implantable/oral device studies.
  • Medical device trial experience (IDE studies, device accountability, device deficiency reporting).
  • Experience supporting FDA inspections or sponsor audits.
  • Clinical research certification (e.g., ACRP-CP, CCRA, or SOCRA CCRP).

 

 

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

 

Who will you be working for?

 

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical devices, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

 

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

 

Key words:, Clinical Research Associate, CRA, Senior CRA, Field CRA, Home-based CRA, Clinical Research, Clinical Trials, Clinical Monitoring, Clinical Operations, Obstructive Sleep Apnea, OSA, Sleep Apnea, Sleep Medicine, Polysomnography, PSG, Home Sleep Apnea Testing, HSAT, CPAP, Respiratory, Medical Devices, Site Management, Site Monitoring, Monitoring Visits, Interim Monitoring Visits, Close-Out Visits, Source Data Verification, SDV, Risk-Based Monitoring, Patient Retention, Query Resolution, Database Lock, Protocol Deviations, Adverse Event Reporting, Device Accountability, Data Quality, Good Clinical Practice, GCP, ICH-GCP, ICH E6, FDA Regulations, 21 CFR Part 812, IDE, IRB, HIPAA, TMF, eTMF, Investigator Site File, Audit Readiness, FDA Inspection, EDC, CTMS, Medidata Rave, Veeva Vault, ACRP-CP, CCRA, SOCRA CCRP, CRO, Biotech, MedTech, Life Sciences, Pharma, Remote, Home-based, Field-based, Travel, United States, English, Clinical Trials, CRO, Clinical Research Organization, Clinical Research, , Outsourcing, Contract, Temporary, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated

 

#LI-RE1 #LI-REMOTE #TEMPORARY #FUL TIME #ClinicalResearchAssociate #CRA #ClinicalResearch #ClinicalTrials #SleepApnea #OSA #SleepMedicine #ClinicalMonitoring #HiringNow #RemoteJobs

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