Research Coordinator GCM Specialty Team

Advocate Health and Hospitals Corporation•Charlotte, NC

1d•Hybrid

About The Position

The Research Coordinator GCM Specialty Team is responsible for the clinical and administrative coordination of sponsored clinical trials, research protocols/projects, and biospecimen collection studies. This role provides guidance to physicians, clinical staff, and research team members, and acts as a liaison between sponsors and investigators. The coordinator will manage study start-up, IRB submissions, subject recruitment and enrollment, data collection, and close-out activities. They will also ensure laboratory requirements are met for specimen handling and facilitate quality assurance inspections and audits. Additionally, the Research Coordinator will develop and implement educational plans for research staff and investigators, review protocol amendments, and maintain competency in research computer applications.

Requirements

Bachelor's Degree in Biology, or Bachelor's Degree in Health Science, or Bachelor's Degree (or equivalent knowledge) in Nursing or related field.
Typically requires 2 years of experience in Research.
Knowledge of Good Clinical Practices, International Conference of Harmonization, FDA Guidance documents, Department of Health and Human Services regulations, standard operating procedures.
Ability to successfully conduct and manage a research study.
Ability to mentor team members and to prepare training plans.
Excellent verbal and written communication skills, organizational and time management skills with ability to work under pressure and meet deadlines.
Ability to problem solve and work independently with a high degree of accuracy and attention to detail.
Must be able to establish a good rapport with patients, investigators and sponsors.
Competency in using Electronic Medical Record (EMR), Microsoft Office Suite, and other computerized programs.

Nice To Haves

None Required.

Responsibilities

Performs clinical and administrative coordination of sponsored clinical trials, research protocols/projects, and biospecimen collection studies.
Provides guidance to physicians, clinical staff and research team members.
Coordinates assigned research studies in collaboration with other team members and key stakeholders, including but not limited to; study start-up, review of study CTA/budget/CTMS, IRB submissions, recruitment, screening, and enrollment of research subjects, development of mechanisms to maximize subject adherence to the research protocol, maintain source documentation, data collection (i.e. development, completion and submission of case report forms (EDC), study drug/device accountability, monitoring of subjects, AE/SAE reporting, study close out, and facilitates quality assurance inspections and audits.
Acts as a liaison between sponsor and investigators and as the primary protocol/project contact for team members and clinical staff.
Plans, develops and implements educational plans to disseminate protocol/project information with research staff, investigators and clinical staff.
Reviews protocol amendments and updates, research related orders (in collaboration with Investigational Drug Services), and study-specific workflows.
Ensures that laboratory requirements are being met for specimen procurement, proper collection, processing and shipment of specimens.
Serves as Primary Research Coordinator on studies across multiple sites guiding research team members involved in the study and coordinates and tracks research activities across sites.
Coaches and mentors research team members and other personnel.
Assist with implementation of educational training plans including orientation.
Maintains competency in research computer applications.
Attends and participates in educational programs, meetings, and assigned committees.
Licensed nurses will utilize advanced assessment skills to identify patient care problems, provide professional nursing care to research patients and support Research Coordinators in performing nursing activities as needed.

Benefits

Comprehensive suite of Total Rewards: benefits and well-being programs
Competitive compensation
Generous retirement offerings
Programs that invest in your career development
Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program