Remote Clinical Trial Operations Associate

ProSciento, Inc; United States; Hybrid; USD 71,000 - 76,000; Full time

Job summary

ProSciento, Inc. is seeking a Clinical Trial Associate to support planning, execution, and delivery of single and multi-site trials in our CRO division.

You will work under the Clinical Team Manager and Study Startup Manager, serving as a subject matter expert for eTMF and CTMS systems. Ideal candidates hold a bachelor’s degree in health or biological sciences with about 1 year of clinical research experience, and possess knowledge of GCP, FDA regulations, and clinical software.

Qualifications

• Bachelor’s degree in health, biological science, or related field required.
• 1 year of clinical research or related experience preferred.
• Familiarity with regulatory requirements and clinical software.

Responsibilities

• Assist with study start-up activities and regulatory documentation.
• Support CTMS setup, regulatory packets, and site communications.
• Maintain CTMS/eTMF data and ensure proper document labeling.
• Coordinate shipment of lab kits, IP, and study materials to sites.
• Collaborate with CTM/SSUM on handover and study maintenance.

Skills

CTMS knowledge

eTMF systems

GCP regulatory knowledge

FDA regulations

MS Office

Education

Bachelor’s degree in health/biological sciences

1 year clinical research experience

Tools

CTMS software

eTMF familiarity

Job description

ProSciento, Inc. is seeking a Clinical Trial Associate to support planning, execution, and delivery of single and multi-site trials in our CRO division.

You will work under the Clinical Team Manager and Study Startup Manager, serving as a subject matter expert for eTMF and CTMS systems. Ideal candidates hold a bachelor’s degree in health or biological sciences with about 1 year of clinical research experience, and possess knowledge of GCP, FDA regulations, and clinical software.