Position Summary:

The Assistant Study Coordinator position is responsible for providing administrative support to the Study Coordinators. The position will work with the Study team to assist in executing clinical study activities. The Assistant Coordinator is responsible for preparing clinical trial related documents and the execution of tasks performed while ensuring that clinical activities are in compliance with study protocols, GCP and SOPs. This position reports into the Study Management Manager.

Position Responsibilities

Ensure the confidentiality of clinical research volunteers and sponsors

• Maintain and advocate a high level of customer service and quality within the department
• Assist in the maintenance of Clinical Conductor
• Maintain the ERP system including preparing, filing, assisting with updates and archiving study related information
• Prepare, handle, distribute, track and maintain clinical trial related supplies
• Assist with educating study volunteers on study procedures such as diary completion, electronic devices and expected outcomes in a profession and accountable manner following protocol requirements.
• Assist in tracking volunteer visits in Clinical Conductor, rescheduling as needed and update study coordinators in a timely fashion regarding missed visits or compliance issues.
• Perform protocol specific activities including but not limited to medical history, vital signs, electrocardiograms and specimen collection.
• Record adverse events and concomitant medication use and follow-up on open adverse events until through resolution.
• Obtain and document study related events and data in compliance with GCP/SOPs
• Communicate necessary volunteer information in a timely manner to study coordinator/PI on an ongoing basis.
• Assure source documents/charts are prepared for future study visits.
• Proactively communicate issues and or problems to the Senior Study Coordinator
• Other duties as assigned

Experience and Skills:

• Excellent communication, interpersonal, analytical and problem-solving skills
• Microsoft Office Suite proficiency
• Writing and verbal communication skills
• Knowledge of medical terminology and concepts
• Familiarity with electronic case report form systems such as Medidata Rave, Inform, TrialKit,etc.
• Strong study documentation skills in compliance with ALCOA+
• Proficient typing and data entry skills
• Ability to work effectively with a team
• Ability to manage small projects personally and work independently
• Memory to retain information and know where to research answers
• Time management skills
• Organizational skills
• Detail oriented with the ability to perform at a high level of accuracy
• Demonstrates strong analytical, problem solving skills
• Self motivated
• Must be results oriented, multi-tasking, quick learner
• Respond to the urgent needs of the team and show a strong track record of meeting deadlines

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel
• Ability to lift and/or move up to 20 pounds

Education and Experience:

• High school diploma or GED is required; Bachelor’s degree is preferred
• Experience in a clinical research setting ore related work environment is preferred
• Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)
• Familiarity with or ability to learn clinical trial management system software

The above is not an exhaustive list of duties and you will be expected to perform different tasks as necessitated by your changing role within the organization and the overall business objectives of the organization.