Senior Clinical Research Associate

About the role

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.