location_0_addressRegionName

location_0_addressCountryName

OFFSITE

PERMANENT

FULL_TIME

jobPosting hiringOrganization as json hashed.

ADAPTED_NOW

UNKNOWN

YEAR

Research and Development Coordinator

Evaluate IRB requirements for each protocol for completeness, guiding appropriate completion by investigator and appropriately submit and track progress of protocols, informed consents and any necessary documents to Institutional Review Board (IRB) for study determination and/or approvals; communicate with IRB if applicable. Prior to implementation, carry out a needs and resources assessment on the protocol and meet with appropriate service groups/vendors to design and confirm a resource plan and timeline to maximize efficiency of NGHS/study resources in a strategic interdependent manner.

KBSkills

ACTIVE

Job Category:Research & Research AdministrationWork Shift/Schedule:8 Hr Morning - AfternoonNortheast Georgia Health System is rooted in a foundation of improving the health of our communities. About the Role: Job Summary Responsible for the coordinating, implementing, tracking and evaluating NGHS research studies. This includes all phases of the research cycle:<ul><li>Study and Protocol Design, Feasibility and Implementation</li><li>IRB, Ethical and Data Review</li><li>Administration, Recruitment, Data collection</li><li>Data analyses</li><li>Completion</li><li>Formal Closure</li><li>Maintains appropriate and accurate documentation of study files as well as patient/study participant consent and evaluation data.</li><li>Leads, coordinates or guides strategies for recruitment of study participants, enrollment of participants, and manages data collection and reporting for institutionally approved research studies.</li><li>Ensures the requirements are met for subject enrollment and compliance from entry through follow up, investigator participation, data report submission and audits.</li><li>Responsible for management of assigned grant projects.</li><li>Responsible for ensuring all research stages are in compliance with all regulatory requirements as outlined in NGHS policies, local, state and Federal 45CFR46. </li></ul> Minimum Job Qualifications <ul><li>Licensure or other certifications: Clinical Research Coordinator or Equivalent Certification (or completed within 2 years of hire); CITI certification or equivalent Human Subjects Research Training (or completed within 60 days of hire).</li><li>Educational Requirements: Masters Degree</li><li>Minimum Experience: Minimum of five years experience in healthcare research, public health research and/or academic science or PhD in related area, and evidence of two years experience with healthcare research study design. </li><li>Other: Masters Degree (with research or dissertation component) in Health Sciences, Educational research, life sciences.</li></ul> Preferred Job Qualifications <ul><li>Preferred Licensure or other certifications: Certification or evidence of skills in database management, data analysis. Certification in Grant Writing and or Grant Management.</li><li>Preferred Educational Requirements: PhD</li><li>Preferred Experience: Experience with statistical analysis in healthcare applications.</li><li>Other:</li></ul> Job Specific and Unique Knowledge, Skills and Abilities <ul><li>Thorough knowledge of processes involved in rigorous healthcare research and departmental specific accreditation requirements.</li><li>Excellent written and verbal communication skills.</li><li>Advanced Computer Skills, including proficiency in Windows, Excel, Word, and competency in managing data within large databases.</li><li>Remains current in knowledge and skills in healthcare research, and research ethics.</li></ul> Essential Tasks and Responsibilities <ul><li>Ensures compliance with IRB approved recruitment, screening and consenting procedures, identifies preliminary cohorts, recruits and screens potential study participants</li><li>Facilitates the development of study-related training for study stakeholders as required in protocol, and coordinates the deployment of the sessions, running these if needed.</li><li>Provider and staff research skills education:Develop engaging educational content to address specified outcomes for current stakeholders, and potential stakeholders at all levels of NGHS. </li><li>Works with relevant data developers, analysts, data scientists and statisticians to collect, organize and manage study relevant data in a structure that aligns with NGHS IT data collection standards. Secures data in compliance with institutional and local, state and Federal requirements as well as study sponsor requirements. Acts as super user and trainer of NGHS data collection and analysis assets. </li><li>Coordinates and collaborates in collection of departmental specified metrics in a timely and accurate manner, presenting these metrics in a digestible manner for each stakeholder group as set out in departmental standard work.</li><li>Follows program required standard work and research study processes. </li><li>Study Initiation (Study Assessment, Development, and Approval)</li><li>Helps to identify potential cohort numbers (sample frame) through patient cohort development, manages feasibility study, or pilot test as appropriate. Helps coordinate study start up activities. For each activity, the coordinator is responsible for project management of all aspects of the process in line with the approved protocol, including grant sponsored and clinical trial projects</li><li>Manage and communicate effectively with Research Leadership regarding proposed projects for feasibility, including analyzing scope of work, cost and responding to inquiries and/or complaints</li><li>Prior to implementation, carry out a needs and resources assessment on the protocol and meet with appropriate service groups/vendors to design and confirm a resource plan and timeline to maximize efficiency of NGHS/study resources in a strategic interdependent manner. Review protocol for potential operational issues, and make alternate recommendations, as needed.</li><li>Using knowledge of institutional, local, state and Federal research related informed consent requirements, ensure consent documentation and described processes are compliant according to appropriate guidelines.