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Job Summary: The Screening Coordinator (SC) works under the general direction and guidance of, and with the Study Managers or Study Directors and performs duties as directed to support the quality of projects.  The SC oversees the screening and enrollment phase of the project and prepares required documents to accurately capture all data required by a study protocol.

Essential Duties and Responsibilities:

The Statements made in the job description are intended to describe the general nature and level of work being performed by people assigned to this job.  These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.

• Reviews protocols to determine study specific inclusion/exclusion and study setup information. Evaluates for gaps in information and discusses omissions with project management and/or other departments to develop clear criteria.
• Develops screening tools and source documents to ensure adherence to the study protocol.
• Conducts the Informed Consent session by using the current approved version of the Informed Consent to study participants.
• Ensures each study participant 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.
• Ensures all study participants’ documentation is complete and adequately reflects their participation in the study screening process through enrollment. Ensures all subjects’ and screening failure documentation is kept with the study to meet good clinical and good documentation practices along with all applicable regulations.
• Ensures medical operations assesses all clinical labs, ECGs and other protocol tests as required.
• Follows progress of study participants and provides for their care, comfort, communication, and safety by attending to their needs during study participation.
• Oversees the progress of recruitment metrics and escalates potential concerns to the Study Manager or Study Director.
• Ensures subjects meet the study specific inclusion and exclusion criteria for enrollment into the study.
• Keeps abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines, state and national laws and ethical standards.  Seeks additional training, as needed, or required.
• Maintains professional working relationships with Sponsor representatives and internal colleagues within Spaulding Clinical Research.

The Statements made in the job description are intended to describe the general nature and level of work being performed by people assigned to this job.  These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.

Skills/Qualifications:

• Ability to read, write, and interpret the English language
• Demonstrated ability to lead by example and to encourage team members to seek solutions
• Excellent planning, organizational, and time management skills
• Excellent oral, written and presentation skills
• Ability to speak in front of an audience
• Demonstrates effective analytical, problem-solving skills
• Strong written and verbal communication skills
• Detail oriented
• 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
• Ability to function with multiple types of individuals in potentially difficult or uncomfortable settings
• Strong computer and skills; inclination to adopt technology to maximize efficiency                       

Physical Demands:

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 25 pounds.
• Specific vision abilities required by this job include clarity of vision both near and far. 
• Ability to identify and distinguish colors.

Hazards:

• Potential for exposure to toxic or caustic chemicals
• Potential for exposure to blood borne pathogens

Education and Experience:

• High / secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Accredited College or University degree desired
• Demonstrated knowledge of "Good Clinical Practices" and regulatory knowledge

 Spaulding Clinical Research management has the discretion to hire personnel with a combination of experience and education which may vary from the above listed skills and qualifications.