Note: The job is a remote job and is open to candidates in USA. RegenTX, LLC is seeking a Clinical Research Associate to oversee the operational conduct of clinical trials at investigational sites. The role is responsible for site monitoring, regulatory compliance, data integrity, trial documentation, enrollment support, and coordination with sponsors, investigators, and internal teams across multiple studies.
Responsibilities
- Evaluate clinical trial resourcing requirements for qualification (SQVs), training (SIVs), monitoring (IMVs) and support of sites during the conduct of the trials
- Work with multiple trial sites and multiple studies of varying indications simultaneously
- Develop and maintain a monitoring plan for assigned clinical trial(s)
- Liaise with external clinic and/or hospital investigators and associated staff conducting the trial as required to ensure the study and monitoring activities are meeting expectations from start of study to end
- Oversee the setup of the trial sites; ensuring each site has the appropriate trial materials to conduct the study
- Oversee site activation process for each study
- Develop and monitor metrics to evaluate the monitor and site performance. In the event of performance concerns, evaluate cause and mitigate risk to study
- Periodically review data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring
- Track patient enrollment and recommend solutions to trial site staff to increase appropriate enrollment of qualified subjects
- Provide support for the processing of data queries, deviations, adverse events, etc
- Write monitoring visit reports
- Develop and execute a plan to close trial sites on completion of the trial and perform associated closeout activities
- Ensure adherence to ICH-GCP, Standard Operating Procedures (SOPs), IRB regulation, and study protocols
- Ensure adherence for regulatory compliance of investigational sites with SOPs, FDA regulations, and ICH guidelines
- Coordinate with team data management activities
- Generate protocol and Informed Consent drafts for management review
- Create Literature Reviews for new study indications
- Assist with CRF development
- Assist with investigator meetings
- Create study status data tables and slide decks for upper management review
- Create and maintain study site investigator binders from study start to end
- Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures
- Start job responsibilities punctually and ensure consistent presence throughout the entire shift to complete responsibilities properly and attend all scheduled meetings and appointments
- Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary
- Perform other duties as assigned
Skills
- Bachelor's degree required
- 3 years of relevant experience in industry or has worked with Sponsor companies as a clinic coordinator required
- Prior study supervision experience required
- Valid Class “C” drivers license
- Preferably in Clinical Research, Life Sciences or a related field
- Certified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferred
- In-depth understanding of ICH-GCP, FDA regulations, and clinical research methodology
- Strong organizational and problem-solving abilities with an eye for detail
- Proficiency with Microsoft Office (Word, Excel, PowerPoint)
- Effective verbal and written communication skills
- Ability to work both independently and collaboratively in a fast-paced environment
Benefits
- Remote work arrangement
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