Associate Clinical Research Manager

About the Role

The Associate Clinical Research Manager assists with managing various aspects of assigned clinical trials involving patient and healthy subject populations in both inpatient and outpatient settings. The role acts as a liaison between senior project team members and study subjects, and involves actively participating and assisting with sponsor, investigator, and research team communications.

Key Responsibilities

• Actively participate with senior project team members to meet project needs, projections, and deadlines.
• Oversee organization and accuracy of project documents.
• Work with management on understanding departmental needs and improving processes.
• Provide support for the study conduct, working directly with the study monitor and study subjects.
• Oversee data entry, source data QC, EDC data entry and EDC query resolution, lab data verification, subject eligibility status review, and subject eligibility notification.

Requirements & Tech Stack

• Basic knowledge of Phase I processes and clinical study operations.
• Fundamental knowledge of FDA regulations and ICH GCP guidelines.
• Basic computer skills with working knowledge of Microsoft Office applications.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
• Time management and multi-tasking skills.
• Written and verbal communication skills.
• Ability to prioritize workload and adapt to changing study needs.
• Ability to act as a liaison between external and internal groups.

Working Conditions:

• Work is performed in an office, laboratory, and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments, and gloves.