Research Coordinator Ii

Job Description Summary

Entity

Medical University Hospital Authority (MUHA)

Worker Type

Employee

Worker Sub-Type​

Regular

Cost Center

CC004038 SYS - Project Lego

Pay Rate Type

Salary

Pay Grade

Health-29

Scheduled Weekly Hours

40

Work Shift

Job Description

The “In Our DNA SC” community health research project is designed to improve health care outcomes by integrating genetic insights into clinical care and research. The Research Coordinator II will provide technical and professional services within this statewide project. This position will assist the Principal Investigator (PI) involved in the coordination of human subject activities as delegated by the PI. Responsibilities may include the recruitment of study participants, coordinating collection events, and managing and maintaining up-to-date regulatory files.  The Research Coordinator II will act as a regulatory authority or advisor and as such, train, educate, or advise others within the project as appropriate.  The Research Coordinator II will function as a resource and mentor to the Research Coordinator I with all aspects and duties related to the success of the project.

Job Duties: 

• Serve as a study coordinator for In Our DNA SC. 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 and collect samples.
• Independently develops recruitment strategies, plans, and tools. Engages the community, physicians, and identifies barriers to recruitment. Screens participants, maintains subject level documentation for all studies, and may train others on Good Clinical Practice Guidelines related to study documentation. 
• May perform complex research assessments, extract complex data from electronic medical records and may train others on protocol specific items.
• Acts as a regulatory authority or advisor, or trains and/or educates others and/or advises research teams on regulatory matters, may manage 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 In Our DNA SC and trains other staff in these tasks. 
• Applies protocol and institutional guidelines to differentiate between reportable vs. non-reportable protocol deviations. 
• Completes case report forms and enters data into EDC systems(s). Resolves data queries. Exports data to include simple data analysis, and/or reporting of data. 
• Makes recommendations to investigators and oversight organizations regarding site resources and recruitment. Develops study protocol specific systems and documents including process flows, training manuals and standard operating procedures. Ensures study teams are compliant with institutional requirements/policies. Provides training to staff around these policies and ensures appropriate study specific training plans per the Delegation of Authority Logs.
• Identifies research barriers and takes part in a committee, taskforce, or ad hoc group to address. Develops tools to disseminate to other research teams. 
• Coordinates efforts and data for external monitoring visits. Employs safeguards for human subject protection and/or ensures vulnerable population regulations are adhered to and mitigated. Proactively identifies potential problems and risks to the participant, study investigator, research team, and institution and implements conflict management plans per regulations and institutional policies. 
• Prepares for and participates in team meetings. Serves as a liaison between Sponsor, PI, vendors, sub-contracts, and ancillary services including labs and MUSC Hospital services.
• Respond to inquiries in a timely matter (i.e. emails, phone calls, Epic messages).
• In addition to the duties explicitly mentioned in this job description, you may be required to undertake additional tasks and responsibilities as reasonably assigned by In Our DNA SC management. Such assignments will be within your skill and qualification levels and aligned with the overall objectives of the position. In Our DNA SC management will communicate any additional duties in a clear and reasonable manner, taking into consideration your workload and professional development.

Additional Job Description

A bachelor’s degree in related discipline and two years relevant clinical or clinical related or research related experience.  Preferred qualifications:  Strong organizational skills and attention to detail. Preferred knowledge of or proficiency in Outlook, EPIC, word processing, database, and spreadsheet software. Effective communication and interpersonal skills. Experience in regulatory affairs and clinical trials. Ability to work collaboratively in a team environment.  Flexibility to work in field settings and adapt to changing conditions. CITI training preferred or within 30 days of hire.

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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