Provides lead administrative support to the research sites, executing and ensuring completion of all activities of the team by coordinating and assisting patients and visitors visiting the site. Acts as the firstline contact for patients and visitors. Ensures high standards of service and an outstanding patient experience in relation to communication, information and engagement with patients.
Coordinates, oversees and provides direction for the completion of administrative functions on assigned trials.
Welcomes patients and all visitors upon arrival at the site.
Completes data entry and visit completion information and manage the diary
system, ensuring data is accurate and up to date at all times.
Schedules patients for follow-up visits, external appointments, transport, etc.
Conducts reminder telephone calls to patients to confirm visits.
Prepares all relevant patient documentation as per protocol and local regulations ahead of appointment.
May collect medical history information for potential patients, liaising with
medical facilities and networks to collect patient files, documentation and other
relevant information as may be required as per protocol.
Collects and tracks patient notes, lab results and questionnaires to facilitate
prompt reviewing.
Assists with the collection of patient SDV from local medical professional.
Maintains a presentable, safe and clean reception area to enhance the patient
and visitor experience.
Completes or provides guidance to ensure completion of photocopying, faxing,
postal activities, archiving and patient refreshments.
May provide support in the Pharmacy in all areas of drug administration. Assists
with deliveries, checking stock and monitoring inventory of the dispensary.
Assists with collating files, counting IP returns and ensuring compliance to
company SOPs and COPs.
May assist with the education, evaluation, treatment and follow-up of sleep
disorders for clinic patients. Performs comprehensive sleep testing and analysis on clinic patients per study protocol.
Completes reimbursements of patient study expenses and payments
Collaborates with other site functions to provide accurate and streamline
processes and participate in best practice/process improvement initiatives
ensuring standardized approach.
Ensures compliance with company quality framework, regulatory (GCP)
legislation, guidelines and international standards (Global/Local COPS & SOPS)
Good understanding of Good Clinical Practices (GCP), with ability to learn and maintain a good working knowledge of FDA regulations and company/client SOPs and WPDs
Solid organizational skills and flexibility to manage workload and meet changing timelines
Firm attention to detail to ensure accuracy and efficiency in data entry
Solid interpersonal/customer service skills, positive attitude, and good oral and written communication
Capable of working in a team or independently
Solid English language and grammar skills
Good computer skills, including proficiency in MS Office (Word, Excel, and PowerPoint) and basic understanding of clinical trial database systems
Good analytical and data management skills to effectively analyze data/systems to ensure accuracy and efficiency
BLS or CPR certification
Ability to multi-task and ability to have oversight over a few studies with a number of participants simultaneously
Strong attention to detail
Working knowledge of medical terminology is an advantage
Frequently stationary for 4-6 hours per day.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
Occasional 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.
Ability 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.
May interact with others, relating and gathering sensitive information. Interaction includes diverse
groups.
Works with guidance or reliance on oral or written instructions from management. May require
periods of intense concentration.
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.