</li><li>Evaluate IRB requirements for each protocol for completeness, guiding appropriate completion by investigator and appropriately submit and track progress of protocols, informed consents and any necessary documents to Institutional Review Board (IRB) for study determination and/or approvals; communicate with IRB if applicable. Add IRB submission to NGHS IRB tracker and update with approvals. Securely store IRB communication, modifications, approvals etc. in program approved manner. Assist investigators in IRB protocol reviews as necessary.</li><li>Attend IRB meetings for protocol review, as needed</li><li>Confirm that all required and /or regulatory documents are submitted to sponsor / securely stored in a timely manner, e.g., 1572, Confidentiality Agreement, clinical trial agreements, IRB approval letter, Financial Disclosures, etc., as needed.</li><li>Maintain current study team member resumes, CITI certifications, study-specific training and licenses are current. </li><li>Communicate with Research Leadership regarding study initiation needs, updates central research tracker on a timely basis. Schedules and monitors approved implementation tasks and timeline. </li><li>Coordinator tracks and documents progress through each stage of the protocol, ensuring that the personnel identified and approved by the PI and listed in the protocol adhere to the protocol, reporting any variances, deviation, or barriers noted to the PI in a timely fashion.</li><li>Research documentation environment and hard research study assets: Ensure use of approved, secure, digital and building storage space for any study documentation, data storage, device, or product storage. Ensure appropriate maintenance is carried out on device and products used including cleaning and calibration by approved vendors.</li><li>Study Execution (data collection, analysis, disseminationand completion phases)</li><li>Ensure that the approved recruitment, screening and consent processes are adhered to for cohort defining and participant enrollment. </li><li>Securely retain study documentation and report any deviations from approved protocol to the study team and principal investigator. Report any variance following institutional standard policies.</li><li>Collaborate with approved stakeholders, and oversee specified data management process, providing progress reports to PI and co-investigators.</li><li>Ensure all phases of data management process are adhered to, and documented. Reporting variances or deviations to Department Director and PI.</li><li>Maintain strong working knowledge of Standard Operating Procedures (SOPs), FDA regulations and developing data management standards</li><li>Update central project tracker on a timely basis. Complete Case Report Forms (CRFs) and Study related documents, submit documents to sponsor and or IRB, if applicable. Including interim reports for awarded grant projects, financial summaries as required.</li><li>Ensure sponsor required documents are completed, e.g., screening logs, Adverse event (A/E) forms, memo to file, etc. Inform Program Director of variances or expected barriers.</li><li>Plan, organize, and participate in accreditation site visits, site initiation visits and continued monitoring visits.</li><li>Review research progress tracker and applicable monitoring reports with the Research Department Team, ensuring that the Program Director is aware of variances, barriers, and opportunities for innovation.</li><li>Ensure studies are completed on time and within budget by maintaining a detailed and up to date financial statement. Report any recommendations or expected, experienced variances to the program director in a timely fashion.</li><li>Communicate with outside vendors such as device vendors, grant awarding bodies, data mart developers, central laboratories, central IRBs, etc.</li><li>Provide guidance and troubleshoot issues, documenting these in the research management notes, communicating these to the program director. Proactively address study concerns and develop timely resolutions.</li><li>Present at internal and external events - academic presentations, professional research conferences and promotion events</li><li>Prepare interim report for PI, coordinate the documentation, reporting and analyses of safety issues, patients care issues, and study design and/or study conduct issues to the PI and on approval, appropriate IRB, sponsor and Program Director, as per department process. </li><li>Ensure that Adverse Events (AE) and Serious Adverse Events (SAE) procedures are followed accurately and within federal regulations and sponsor guidelines.</li><li>Prepare study reports as requested by PI, e.g., modification, amendments, funding requirements, resource needs assessment, Investigational New Drug (IND) reports, etc.</li><li>Perform required review of studies, completing yearly documents required by grant issuer, sponsor, IRB and FDA.</li><li>Provide guidance and editing services to non clinical trial investigator study manuscripts, ensuring ethical authorship and citation standards are adhered to.</li><li>Audit and maintain study and regulatory binders, grant documentation both hard and digital copies and report any gaps to the PI.</li><li>Ensure timely and accurate communication with the project stakeholders including sponsors, investigators, among research staff, and with the multiple functional areas with Institution, e.g., via regularly scheduled calls, team meetings, etc. Document these appropriately, including attendance. </li><li>Complete status reports and communicate with the sponsor, research staff, Research Manager and Investigator(s). Update central progress tracker.</li><li>Work with the key functional departments to coordinate the project-related activities to meet project goals and milestones, based on the study design.</li><li>work with investigators to ensure study data is submitted on-time to data management for analyses, and coordinate any data validation meetings with the data developer.</li><li>Ensure the statistical analysis plan is complete, if applicable.</li><li>Ensure information is available for final study report completion.</li><li>Performs related responsibilities as required</li></ul> Physical Demands <ul><li>Weight Lifted: Up to 20 lbs, Occasionally 0-30% of time</li><li>Weight Carried: Up to 20 lbs, Occasionally 0-30% of time</li><li>Vision: Moderate, Frequently 31-65% of time</li><li>Kneeling/Stooping/Bending: Occasionally 0-30%</li><li>Standing/Walking: Frequently 31-65%</li><li>Pushing/Pulling: Frequently 31-65%</li><li>Intensity of Work: Occasionally 0-30%</li><li>Job Requires: Reading, Writing, Reasoning, Talking, Keyboarding, Driving</li></ul>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.

