University - Research Coordinator II - Journeyman - Pediatrics: Research Group

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Job Description

Job Purpose: This position is for a Program Coordinator II that is under the direction of the Program Manger assuming responsibility and accountability in providing management of study related procedures for patients enrolled in Gene Therapy research studies.

Is responsible for all types of submissions required in maintaining Institutional Review Board (IRB) regulations and requirements for various types of clinical trials. Responsible for maintaining Investigator site files for all studies. Responsible for study start up with regulatory, budgeting and contract.

Guidance with the collection and entering all data from patient visits, answers query data in the EDC system for various types of clinical trials in a timely manner. Provides education to subjects in line with protocol requirements. Monitors and trains staff focusing on reporting adverse events as required per protocol, maintains screening, study visits, training and consent logs in Investigator site files.

Provides mentorship to junior staff members with areas of training and development regarding IRB submissions, staff training, conducting study visits, training in building relationships with monitors and sponsor/vendor personnel.

Facilitates necessary procedures required for gene therapy including but not limited to cryo-preservation, apheresis, radiology, and fertility banking. Position will also include coordination of home health services, transportation, and discharge care for study participants on a protocol specific basis.

This position may be eligible for partial remote work after an orientation period.

Duties:

Research Operations Research Visits-30%

Recruitment:
Synthesizes and interprets recruitment reports to assess effectiveness of recruitment strategies and implements innovative solutions to maximize recruitment strategies by allocating resources appropriately.

Screening:
Provides oversight and training to entire team unit with regards to subject screening. Establishes systems and policies related to subject screening.

Study visit preparation and documentation:
Provides oversight and training to study team members, including clinic staff, regarding preparation of study visits, maintenance of subject level documentation and creation of study level SOPs.

Conduct study visits:
Serves as a team resource and trains others regarding the conduct of study visits, creation of study level SOPs and implementation of operational plans. May perform advanced clinical assessments or interventions and trains others on study assessments.

Specimen collections:
Creates, optimizes, and oversees systems to collect, prepare, ship, and maintain inventory of research specimens and trains others on these tasks.

Informed consent:
Provides oversight (to include review) to study team members who conduct and document consent for participants in a variety of studies. Serves as an expert resource and trainer across department or unit on the consent process and related documentation.

Investigational Products:
Assists with management and tracking of IP at the protocol and subject level. Employs the required system for handling, dispensing, and documentation of IP for sponsored protocols. May be responsible for determining…