S & P Associate

Technical Resources International, Inc.; Bethesda (MD); Hybrid; USD 54,000 - 60,000; Full time

Job summary

Technical Resources International, Inc. is seeking a S&P Associate to support drug safety data operations in Bethesda, MD. The role emphasizes data collection, validation of SAE information, and collaboration with safety and medical teams.

The position requires a Bachelor’s degree, strong attention to detail, excellent communication skills, and proficiency in MS Office; hybrid work arrangement with two days in-office and three days remote is provided.

Qualifications

• Must have excellent attention to detail and strong verbal/written communication.
• Superior organizational and customer service abilities required.
• Proficiency in MS Office; SharePoint a plus.
• Knowledge of drug and vaccine development or clinical trials a plus.

Responsibilities

• Collect, organize, and interpret data to support project safety operations.
• Validate SAE entries to ensure data accuracy and resolve discrepancies.
• Collaborate with Safety Specialists, Managers, Physicians and Medical Monitors for reporting.
• Prepare data summaries or supporting materials for meetings and presentations.
• Manage safety-related communications to sites, investigators, and regulatory authorities.
• Serve as liaison for safety communications between study sites and the safety team.
• Maintain and organize safety documentation to meet regulatory requirements.
• Oversee safety box management and ensure materials are archived and accessible.
• Track distribution/receipt of safety documents to ensure timelines and compliance.
• Perform MedDRA coding and process SAEs for safety reports.

Skills

Attention to detail

Verbal communication

Written communication

Organizational skills

Customer service

Education

Bachelor's Degree

Tools

MS Office

SharePoint

Job description

S & P Associate - (SPA001_COMPANY_1)

Location: Bethesda, MD 20817 US (Primary)

Category: Drug Safety

Job Type: Full-Time

Salary Range: 54,000.00-60,000.00/YEAR

Education: Bachelor's Degree

Travel: None

Job Description

The Safety Associate is essential for collecting, organizing, and interpreting data accurately to support project‑specific safety operations. The Safety Associate focuses on managing and analyzing safety‑related data under supervision.

Responsible for ensuring data accuracy and completeness by validating entries and resolving discrepancies during SAE process.

Work closely with Safety Specialists, Managers, Physicians and Medical Monitors, and cross‑functional teams to provide accurate data and reports for analysis.

Assist in meetings and presentations by preparing data summaries or supporting materials.

Responsible for Safety‑Related Distributions: Manage and distribute safety‑related communications, such as safety reports, adverse event notifications, and updates, to relevant stakeholders, including study sites, investigators, and regulatory authorities.

Responsible for Site Communications: Serve as a liaison for safety‑related communications between study sites and the safety team. Ensure timely and accurate communication of safety issues, clarifications, or updates to clinical sites.

Responsible for Document Control: Maintain and organise safety documentation, ensuring that all safety‑related records (e.g., SAE reports, safety letters, regulatory submissions) are stored, tracked, and updated in compliance with project‑specific and regulatory requirements.

Responsible for Safety Box Management: Oversee the maintenance and tracking of safety boxes, ensuring all required documents and safety reports are available, properly archived, and readily accessible.

Tracking Compliance: Monitor the distribution and receipt of safety‑related documents to ensure compliance with project timelines and regulatory guidelines. Track the status of safety reports, document submissions, and follow‑ups.

This role is essential for ensuring that all safety‑related documents and communications are managed systematically, ensuring compliance with regulatory and project‑specific standards.

Experienced Safety Associates are responsible for performing MedDRA coding and processing Serious Adverse Events (SAEs) to contribute to the development of comprehensive safety reports.

Job Requirements

Must have excellent attention to detail, verbal and written communication skills.

Superior organizational skills and customer service abilities are required.

Proficiency in MS Office (Word, Excel, and Outlook); experience with SharePoint is a plus.

General knowledge of the drug and vaccine development process or clinical trials is a plus.

B.A./B.S. Degree

• This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.

We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.