Senior Clinical Study Associate

Tundra Technical Solutions; Massachusetts; Hybrid; USD 110,208 - 117,096; Full time

Job summary

A leading clinical research company is seeking a Senior Clinical Study Associate III to support global clinical trial execution. This role is suitable for candidates with 3-5 years of clinical operations experience in the pharma industry and strong skills in document review. The position offers remote or hybrid work options.

Qualifications

• 3–5 years of clinical research or clinical operations experience, preferably in pharma.
• Experience supporting global clinical trials.
• Strong document review experience, especially for informed consent forms.

Responsibilities

• Support day-to-day clinical trial operations and enrollment tracking.
• Prepare and review key study documents.
• Ensure accurate tracking and filing of essential documents.

Skills

Clinical research experience

Document review

Presentation skills

Communication skills

Organization

GCP knowledge

Microsoft Office proficiency

Education

Bachelor’s degree in a relevant field

Job description

Tundra Technical Solutions provided pay range

This range is provided by Tundra Technical Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$80.00/hr - $85.00/hr

Direct message the job poster from Tundra Technical Solutions

Senior Clinical Study Associate III

Location: Remote or Hybrid (U.S.)

Category: Clinical Operations

We’re seeking an experienced Senior Clinical Study Associate III to support global clinical trial execution and ensure high-quality operational oversight across study sites. This role is best suited for candidates with pharma-side experience (not CRO-only backgrounds) and strong skills in document review and presentation.

What You’ll Do

• Support day-to-day clinical trial operations, including global site start-up, enrollment tracking, monitoring, and data flow.
• Prepare and review key study documents (e.g., informed consent forms, site instructions, study manuals, pharmacy binders).
• Ensure accurate tracking and timely filing of essential documents in the TMF; review site documents for completeness and accuracy.
• Track patient status and oversee key activities such as sample collection, lab reporting, and testing schedules.
• Liaise with clinical sites, central labs, vendors, and CRO partners to ensure proper sample handling and timely results.
• Review monitoring trip reports, track data queries, site metrics, and overall site performance.
• Participate in a limited number of site initiation, routine monitoring, and close-out visits; co-monitor as needed.
• Support investigator/vendor meetings and may present content.
• Contribute to study feasibility assessments and review site contracts and budgets.
• Coordinate third-party vendor activities including metrics, accruals, and operational planning.

What We’re Looking For

• 3–5 years of clinical research or clinical operations experience, with pharma industry experience strongly preferred.
• Experience supporting global clinical trials.
• Strong experience reviewing study documents, especially informed consent forms and operational materials.
• Excellent presentation, verbal, and written communication skills.
• Working knowledge of GCP and familiarity with clinical study phases.
• Proficiency in Word, Excel, PowerPoint, and database-related applications.
• Highly organized, detail-oriented, and strong at managing multiple priorities.

Education

• Bachelor’s degree or higher in a relevant scientific, healthcare, or technical field.

If you’re a collaborative, detail-oriented clinical operations professional ready for a fast-paced and impactful role, we encourage you to apply.