UNIV - Research Program Coordinator II Journey - Pediatrics: PRG

Job Description Summary

This position is for a Part-time Program Coordinator II who, under the direction of the PI and Program Manager, assumes responsibility and accountability in management of study related procedures for patients enrolled in taVNS BabySTrong II research studies.


Is responsible for the clinical trial information required in maintaining Institutional Review Board (IRB) regulations and requirements for this FDA regulated clinical trial. Responsible for maintaining the site files for all studies. Responsible for overall study site management with regulatory, enrollment, scheduling, study procedures, treatment, budgeting as well as communication with the other trial site study coordinator.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type​

Research Grant

Cost Center

CC001013 COM PEDS Children's Research Institute CC

Pay Rate Type

Hourly, Salary

Pay Grade

University-06

Pay Range

46,655.00 - 66,488.00 - 86,321.000

Scheduled Weekly Hours

20

Work Shift

Job Description

This position is for a Part-time Program Coordinator II who, under the direction of the PI and Program Manager, assumes responsibility and accountability in management of study related procedures for patients enrolled in taVNS BabySTrong II research studies. 

Is responsible for the clinical trial information required in maintaining Institutional Review Board (IRB) regulations and requirements for this FDA regulated clinical trial. Responsible for maintaining the site files for all studies. Responsible for overall study site management with regulatory, enrollment, scheduling, study procedures, treatment, budgeting as well as communication with the other trial site study coordinator.

In coordination with other research staff, will maintain and help perform a schedule for delivering taVNS paired with feeding twice daily for enrolled participants. Facilitates necessary procedures required for the study including but not limited to videofluoroscopic swallow studies; MRI/MRS; blood collection and plasma separation, alliquotting and storage in -80C freezer in SJCH; STEP developmental test; collecting parent-reported developmental questionnaires by phone or at clinic visit; collecting test-of-blinding questionnaires.  Position will also include coordination of pre- and post-treatment studies prior to discharge. 

Will enroll and consent participants along with PI and other coordinators. Guidance with the collection and entering all data from patient visits, answers query data in the EDC system for the 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. 

Job Duties:

Research Operations Research Visits: 35% 

Synthesizes and interprets recruitment reports (Screened subject/screen failures/enrollment) to assess effectiveness of recruitment strategies and implements innovative solutions to maximize recruitment strategies by allocating resources appropriately. 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 maintenance and editing of study level SOPs. Conduct study visits: Serves as a team resource and trains others regarding the conduct of study visits, creation/maintenance/editing 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 in the case report form (CRF). Employs the required system for handling, dispensing, and documentation of IP for sponsored protocols. May be responsible for determining the best methods for handling & documenting IP for investigator-initiated protocols and coordination with investigational pharmacies as necessary. Regulatory management:  Responsible for creating and/or implementing policies and procedures related to department/unit-wide regulatory management, as needed for the trial. Interactions with IRB: Serves as a department/unit-wide resource for the development of IRB submissions and for guidance on IRB communications. Preparation for study monitoring/audit visits: Responsible for creating and/or implementing research unit-wide policies and guidance related to monitoring and audits. Adverse event collection and safety reporting: Oversees adverse event collection and reporting to the PI or provides expert guidance on identifying adverse events. Safety Reporting: Oversees the IRB safety report documentation for the entire research unit. Serves as a resource to research unit and/or neonatology division on safety reporting. Billing Compliance: Serves as a resource and trains other staff on reviewing study participant charges and implementing corrective action plans. Ensures that the use of research funding is in compliance with funding agency protocols.

Data and Informatics-10%

Data Entry:  Serves as a divisional/unit-wide resource on CRFs, provides oversight to ensure highest quality data collection and capture. Data Coordination:  Creates complex data collection forms (CRFs and/or source documents) according to protocol.  Exports data to include reporting of data.

Communication-10%

Communication with sponsors, sites, study monitors, project managers & research team:  Prepares, participates, and/or leads team meetings.  Takes an active role in decision-making.  May be responsible for trouble-shooting issues and communicating with other team members accordingly.  Acts as an expert resource to junior staff liaising with sponsors, subcontractors, vendors or ancillary services. Site Specific Communications: Facilitates specific coordination with various departments including but not limited to radiology, speech, language pathology, occupational therapy, investigational pharmacy, and neonatal unit staff. 

Ethics and Participant Safety-5%

Safety Plans: Coordinates efforts and data for external monitoring boards and independently facilitates and submits the completion of documents related to Research Data Security Plans, Data Safety and Monitoring Plans, and Conflict of Interest. Implementation of Human Subjects Protections:  Serves as an expect resource to study teams as they design studies, so they specifically include safeguards to ensure ethical conduct and protection of vulnerable populations.

Leadership and Professionalism-5%

Management and mentorship:  Serve as a leader to entire division/research unit or leads a mentorship program within the division/research unit. Defines programmatic vision and direction.

Site and Study Management-35%

Trial Conduct:  Makes recommendations to investigators and oversight organizations regarding site resources for study teams to help determine efficiency of site trial conduct. Budgeting and Financial Management: Facilitates, reviews and confirms study budget and/or study invoices for study related activities and procedures including sub-contracts and billing.  Quality Assurance: Serves as an internal Quality Assurance Monitor and develops and implements protocol specific program quality assurance plans (such as double review of data entry, review and verification of outlier data, etc). Cooperates with the PI to conduct site-initiation, interim and close-out monitoring visits; cooperates with the site monitor on reviewing data and responding to queries, and helps draft responses to the monitoring reports, and develops corrective action plans related to visit findings. Managing Resources:  Oversees division/research unit wide processes related to research resources and finances.    Operational Plans:  Develops systems and documents including process flows, training manuals, and standard operating procedures to be used unit, department, or division-wide. Managing Risk:  Responsible for or leads the development and/or implementation of policies and guidelines related to compliance with institutional requirements and other policies.  Also ensures appropriate training of all staff related to risk management.  May also participate in or lead policy development and/or provide training at the institutional level.

Additional Job Description

Minimum Requirements: A bachelor's degree and two years relevant program experience. Physical Requirements: (Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) 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 20/40 vision, corrected, in one eye or with both eyes. (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)

If you like working with energetic enthusiastic individuals, you will enjoy your career with us!

The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.

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