**Entity/Organization: MUHA (Medical University Hospital Authority/Medical Center)**
**Hours per week:** 40
**Scheduled Work Hours/Shift:** Monday through Friday, day shift
**Fair Labor Standards Act Status:** Salaried
**Job Summary/Purpose** :
Serve as the lead study coordinator in clinical trials. Act as the local point of contact from study conception to close-out. Communicate closely with genetic counselors and providers as needed. Obtain informed consent, screen and enroll study participants per study inclusion and exclusion criteria to meet study contract enrollment, conduct study visits as per protocol, coordinate patient visits, provide education to subjects, monitor adverse events and prepare serious adverse event reports, collect and process lab samples, dispense study medication to patients, conduct patient diary reviews, enter data and complete case report forms.
**Minimum Training and Education:** A bachelors degree and two years relevant program experience.
**Additional Duties and Responsibilities:** Independently develops recruitment strategies, plans, and tools. Engages the community, physicians, and identifies barriers to recruitment. Screens participants for all studies independently, maintains subject level documentation for all studies independently, may train others on Good Clinical Practice Guidelines related to study documentation. Conducts study visits and may perform complex research assessments, extracts complex data from electronic medical records and may train others on protocol specific testing/interviews, Conducts and/or documents consent for participants in a variety of studies independently applying knowledge of human subject s protection regulations in the informed consent process. Acts as a regulatory authority or advisor, or trains and/or educates others and/or advises research teams on regulatory matters, may manage multi-site regulatory documents independently. Creates regulatory submissions and annual reports to regulatory authorities and funding agencies (NIH, FDA, etc. ) and completes required supplemental regulatory documents (IND/IDE, Certificate of Confidentiality, etc.) for all studies and trains other staff in these tasks. Acts as a liaison for multi-site studies, managing regulatory submissions and reporting across all participating sites and with the IRB of record. Assists with management and tracking of Investigational Products (IP) at the protocol and subject level employing required systems for handling, dispensing, and documenting IP for investigator-initiated protocols. Collects, prepares, ships, and/or maintains inventory of research specimens and provides guidance on system improvements related to specimen handling. Corrects audit/monitor findings independently. Collects, prepares, or processes adverse event information independently Completes IRB and/or Sponsor reportable events independently. Applies protocol and institutional guidelines to differentiate between reportable vs. non-reportable adverse events. Reviews study participant charges, identifies discrepancies and escalates to appropriate offices to ensure billing compliance.
**Physical Requirements:** Ability to perform job functions while standing. (Continuous) Ability to perform job functions while sitting. (Continuous) Ability to walk. (Frequent) Ability to climb stairs. (Infrequent) Ability to work indoors. (Continuous) Ability to work outside in temperature extremes. (Infrequent) Ability to kneel. (Infrequent) Ability to bend at the waist. ( Infrequent) Ability to twist at the waist. (Infrequent) Ability to squat. (Infrequent) Ability to reach. (Frequent) Ability to lift/carry 15 lbs. unassisted. (Frequent) Ability to lift/lower objects 15 lbs. from/to floor from/to 36 inches unassisted. (Infrequent) Ability to lift from 36 inches to overhead 15 lbs. unassisted. (Infrequent) Ability to move objects from floor level to 36 inches height weighing to 15 lbs. unassisted. (Infrequent) Ability to move from height of 36" to floor objects weighing to 15 lbs. unassisted. (Infrequent) Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous) Ability to see and recognize objects close at hand or at a distance. (Continuous) Ability to determine distance/relationship between objects; depth perception. (Continuous) Ability to see and recognize objects at a distance. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to perform gross motor functions with frequent fine motor movements. (Continuous) Ability to work in a latex safe environment. (Continuous) Ability to be qualified physically for respirator use, initially and as required. (Continuous)