Clinical Trial Associate

Clinilabs; United States; Remote; USD 70,000 - 73,000; Full time

Job summary

Clinilabs is seeking a Clinical Trial Associate to support the clinical study team with essential regulatory document review, TMF upkeep, and study status tracking. The role involves coordinating with PMs, LCRAs, and sites to ensure accuracy and compliance.

You will handle IRB submissions, TMF creation and archiving, and training of new staff. Some travel between company offices may be required.

Qualifications

• High School diploma or equivalent required.
• Some college or technical experience required.
• Bachelor’s degree preferred.

Responsibilities

• Timely and accurate review of essential regulatory documents (1572s, Informed Consents, Financial Disclosures, CVs) including communication of needed changes to PM, LCRA or site staff.
• Central IRB submission assistance.
• Tracking of study status.
• Maintenance of Clinical Trial Management System (CTMS).
• Creation, maintenance and archiving of trial master file (TMF).
• Shipment of study supplies.
• Meeting set-up and organization.
• Draft study meeting agendas/minutes.
• Liaise with Clinilabs’ clients as required per study.
• Site payment reconciliation assistance.
• Other study related administrative duties.
• Assist with training of new Clinical Trials Assistants.

Skills

GCP knowledge

FDA guidelines

Organizational skills

Communication skills

Team collaboration

Education

High School diploma or equivalent

Some college or technical experience

Bachelor’s degree preferred

Job description

The Clinical Trial Associate will be responsible supporting the clinical study team with administrative duties included but not limited to: collecting and reviewing essential regulatory documents, maintaining the trial master file and study status tracking.

RESPONSIBILITIES

• Timely and accurate review of essential regulatory documents (1572s, Informed Consents, Financial Disclosures, CVs) including communication of needed changes, as required, to PM, LCRA or site staff.


• Central IRB submission assistance.


• Tracking of study status.


• Maintenance of Clinical Trial Management System (CTMS).


• Creation, maintenance and archiving of trial master file (TMF).


• Shipment of study supplies.


• Meeting set-up and organization.


• Draft study meeting agendas/minutes.


• Liaise with Clinilabs’ clients as required per study.


• Site payment reconciliation assistance.


• Other study related administrative duties.


• Assist with training of new Clinical Trials Assistants.

Salary range between $70,000 - $73,000. Final compensation is based on skills, experience, location, and overall expertise.

TRAVELING

From time to time, travel between company offices may be required, as needed.

Requirements

• High School diploma or equivalent a must. Some college or technical experience required. Bachelor’s degree is preferred.


• At least 3-4 years of work experience in a clinical research role within a Pharmaceutical, Biotechnology Industry and/or CRO environment. In lieu of clinical research experience, at least 6 years in a health care setting.


• Knowledge of GCP guidelines, FDA guidelines, medical terminology and clinical trial processes.


• Strong organizational skills with attention to details.


• Excellent communication skills (written and verbal).


• Ability to manage and prioritize multiple tasks and projects.


• Ability to adapt to a fast-past and changing environment.


• Excellent interpersonal skills, ability to work in teams and in close collaboration with others.


• Ability to work independently and assist with improving the Clinical Trial Associate function and tools used by the person in this role.


• Ability to support Project Managers and drive the study start-up process, including feasibility, Informed Consent and TMF set-up.