Job Description

Clinical Research Associate (CRA) Multiple Openings

Position: Clinical Research Associate (CRA)

Number of Openings: Multiple

Employment Type: Contract

Location: Regional / Field-Based

Travel: Required for clinical site monitoring

Target Locations

We are seeking CRAs based in or within reasonable travel distance of the following markets:

• Boston, MA

• Atlanta, GA / Charlotte, NC

• Tampa, FL / Orlando, FL

• Philadelphia, PA / Washington, DC

• Phoenix, AZ

• Los Angeles, CA

• Chicago, IL

Position Overview

K3-Innovations is seeking experienced Clinical Research Associates (CRAs) to support clinical trial monitoring activities across multiple U.S. regions.

The CRA will be responsible for monitoring assigned investigative sites and ensuring clinical studies are conducted in accordance with the study protocol, applicable Standard Operating Procedures (SOPs), ICH-GCP requirements, and applicable regulatory requirements.

We are specifically seeking candidates with strong, hands-on independent site monitoring experience who are comfortable managing multiple investigative sites and traveling within their assigned region.

The ideal candidate will have demonstrated experience conducting site monitoring visits, identifying and resolving site-level issues, reviewing source documentation and clinical data, maintaining inspection-ready documentation, and developing effective working relationships with investigators and site personnel.

Key Responsibilities

• Independently manage assigned investigative sites throughout the clinical study lifecycle.

• Conduct Site Qualification/Pre-Study Visits, Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs) as required.

• Perform remote and onsite monitoring activities in accordance with the study monitoring plan.

• Verify that clinical trials are conducted in compliance with the approved protocol, ICH-GCP, applicable regulations, SOPs, and study-specific requirements.

• Perform source data review and source data verification, as applicable to the study and monitoring strategy.

• Review informed consent documentation and confirm appropriate informed consent processes are being followed.

• Review subject eligibility and protocol compliance.

• Monitor investigational product accountability, storage, handling, dispensing, reconciliation, and associated documentation, as applicable.

• Review site regulatory documents and support maintenance of complete and inspection-ready Investigator Site Files.

• Review clinical data and work with investigative sites to resolve data discrepancies and outstanding queries.

• Identify protocol deviations, compliance concerns, enrollment challenges, data-quality issues, and other site-level risks.

• Document monitoring findings clearly and prepare accurate, timely monitoring visit reports and follow-up communications.

• Track monitoring findings, action items, and site issues through resolution.

• Escalate significant quality, compliance, patient safety, or study execution concerns appropriately.

• Support sites with recruitment, enrollment, retention, data entry, query resolution, and study-specific operational challenges.

• Maintain regular communication with Principal Investigators, Study Coordinators, and other site personnel.

• Collaborate closely with Clinical Trial Managers, Project Managers, Data Management, Medical Monitoring, Safety, Regulatory, and other study team members.

• Participate in study team meetings, investigator meetings, CRA meetings, and study-specific training.

• Maintain required study documentation and ensure assigned sites remain inspection ready.

• Manage monitoring schedules and travel efficiently across the assigned geographic territory.

• Ensure monitoring activities, reports, follow-up letters, expense reports, and other required documentation are completed within established timelines.

Required Qualifications

• Bachelor's degree in life sciences, nursing, healthcare, or a related discipline preferred; equivalent relevant clinical research experience may be considered.

• Minimum 2+ years of independent clinical site monitoring experience as a CRA.

• Demonstrated experience independently conducting SIVs, IMVs and COVs .

• Strong understanding of ICH-GCP and applicable FDA clinical research regulations .

• Experience managing multiple investigative sites concurrently.

• Demonstrated ability to identify site-level risks and drive issues through resolution.

• Experience reviewing source documentation, informed consent, protocol compliance, regulatory documentation, and investigational product accountability.

• Strong monitoring report writing and documentation skills.

• Excellent organizational and time-management skills.

• Strong verbal and written communication skills.

• Ability to develop productive relationships with investigators, study coordinators, and cross-functional study teams.

• Ability to work independently in a field-based environment while collaborating effectively with a broader clinical study team.

• Ability and willingness to travel regularly to investigative sites within the assigned territory.

Preferred Qualifications

• 3 5+ years of CRA monitoring experience within pharmaceutical, biotechnology, or CRO environments.

• Experience across Phase I IV clinical trials.

• Experience working on complex or multi-site clinical studies.

• Experience with risk-based monitoring approaches and centralized monitoring outputs.

• Experience with major clinical trial systems, including EDC, CTMS, eTMF, and electronic site documentation platforms.

• Previous experience working with sponsors and/or CROs in a dedicated or FSP monitoring model.

• Experience supporting site activation, enrollment, study maintenance, database lock, and study closeout activities.

• Experience participating in inspection-readiness activities.

Key Skills

Successful candidates should demonstrate:

• Strong independent clinical site monitoring capabilities

• Excellent site management and relationship-building skills

• Strong knowledge of ICH-GCP and clinical trial regulations

• High attention to detail and documentation quality

• Effective risk identification and issue resolution

• Strong organization and prioritization

• Ability to manage multiple sites and competing deadlines

• Clear and professional written and verbal communication

• Ability to work independently and take ownership of assigned sites

• Flexibility and willingness to travel

Geographic Requirements

Candidates should be located within practical travel distance of one of the following regional hubs:

Northeast: Boston, MA; Philadelphia, PA; Washington, DC

Southeast: Atlanta, GA; Charlotte, NC; Tampa, FL; Orlando, FL

Midwest: Chicago, IL

Southwest: Phoenix, AZ

West Coast: Los Angeles, CA

Candidates must be comfortable with regional travel to investigative sites based on study requirements.

Job Tags

Contract work, Interim role, Remote work

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