Clinical Operations Associate

United Consulting Hub; New Jersey; On-site; USD 34,000 - 55,000; Part time

Job summary

United Consulting Hub, Inc. is seeking a motivated Clinical Operations Associate to support trial planning, coordination, and documentation in pharma, biotech, and medical device organizations. This contract role involves handling study records, tracking progress, and coordinating with cross-functional teams.

You will assist with site activation, TMF maintenance, and regulatory compliance under ICH-GCP guidelines. Ideal for candidates with 0-2 years' experience and strong organizational skills.

Qualifications

• Basic understanding of clinical research and trial operations.
• Knowledge of clinical documentation and study protocols.
• Strong organizational and communication skills.
• Attention to detail and time management abilities.
• Proficiency in Microsoft Word and Excel.

Responsibilities

• Assist in coordinating clinical trial activities and study timelines.
• Maintain clinical study documentation and essential records.
• Support clinical site activation and study startup activities.
• Track patient recruitment and enrollment progress.
• Assist in preparing clinical study reports and status updates.
• Coordinate with investigators, clinical research teams, and study sites.
• Maintain TMF documentation.
• Follow ICH-GCP guidelines and applicable regulatory requirements.

Skills

Clinical research basics

Documentation and protocols

Organizational skills

Attention to detail

MS Word & Excel

Tools

CTMS

EDC

eTMF

Job description

Job Title: Clinical Operations Associate

Type: Contract

Location: New Jersey

Experience: 0-2 years

Job Summary:

We are seeking a motivated Clinical Operations Associate to support clinical trial planning, coordination, and documentation activities in pharmaceutical, biotechnology, and medical device organizations. The candidate will assist in managing study records, tracking clinical trial progress, and coordinating with cross-functional research teams.

Key Responsibilities:

• Assist in coordinating clinical trial activities and study timelines.
• Maintain clinical study documentation and essential records.
• Support clinical site activation and study startup activities.
• Track patient recruitment and enrollment progress.
• Assist in preparing clinical study reports and status updates.
• Coordinate with investigators, clinical research teams, and study sites.
• Maintain Trial Master File (TMF) documentation.
• Follow ICH-GCP guidelines and applicable regulatory requirements.

Skills Required:

• Basic understanding of clinical research and trial operations.
• Knowledge of clinical documentation and study protocols.
• Strong organizational and communication skills.
• Attention to detail and time management abilities.
• Proficiency in Microsoft Word and Excel.

Preferred:

• Internship or academic project experience in clinical research.
• Familiarity with CTMS, EDC, or eTMF platforms.