Clinical Research Coordinator I

About the role

• Work Schedule
• Standard (Mon-Fri)
• Environmental Conditions

Able to lift 40 lbs. without assistance, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

About the role

Join us as Clinical Research Coordinator - And manage the day-to-day operations of our clinical trials.

What You'll Do

• Conduct multiple ongoing clinical trials, of varying size and complexity, involving patients or healthy volunteers/subjects.
• Complete all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the studyprocess. Interact with the research site team and other interdepartmental staff.
• Engage in the entire site operations process, which includes recruitment, enrollment and retention of study participants.
• Provide training and guidance to junior team members. Acts as a lead coordinator for certain studies, taking the overall responsibility thereof at the site, liaising with monitors and other stakeholders.

Education and Experience

• 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 5 years). 1+ year of leadership responsibility.

Additional information

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities

• Directly supervises individual contributors, administrative support and / or entry-level professionals.
• Fundamental communication and interpersonal skills with the ability to manage, motivate and mentor staff
• Strong organization skills with ability to handle multiple tasks simultaneously, meet rigorous timelines and work effectively in stressful situations
• Understanding of budgets, project planning and performance metrics
• Strong English and grammar skills, second language a plus
• Sound knowledge of taxonomies (e.g. folder structures, metadata, user access) and/or Records Management principles including but not limited to: FDA Good Clinical Practices; ICH Guidelines and PPDs Standard Operating Procedures and Working Practice Documents; retention schedules; Legal Holds; supporting software and/or PPD's eTMF process and the DIA eTMF Reference Model
• Sound knowledge of organization's archival processes and systems (hardware, software, applications, operating systems, basic programming languages, etc.)
• Ability to manage the day-to-day operation of Records Management file rooms including but not limited to document control, security and audit preparedness

Working Conditions and Environment

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequently drives to site locations and frequently travels both domestic and international.

Physical Requirements

• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Moderate mobility required.
• Occasional crouching, stooping, bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf. * Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacting with others, relates sensitive information to diverse groups both internally & externally.
• Ability to apply basic principles to solve conceptual issues.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.