Northeast Georgia Health System, Inc

Coordinator-Multidisciplinary Research

Academic Research

Adverse Events

Biology

Budget Management

Calibration

Clinical Trial

Code of Federal Regulations

Communication Skills

Computer Skills

Cross-Functional

Data Analysis

Data Collection

Data Management

Data Mart

Data Quality

Data Science

Data Storage

Data Structures

Database Administration

Documentation

Drug Development

Editing

Environmental Research

FDA Requirements

Feasibility Analysis

Federal Laws and Regulations

Financial Disclosure

Financial Reporting

Financial Statements

Follow Through

Funding

Grant Administration/Management

Grant Awards

Grant Writing

Health Education

Health Science

Healthcare

Healthcare Software

IRB/IEC (Institutional Review Board/Independent Ethics Committee)

Identify Issues

Information/Data Security (InfoSec)

Investigational New Drug (IND)

Laboratory

Leadership

Lift/Move 20 Pounds

Maintain Compliance

Metrics

Microsoft Excel

Microsoft Windows Operating System

Microsoft Word

Needs Assessment

Organizational Skills

Patient Assessment

Patient Care

People Management

Physical Demands

Pre-Clinical Trials

Presentation/Verbal Skills

Problem Solving Skills

Progress Reports

Project/Program Coordination

Project/Program Management

Protocol Analysis

Protocol Design

Public Health

Recruiting Strategy

Regulatory Compliance

Regulatory Requirements

Regulatory Submissions

Reporting Skills

Research Administration

Research Skills

Scientific Research

Site Initiation

Standard Operating Procedures (SOP)

Standards Development

Startup

Statistics

Status Reports

Time Management

Training/Teaching

Writing Skills

monster

Research Nurse

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. Coordinates strategies for recruitment of study participants, enrolls participants, and manages data collection and reporting for institutionally approved research studies.

