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Location: Gainesville, Georgia
Internal Number: R7985
Northeast Georgia Health System is rooted in a foundation of improving the health of our communities.
The Trauma Research Coordinator is responsible for supporting the overall development and oversight of trauma research activities to meet the research requirements set forth by the American College of Surgeons (ACS) for Level I Trauma Center verification. He/She works closely with Trauma Services Leadership, the Trauma & Acute Care Surgery clinical team, Graduate Medical Education (GME) residents and research team members and the Northeast Georgia Health System Research Administration department to develop research projects and coordinate all aspects of the project with the goal of abstract submission and presentation, with eventual manuscript publication. This includes all phases of research: Study Initiation, Execution, Completion, and Administration.
Licensure or other certifications: Licensed to practice as a Registered Nurse in the State of Georgia.
Educational Requirements: Bachelors Degree in Nursing .
Minimum Experience: Five (5) years of nursing or clinical research experience.
Preferred Licensure or other certifications:
Preferred Educational Requirements: Masters degree in nursing, or science related field.
Preferred Experience: Two (2) years in project management and/or clinical research.
Knowledge of clinical research process
Excellent written and verbal communication skills
Advanced Computer Skills, including proficiency in Windows, Excel, Word, and competency with databases
Ability to work collaboratively and effectively as a team member and team leader
Project management skills
Remains current in knowledge and skills in clinical research and ACS research requirements for Level I Trauma Center verification
Ensures all research requirements for Level I Trauma Center verification are maintained.
Promotes use of Trauma Registry data for research projects.
Facilitates routine (monthly or more often) Trauma Research meetings with participating stakeholders.
Provides quarterly Trauma Research reports to the Multidisciplinary Trauma Systems/Operations Committee (MTSOC) to include current research projects and recent publications.
Engages Trauma & Acute Care Surgery clinicians and other surgical specialists in trauma research projects.
Oversees all phases of trauma related research including: Study Initiation, Execution, Completion, and Administration (detailed below).
Study Initiation: Plan, organize, implement clinical trials/research studies to effectively meet goals and ensure timely completion of the study. Manage and communicate effectively with Trauma Program Manager regarding proposed projects for feasibility, including, analyzing scope of work, cost and responding to inquiries and/or complaints. Review protocol for potential operational issues and make recommendations, as needed. Create informed consents. Submit protocol, informed consents and necessary documents to IRB for approvals; communicate with IRB on a regular schedule if applicable. Attend IRB meetings for protocol review, as needed. Confirm that all regulatory documents are submitted to sponsor in a timely manner, e.g., 1572, Confidentiality Agreement, clinical trial agreements, IRB approval letter, Financial Disclosures, etc., as needed. Ensure the staff CVs and licenses are current. Communicate with Trauma Program Manager regarding study initiation needs. Identify needed storage space for study product. Develop study specific materials, e.g., tracking logs, templates, monitoring tools, source documents, study binders, process manuals.
Study Execution: Screen potential subjects for enrollment. Explain protocol and informed consents to subject and obtain informed consents for subject participation. Oversee patient enrollment and follow-up. Be available for study "call" if needed. Maintain strong working knowledge of SOPs, FDA regulations, and ICH/GCP guidelines. Complete CRFs and study related documents, submit documents to sponsor and/or IRB, if applicable. Ensure sponsor required documents are completed, e.g., screening logs, A/E forms, memo to file, etc. Plan, organize, and participate in site initiation visits and continued monitoring visits. Ensure studies are completed on time and within budget. Communicate with outside vendors such as central laboratories, central IRBs, etc. Analyze and/or report safety issues, patients care issues, and study design and/or study conduct issues. Ensure that Adverse Events (AE) and Serious Adverse Events (SAE) procedures are followed accurately and within federal regulations and sponsor guidelines. Prepare study reports, e.g., modification, amendments, IND reports, etc. Perform yearly review of studies, completing yearly documents required by sponsor, IRB and FDA. Review case report forms. Audit regulatory binders. Ensure timely and accurate communication with the sponsor, among research staff, and with the multiple functional areas with Institution, e.g., via regularly scheduled calls, team meetings, etc. Complete status reports and communicate with the sponsor, research staff, Trauma Program Manager and Investigator(s). Work with the key functional departments to coordinate the project-related activities to meet project goals and milestones, based on the study design. Ensure study data is submitted on-time to data management for analyses. Ensure the statistical analysis plan is complete, if applicable. Ensure information is available for final study report completion.
Study Completion. Complete study close out procedures. Submit closeout documents to sponsor and IRB. Return study product, if applicable. Submit yearly post study documents, as required. Ensure study material are stored and maintained for appropriate time line.
Administration: Strong knowledge of MS Word, Excel, PowerPoint and Outlook. Demonstrate ability to prioritize multiple projects. Proven ability to independently resolve problems. Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines. Work in a fast paced environment with demonstrated ability to perform multiple competing tasks and demands. Work independently, take initiative and complete tasks to deadlines.
Participate in the training of other research staff as assigned.
Track project milestones and report progress and issues to Trauma Program Manager and Primary Investigator.
Create and promote positive team morale.
Read professional journals and publications to stay abreast of regulations and study management and to learn scientific area.
Serve as a department resource for general study related issues.
Create and/or deliver project specific training to ensure adequate training specific to project requirement, e.g., project overview, study protocol information.
Performs other related job duties or functions as requested or assigned.
Weight Lifted: Up to 50 lbs, Occasionally 0-30% of time
Weight Carried: Up to 20 lbs, Occasionally 0-30% of time
Vision: Moderate, Frequently 31-65% of time
Kneeling/Stooping/Bending: Occasionally 0-30%
Standing/Walking: Occasionally 0-30%
Pushing/Pulling: Occasionally 0-30%
Intensity of Work: Occasionally 0-30%
Job Requires: Reading, Writing, Reasoning, Talking, Keyboarding, Driving
Working at NGHS means being part of something special: a team invested in you as a person, an employee, and in helping you reach your goals.
NGHS: Opportunities start here.
Northeast Georgia Health System is an Equal Opportunity Employer and will not tolerate discrimination in employment on the basis of race, color, age, sex, sexual orientation, gender identity or expression, religion, disability, ethnicity, national origin, marital status, protected veteran status, genetic information, or any other legally protected classification or status.
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