Work Schedule

Environmental Conditions

Job Description

Job Overview:
 
Under the general direction of the Clin Ops Supervisor, the Screening Coordinator I is responsible for the successful completion of the screening phase of all early and late phase trials within the Clinical Research Unit. This entails, but is not limited to, conducting a screening session to provide the Informed Consent session as delegated by the Principal Investigator. Prepares all requires paperwork (source documents, lab requisitions, supplies, eligibility packet and any other screening related items required to capture all data within the protocol. Thoroughly reviews inclusion and exclusion requirements to ensure all study participants meet requirements of the protocol.  
 
Essential Functions:
 
Reviews protocols to determine study specific inclusion/exclusion information. Evaluates for gaps in information and discusses omissions with Supervisor and Clinical Research Manager to develop clear criteria.
 
Requests screenings appointments for participants. Considers the number of appointments and times of screenings and physicals to meet study needs. Arrives 30 minutes prior to scheduled screening with complete screening paperwork for the required number of screening participants.
 
Conducts the Informed Consent session by reading aloud the designated primary focus points of the most recently approved version of the Informed Consent to volunteers while the volunteers follow along with their own copies.
 
Ensures each subject screened has been properly consented, has a signed informed consent, and all questions answered prior to any procedures being performed and continuing in the screening process with a good understanding of all methods of consent capture.
 
Ensures all study participants’ paperwork is complete and adequately reflects their participation in the study screening process. Ensures all subjects’ and screening failure paperwork is kept with the study to meet FDA requirements.
 
Ensures physician reviews all clinical labs, ECGs and other tests as required and keeps Clinical Research Manager appraised of recruitment information.
 
Develops screening tools and source documents to ensure adherence to all inclusion/exclusion criteria. Fully utilizes all internally required forms, checklists and tracking sheet to ensure excellent management of participants throughout screening process.  
 
Qualifications:
 
Education and Experience:
 
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
 
Previous applicable experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
 
In some cases, a combination of appropriate education, training and/or directly related experience will be considered sufficient and equivalent for an individual to meet the requirements of the role.
 
Knowledge, Skills and Abilities:
 
Demonstrated ability managing multiple responsibilities and completion of projects with overlapping prioritization.
 
Basic computer skills including knowledge of Microsoft Office and the ability to learn various programs and/or data management or electronic source systems.
 
Strong communication skills. Ability to clearly explain information to a wide variety of individuals.  
 
Ability to work closely with multiple types of individuals in potentially difficult or uncomfortable settings.
 
Strong attention to detail with strong planning and organization capabilities to manage multiple tasks and multiple study groups at one time.
 
Effective time-management while demonstrating ability to communicate need for assistance.
 
Management Role:
 
No management responsibility.
 
 
Working Conditions and Environment:  
 
Work is performed in an office or clinical environment. 
 
Frequent long hours, weekends, and/or holidays. 
 
Exposure to blood and biohazardous waste. 
 
Be available by cell phone after hours. 
 
Potential occasional travel required. 
 
 
Physical Requirements: 
 
Frequently vertical and /or 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.  
 
Frequent mobility required.  
 
Frequent 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 moderately complex 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 interacts with others, relates sensitive information to diverse groups.  
 
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. 
 
 
This document is intended to describe the general nature and level of work being performed by this job. This document is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. Individual responsibilities will be defined by your leadership team and will vary based on business needs.