Bachelor's degree in life sciences, nursing, pharmacy, or related field.
2+ years of independent on-site monitoring experience as a CRA.
Knowledge of ICH E6 Good Clinical Practice and FDA regulations.
Experience with EDC, CTMS, and eTMF systems.
Valid driver's license and ability to travel to sites.
Authorization to work in the U.S.
Responsibilities
Serve as the primary contact for assigned sites, ensuring effective communication.
Track site performance and escalate risks early.
Conduct on-site and remote monitoring visits as per the Clinical Monitoring Plan.
Perform source data verification and ensure informed consent compliance.
Identify and document protocol deviations, implementing corrective actions.
Drive timely resolution of data queries and support data cleaning activities.
Plan and conduct site closeout visits, ensuring all documentation is complete.
Benefits
Opportunity to work directly with a single sponsor while benefiting from a global CRO's resources.
Career growth potential within a supportive team environment.
Flexibility of remote work options.
Engagement in diverse clinical trials, particularly in sleep medicine.
Full Job Description
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
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.
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.
