Senior Clinical Research Associate, Protocol & IRB Expert

Automatic Data Processing, Inc.; Bethesda (MD); On-site; USD 78,000 - 149,000; Full time

Benefits offered by this job

Medical, Dental, & Vision Coverage

Paid Time Off and Holidays

401K/Profit Sharing Plan

Flexible Spending Accounts (Healthcare

Dependent Care)

Pre-tax Parking & Transportation Plan

Short-Term & Long-Term Disability

Life & AD&D Insurance

Professional Development/Education

Employee Referral Bonuses

Employee Discount Program

Merit Bonuses

Employee Assistance Program

Travel Assistance Program

Job summary

Global Solutions Network, Inc. (GSN) in Bethesda, MD, seeks a Senior Research Associate (Clinical) to support NIH research programs. The role involves protocol development, regulatory documentation, data management and coordination with IRB staff to ensure compliant study conduct.

The position offers a competitive salary range and comprehensive benefits as part of a long-term, full-time role with federal agency collaboration.

Qualifications

• CITI certification required or preferred.
• Familiarity with Electronic Data Capture (EDC) systems.
• Experience liaising with regulatory authorities (FDA, NIH) is a plus.

Responsibilities

• Assist researchers develop internal research proposals, abstracts, posters and manuscripts.
• Prepare protocol documentation including schemas, calendars and teaching aids.
• Maintain accurate records of protocols, safety reports and annual reports.
• Coordinate with IRB to collect, review and maintain all IRB records.
• Assist with regulatory submissions, including IND/IDE safety and clinical study reports.
• Track study requests, protocol approvals and regulatory submissions.

Skills

CITI certification

Electronic Data Capture (EDC)

Education

Master's degree in a related field

Job description

Global Solutions Network, Inc. (GSN) in Bethesda, MD, seeks a Senior Research Associate (Clinical) to support NIH research programs. The role involves protocol development, regulatory documentation, data management and coordination with IRB staff to ensure compliant study conduct.

The position offers a competitive salary range and comprehensive benefits as part of a long-term, full-time role with federal agency collaboration.