Clinical Research Associate

Extremity Care•San Diego, CA

1d•Onsite

About The Position

The Clinical Research Associate (CRA) is responsible for overseeing the operational aspects of clinical trial conduct at investigational sites to ensure data integrity, regulatory compliance, and adherence to Good Clinical Practice (GCP) guidelines. This role supports multiple clinical trials across various therapeutic indications and is instrumental in monitoring site performance, resolving issues, and facilitating communication between sponsor and site personnel.

Requirements

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
Bachelor's degree required, preferably in Clinical Research, Life Sciences, or a related field
Equivalent clinical experience may be considered in lieu of a degree, including experience as a Physician Assistant (PA), Registered Nurse (RN), Emergency Medical Technician (EMT), or other relevant healthcare professional
3 years of relevant experience, preferred with at least two years of experience in industry or has worked with Sponsor companies as a clinic coordinator
Prior study supervision experience required
Valid class C drivers license required
Clearance of favorable background investigation required

Nice To Haves

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

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 close-out 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