Clinical Research Associate

Purpose

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.

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

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

Qualifications/Requirements

Bachelor's degree required, preferably in Clinical Research, Life Sciences or a related field

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

3 years of relevant experience in industry or has worked with Sponsor companies as a clinic coordinator required

Prior study supervision experience required

Clearance of favorable background investigation required

Valid Class “C” drivers license

Up to 50% of travel is required for this role