Clinical Research Associate

RegenTX, LLC is hiring a Clinical Research Associate to oversee operational aspects of clinical trials at investigational sites. The role monitors site performance, supports regulatory compliance and data integrity, and coordinates study activities across multiple trials.

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

Preferred

preferably in Clinical Research, Life Sciences or a related field

Certified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferred

Clinical Research

Life Sciences

CRA Certification

CCRA

CCRP

Company

Human tissue processing and transplantation for orthopedic and wound care.

San Antonio, TX, US

Founded in 2015

11-50 employees

Qualifications

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

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

Capacity to manage travel and multiple site relationships simultaneously

Preferably in Clinical Research, Life Sciences or a related field

Certified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferred

Required skills

ICH-GCP, FDA Regulations, Clinical Research Methodology, Microsoft Office, CRA Certification (CCRA/CCRP), Clinical Study Supervision, Class C Driver’s License

Preferred skills

San Antonio, TX, US, Company data provided by, AI Tools, Customize Your Resume, Maximize your interview chances, Build Cover Letter, Make your application stand out, Analyze How Well You Fit, Understand your strength & weakness

Experience

3+ years