SCREENING COORDINATOR

SPAULDING CLINICAL RESEARCH LLC•West Bend, WI

1d•$50,000 - $50,000•Onsite

About The Position

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.

Requirements

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
High / secondary school diploma or equivalent and relevant formal academic / vocational qualification
Demonstrated knowledge of "Good Clinical Practices" and regulatory knowledge

Nice To Haves

Accredited College or University degree desired

Responsibilities

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.