Job Category:Nursing - Registered NurseWork Shift/Schedule:8 Hr Morning - AfternoonNortheast Georgia Health System is rooted in a foundation of improving the health of our communities. About the Role: Job Summary Responsible for the coordinating, implementing, and evaluating of clinical research trials. This includes all phases of research:Study Initiation, Execution, Completion, and Administration. Maintains appropriate and accurate documentation of patient/study participant evaluation data. Coordinates strategies for recruitment of study participants, enrolls participants, and manages data collection and reporting for institutionally approved research studies. Ensures the requirements are met for subject enrollment and compliance from entry through follow up, investigator participation, data report submission and audits.   Minimum Job Qualifications <ul><li>Licensure or other certifications: Current GA RN License.</li><li>Educational Requirements: Associates Degree.</li><li>Minimum Experience: One (1) to two (2) years direct clinical RN experience. Less than one (1) year RN experience may be acceptable after Management review of experience and credentials. </li><li>Other:</li></ul> Preferred Job Qualifications <ul><li>Preferred Licensure or other certifications: Clinical Research Certification or scheduled exam date.</li><li>Preferred Educational Requirements: </li><li>Preferred Experience:</li><li>Other:</li></ul> Job Specific and Unique Knowledge, Skills and Abilities <ul><li>Thorough knowledge of Clinical Research Process</li><li>Excellent written and verbal communication skills</li><li>Advanced Computer Skills, including proficiency in Windows, Excel, Word, and competency with databases</li><li>Remains current in knowledge and skills in clinical research ​</li></ul> Essential Tasks and Responsibilities <ul><li>Recruits and screens potential study participants.</li><li>Develops and conducts patient and family education regarding research participation as it relates to diagnosis, treatments, and protocol specifications.</li><li>Performs subject evaluations, administers investigational product, and provides nursing support.</li><li>Collects study data, assists in developing data collection tools, study materials, communication and performs departmental in-services.</li><li>Performs related responsibilities as required.</li><li>Consults with the Research Manager regarding the study implementation process.</li><li>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 Research 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 Institutional Review Board (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 staff resumes and licenses are current. Communicate with Research 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.</li><li>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 Standard Operating Procedures (SOPs), FDA regulations, and International Conference on Harmonization/Good Clinical Practice (ICH/GCP) guidelines. Complete Case Report Forms (CRFs) and study related documents, submit documents to sponsor and/or IRB, if applicable. Ensure sponsor required documents are completed, e.g., screening logs, Adverse event (A/E) forms, memo to file, etc. Plan, organize, and participate in site initiation visits and continued monitoring visits. Review the monitoring reports with the Research Manager. Ensure studies are completed on time and within budget. Communicate with outside vendors such as central laboratories, central IRBs, etc. Provide guidance and troubleshoot issues. Proactively address study concerns and develop timely resolutions. 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, Investigational New Drug (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, Research 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.Communicate with Research Manager regarding resource needs and issues, e.g., supplies, equipment, etc.</li><li>Study Completion. Complete study close out procedures. Submit closeout documents to sponsor and IRB. Compose year end status report for Research Manager and research staff. Return study product, if applicable. Submit yearly post study documents, as required. Ensure study material are stored and maintained for appropriate time line.</li><li>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.</li><li>Assist with maintaining an updated training manual for research.</li><li>Participate in the training of other research staff as assigned.</li><li>Track project milestones and report progress and issues to Research Manager.</li><li>Create and promote positive team morale.</li><li>Discuss role responsibilities, define performance expectations, provide ongoing feedback and conduct regular performance review (verbal and written) as indicated by company policy with research staff members.</li><li>Identify skill deficiencies, and appropriate training work experience to eliminate a skill gap.</li><li>Attend SOP, IRB, GCP, ICH, and FDA training sessions.</li><li>Attend related courses, seminars, and meetings.</li><li>Ensure that skills are continually sharpened and that learning and competency building are focused on routinely.</li><li>Read professional journals and publications to stay abreast of regulations and study management and to learn scientific area.</li><li>Obtain information from the field on relevant new scientific developments that identifies needs for staff training, if applicable.</li><li>Serve as a department resource for general study related issues.</li><li>Create and/or deliver project specific training to ensure adequate training specific to project requirement, e.g., project overview, study protocol information.</li><li>Assist in providing/obtaining training that is role specific, e.g., monitoring GCP, ICH, SOPs and FDA.</li><li>Provide needed assistance as requested to effectively manage projects, schedules and deadlines, vacation schedules, sick-leave, etc.</li><li>Participate in company-required training programs.</li><li>Maintain time and attendance records as directed by Research Manager.</li><li>Follows procedure should a protocol require medications prescriptions (i.e. written or phone-in) in that all requests will be given to the Research Manager for execution of such prescription.Research RN will not phone in prescriptions for subjects.</li><li>Performs other related job duties or functions as requested or assigned.</li></ul> Physical Demands <ul><li>Weight Lifted: Up to 50 lbs, Occasionally 0-30% of time</li><li>Weight Carried: Up to 20 lbs, Occasionally 0-30% of time</li><li>Vision: Moderate, Frequently 31-65%of time</li><li>Kneeling/Stooping/Bending: Occasionally 0-30%</li><li>Standing/Walking: Occasionally 0-30%</li><li>Pushing/Pulling: Occasionally 0-30%</li><li>Intensity of Work: Occasionally 0-30%</li><li>Job Requires: Reading, Writing, Reasoning, Talking, Fingering, Driving </li></ul>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.

Research Nurse Coordinator RN - Oncology - MF 8 hour days

Analysis Skills

Calendar Management

Case Report Form (CRF)

Clinical Research

Consulting

Corporate Policies

Detail Oriented

Establish Priorities

FDA (Food and Drug Administration)

Informed Consent

Medications

Microsoft Outlook

Microsoft PowerPoint

Multitasking

Nursing

Oncology

Patient Education

Patient Follow-up

Performance Reviews

Prescription Drugs

Project Schedule

Project Tracking

Proofreading

Publications

Registered Nurse (RN)

Regulations

Research Nursing

Research Protocols

Schedule Development

Staff Policies

Staff Requirements

Staff Training

Training Program

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