Senior Clinical Research Associate

System One, Inc.; Bethlehem (Northampton County); Remote; USD 74,000 - 105,000; Part time

Benefits offered by this job

Health benefits

401(k) plan

Job summary

System One, Inc. is seeking a Senior Clinical Research Associate (Sr. CRA) to support multiple clinical studies remotely from the US. You will monitor sites, coordinate trials, ensure ICH-GCP compliance, and collaborate with cross-functional teams.

Responsibilities include site qualification, initiation, interim monitoring, close-out visits, TMF/eTMF review, data review, and regulatory submissions while managing vendors and study timelines.

Qualifications

• 4+ years CRA experience with strong preference for Sr. CRA
• Hands-on site monitoring experience and ability to conduct visits
• Experience reviewing monitoring plans and ensuring protocol/SOP compliance
• Familiarity with ICH-GCP, FDA regulations, and trial documentation
• Experience with TMF/eTMF and electronic data capture (EDC)
• Excellent verbal and written communication; vendor/CRO oversight
• Experience with medical device/IVD studies is a plus

Responsibilities

• Conduct and oversee clinical site monitoring activities.
• Perform site qualification, initiation, interim monitoring, and close-out visits.
• Review and develop monitoring plans.
• Ensure study compliance with protocols, SOPs, ICH-GCP, FDA requirements, and applicable regulations.
• Prepare monitoring visit reports and follow-up documentation.
• Identify qualified investigators and support site selection.
• Provide investigator and site coordinator training.
• Support multiple clinical studies simultaneously.
• Manage site start-up activities, regulatory documentation, enrollment, and study close-out.
• Coordinate clinical study deliverables and timelines.
• Support site budgets and vendor coordination.
• Communicate progress and issues to management.
• Develop and review study protocols, informed consent forms, monitoring plans, and data collection forms.
• Work with EDC systems and TMF/eTMF.
• Assist with regulatory submission documentation.

Skills

CRA experience

Site monitoring

Cross-functional collaboration

EDC experience

TMF/eTMF experience

Regulatory compliance

Education

Bachelor's degree in Science or Nursing

Tools

EDC systems

TMF/eTMF systems

Job description

Job Title: Senior CRA

Location: Bethlehem, Pennsylvania

Type: Contract

Compensation: $65/hr

Work Model: Remote - US

Hours: Monday–Friday, 8:00 AM–5:00 PM, 1-hour lunch

Overview

The Senior Clinical Research Associate (Sr. CRA) is responsible for assisting with the execution of clinical studies by COMPANY. Responsibilities include coordinating, monitoring, and oversight of the clinical studies to ensure compliance with the protocol and SOPs, ICH GCP, and all applicable regulatory standards. The Sr. CRA will also participate as a member of cross-functional core teams, manage vendors, and supervise CRAs

Responsibilities

• Conduct and oversee clinical site monitoring activities.
• Perform site qualification, initiation, interim monitoring, and close-out visits.
• Review and develop clinical monitoring plans.
• Ensure study compliance with protocols, SOPs, ICH-GCP, FDA requirements, and applicable regulations.
• Prepare monitoring visit reports and follow-up documentation.
• Identify qualified investigators and support site selection.
• Provide investigator and site coordinator training.
• Support multiple clinical studies simultaneously.
• Manage site start-up activities, regulatory documentation, enrollment, and study close-out.
• Coordinate clinical study deliverables and timelines.
• Support site budgets and vendor coordination.
• Communicate study progress, challenges, and updates to management.
• Develop and review study protocols, informed consent forms, monitoring plans, clinical study reports, and data collection forms.
• Work with Electronic Data Capture (EDC) systems.
• Establish, maintain, and review Trial Master Files (TMF/eTMF).
• Review monitoring reports and clinical data for accuracy and completeness.
• Support database activities and clinical data review.
• Assist with regulatory submission documentation.
• Oversee CROs, clinical vendors, and laboratory vendors.
• Track study deliverables, budgets, and timelines.
• Coordinate with R&D, marketing, labeling, and other internal departments.
• Support regulatory inspections and audit readiness.

Requirements

• 4+ years CRA experience (5+ years preferred).
• Previous Sr. CRA experience (strong preference).
• Hands‑on site monitoring (must have personally conducted monitoring visits).
• Monitoring plans (ability to review and execute monitoring plans).
• Multiple study management (strong multitasking and prioritization).
• EDC experience (clinical data systems).
• TMF/eTMF experience (documentation management and review).
• GCP / FDA regulations (clinical trial compliance).
• Bachelor's degree required (Science or nursing preferred; other fields considered with relevant experience).
• Strong verbal and written communication skills.
• AI tools / automation experience (must explain practical experience and use cases).
• Medical device / IVD studies experience (preferred).
• Usability experience (preferred).
• Vendor / CRO oversight experience (preferred).

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

#LI-

Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.