Tennessee Orthopaedic Alliance
Lead Clinical Research Coordinator
Tennessee Orthopaedic Alliance, Nashville, Tennessee, United States, 37247
Job Type
Full-time
Description
The ideal candidate will have strong interpersonal, written, and verbal communication skills with a history of working collaboratively along with demonstrated critical thinking, strong attention to detail, and problem-solving abilities. Candidates must also possess the ability to handle multiple priorities and be results oriented.
In this role you will manage, and support activities related to various aspects of Orthopedic Research from data entry, regulatory and compliance oversight to patient-facing outreach, follow-up phone calls and appointment scheduling.
Job Description:
Management and oversight on the following tasks
Screening and enrolling patients of eligible subjects according to protocol requirements. Organization, entry, maintenance, and accuracy of clinical research data. Lead the research team to assess feasibility and management of research protocols. Maintain regulatory binders for each assigned protocol and prepare and submit annual renewal requests, amendments, and adverse event reports with clinical input according to IRB and Sponsor requirements. Verify patient eligibility for studies by comparing patient history and clinical assessments with protocol requirements. Ensure timely completion of the scheduling of participant appointments, tests, and follow-up visits at the appropriate time in the study timeline to ensure completion of protocol requirements. Maintain a research binder for each participant and collect, enter, and compile participant data using data management software. Maintain a protocol database and/or online spreadsheet for tracking participant activity, financial management and data analysis as needed. Ensure accuracy and timeliness of data so that information may be used by the PI in treatment planning, presentations, and publication.
Requirements
Ideal Candidate:
Currently pursuing advanced college degree or Master's Degree. Excellent ability to manage time and project deliverables. Experience with academic/grant writing and data analysis. Knowledgeable of Good Clinical Practices, ICH Guidelines, OHRP policies and regulatory guidance. Actively seeks new learning opportunities, seeing continued learning as part of work. Develops and achieves personal and professional goals Required Qualifications:
Bachelor's degree Major in Healthcare, Science, Data/Analytics or related field Required Skills & Qualifications:
Proficiency in the use of software applications, databases, spreadsheets, and word processing. Excellent organizational skills. Strong attention to detail and accuracy, with capacity to deliver quality work product within the required deadline. Ability to manage multiple and competing priorities. High level of interpersonal skill, written and oral communication necessary to effectively interact with colleagues at all operational levels. Self-motivated and comfortable working independently, as a team leader, and as a team member. Proven aptitude with the use of common software such as Microsoft Office applications, AirTable, BaseCamp, Oracle, etc. Willingness to continually self-educate.
Full-time
Description
The ideal candidate will have strong interpersonal, written, and verbal communication skills with a history of working collaboratively along with demonstrated critical thinking, strong attention to detail, and problem-solving abilities. Candidates must also possess the ability to handle multiple priorities and be results oriented.
In this role you will manage, and support activities related to various aspects of Orthopedic Research from data entry, regulatory and compliance oversight to patient-facing outreach, follow-up phone calls and appointment scheduling.
Job Description:
Management and oversight on the following tasks
Screening and enrolling patients of eligible subjects according to protocol requirements. Organization, entry, maintenance, and accuracy of clinical research data. Lead the research team to assess feasibility and management of research protocols. Maintain regulatory binders for each assigned protocol and prepare and submit annual renewal requests, amendments, and adverse event reports with clinical input according to IRB and Sponsor requirements. Verify patient eligibility for studies by comparing patient history and clinical assessments with protocol requirements. Ensure timely completion of the scheduling of participant appointments, tests, and follow-up visits at the appropriate time in the study timeline to ensure completion of protocol requirements. Maintain a research binder for each participant and collect, enter, and compile participant data using data management software. Maintain a protocol database and/or online spreadsheet for tracking participant activity, financial management and data analysis as needed. Ensure accuracy and timeliness of data so that information may be used by the PI in treatment planning, presentations, and publication.
Requirements
Ideal Candidate:
Currently pursuing advanced college degree or Master's Degree. Excellent ability to manage time and project deliverables. Experience with academic/grant writing and data analysis. Knowledgeable of Good Clinical Practices, ICH Guidelines, OHRP policies and regulatory guidance. Actively seeks new learning opportunities, seeing continued learning as part of work. Develops and achieves personal and professional goals Required Qualifications:
Bachelor's degree Major in Healthcare, Science, Data/Analytics or related field Required Skills & Qualifications:
Proficiency in the use of software applications, databases, spreadsheets, and word processing. Excellent organizational skills. Strong attention to detail and accuracy, with capacity to deliver quality work product within the required deadline. Ability to manage multiple and competing priorities. High level of interpersonal skill, written and oral communication necessary to effectively interact with colleagues at all operational levels. Self-motivated and comfortable working independently, as a team leader, and as a team member. Proven aptitude with the use of common software such as Microsoft Office applications, AirTable, BaseCamp, Oracle, etc. Willingness to continually self-educate.