FLSA: Hourly

Job Summary: Under the direct supervision of the Vice Chair for Research and Program Coordinator II (PCII), the Program Coordinator I (PCI) will assist research investigators in the initiation, coordination, and management of clinical research trials and thus has a significant contribution to ensure assurance of sustainability, efficiency, and compliance. Assists with facilitating and coordinating the daily clinical trial activities and plays an active role in conducting the research studies. Exercises judgment regarding proper patient management, and provides support for the research investigators, faculty, fellows, PCII, and grants administrators.

Payscale Salary Range: UNIV-Band 5: $35,360.00 - $50,394.00 - $65,429.00 (min - mid - max)

Job Duties: 

• 30% - RESEARCH OPERATIONS – Study Visits 1. Synthesizes and interprets recruitment reports to assess effectiveness of recruitment strategies and implements innovative solutions to maximize recruitment strategies by allocating resources appropriately. 2. Screens participants for all studies independently (i.e screening for eligibility criteria). 3. Schedules study visits and maintains subject level documentation for minimal risk studies or for other studies under direct supervision. 4. Independently conducts study visits and may perform complex research assessments. Extracts complex data from electronic medical records. May train others to conduct study visits and perform protocol specific testing/interviews. 5. Conducts and/or documents consent for participants in a variety of studies independently. Applies knowledge of human subjects protection regulations in the informed consent process - (Essential)
• 10% - RESEARCH OPERATIONS – Regulatory 1. Maintains regulatory & training documents as required by Federal, State, Local, Institutional and protocol regulations & policies. 2. Creates a broad array of regulatory submissions (initial study applications) for minimal risk studies. Creates and submits simple regulatory reports (personnel amendments and continuing review applications) to the IRB. - (Essential)
• 10% - RESEARCH OPERATIONS – Administration 1. Corrects audit/monitor findings independently. 2. Collects, prepares or processes adverse events under supervision. 3. Under direct supervision submits reportable safety events to the IRB and/or Sponsor 4. Reviews study participant charges in the medical record and ensures the route according to the Study Billing Plan. - (Essential)
• 10% - DATA AND INFORMATICS 1. Completes case report forms and enters data into EDC system(s). Resolves data queries. 2. Creates and develops simple databases. 3. Assists with the creation of simple data collection forms (surveys, CRFs, and/or source documents). - (Essential)
• 10% - SCIENTIFIC CONCEPTS AND RESEARCH DESIGN 1. Performs literature reviews under direction of PI or supervisor. 2. Provides administrative assistance with grant proposals and applications. 3. Assists with organizing study results. - (Essential)
• 10% - COMMUNICATION 1. Prepares for and participates in team meetings. Serves as a primary liaison between Sponsor, PI, vendors, sub-contracts, and ancillary services including Investigational Drug Services Pharmacy, Lab, Imaging, NEXUS, and Hospital services, etc. 2. Assists with the preparation of publication manuscripts and maximizes available resources and contacts in both university departments and in the surrounding community that aid in dissemination. - (Essential)
• 10% - ETHICS AND PARTICIPANT SAFETY 1. Under direction provides data for external monitoring reports and/or facilitates completion of documents related to Research Data Security Plans, Data Safety and Monitoring Plans, and Conflict of Interest. 2. Understands the ethical conduct of research and safeguards needed when conducting human subjects research activities. 3. Under supervision, adheres to management plans related to conflict of interest. - (Essential)
• 5% - LEADERSHIP AND PROFESSIONALISM 1. Takes part in a committee, taskforce, or ad hoc group within a department. May participate in presentations and/or publications. - (Essential)
• 5% - Perform other assigned duties as required - (Essential)

Minimum Experience and Training Requirements: A bachelor's degree and one year relevant program experience.

Physical Requirements: Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/20 vision, corrected. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to perform gross motor functions with frequent fine motor movements. (Frequent)