Clinical Trial Assistant
Inclusively Inclusively Sanford, NC Sanford, NC Full-time Full-time $62,800 - $104,500 a year $62,800 - $104,500 a year 4 days ago 4 days ago 4 days ago Inclusively is partnering with a pharmaceutical and biotechnology corporation to hire a Clinical Trial Assistant.
ABOUT INCLUSIVELY:
Inclusively is a digital tech platform that connects candidates with disabilities, who may benefit from workplace accommodations, to inclusive employers.
This includes all disabilities under the ADA, including mental health conditions (e.
g.
anxiety, depression, PTSD), chronic illnesses (e.
g.
diabetes, Long COVID), and neurodivergence (e.
g.
autism, ADHD).
Applicants with one or more of these conditions are encouraged to apply; Inclusively does not require applicants to disclose their specific disability.
It is your hard work and focus that will help in making the company ready to achieve new milestones and help patients across the globe.
How You Will Achieve It Contribute to completion of project milestones and organize own work to meet project task deadlines.
Maintain Trial Master File (PTMF) in accordance with International Council for Harmonization - Good Clinical Practice (ICH-GCP) and Standard Operating Procedures (SOPs).
Review shared space to ensure others are updating tracking and files as requested by the team.
Update the trial and site information as necessary in Corporate Clinical Trial Registry in a timely manner.
Support and coordinate the Clinical Trial Application to ethics committee and regulatory authority, if applicable, to obtain approval within required timeline.
Provide protocol and Informed Consent Document (ICD) Administrative Support to global Project Managers and Study Managers.
Support and coordinate any activities as requested by PMs/SMs and as assigned within required timelines.
Maintain / develop local tracking spreadsheets for study-related documents, data, activities and prepare site supportive material.
Attend appropriate training programs and project teleconferences as applicable.
Assist team with the preparation of any documents or tracking and updating information.
Identify and implement process improvements for inspection readiness, Trial Master File (PTMF) compliance, Investigator Meeting organization.
Ensure the reconciliation of Trial Master File and the Site Master File on a periodic basis.
Qualifications Must-Have Bachelor's Degree Relevant work experience in a health related discipline, pharmaceutical or medical research Demonstrated ability to introduce new ideas Knowledge on all relevant Standard Operating Procedures Ability to prioritize multiple tasks and develop strategies for completion of all required activities Ability to build collaborative working relationships with colleagues and associates both within and external to the organization Experience of managing clinical trial payments Nice-to-Have Experience in management of clinical trial and/or regulatory documents Knowledge of International Conference on Harmonization Good Clinical Practices and local regulations Knowledge of application used in the clinical trials Other Job Details:
Last Date to Apply for Job:
29 DECEMBER 2023 Eligible for Employee Referral Bonus Work Location Assignment:
Flexible Flexible colleagues are assigned a site within a commutable distance where they work about 2-3 days weekly to connect and innovate with their team face-to-face.
However, they also benefit from being able to work offsite regularly when it makes business sense to do so.
The annual base salary for this position ranges from $62,800.
00 to $104,500.
00.
In addition, this position is eligible for participation in the company's Global Performance Plan with a bonus target of 7.
5% of the base salary.
We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments.
Benefits offered include a 401(k) plan with Matching Contributions and an additional Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.
The company compensation structures and benefit packages are aligned based on the location of hire.
The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Job Type:
Full-time Pay:
$62,800.
00 - $104,500.
00 per year
Benefits:
401(k) Dental insurance Health insurance Paid time off Parental leave Vision insurance Schedule:
Monday to Friday Ability to Relocate:
Sanford, NC 27330:
Relocate before starting work (Required) Work Location:
Hybrid remote in Sanford, NC 27330.
Estimated Salary: $20 to $28 per hour based on qualifications.
ABOUT INCLUSIVELY:
Inclusively is a digital tech platform that connects candidates with disabilities, who may benefit from workplace accommodations, to inclusive employers.
This includes all disabilities under the ADA, including mental health conditions (e.
g.
anxiety, depression, PTSD), chronic illnesses (e.
g.
diabetes, Long COVID), and neurodivergence (e.
g.
autism, ADHD).
Applicants with one or more of these conditions are encouraged to apply; Inclusively does not require applicants to disclose their specific disability.
It is your hard work and focus that will help in making the company ready to achieve new milestones and help patients across the globe.
How You Will Achieve It Contribute to completion of project milestones and organize own work to meet project task deadlines.
Maintain Trial Master File (PTMF) in accordance with International Council for Harmonization - Good Clinical Practice (ICH-GCP) and Standard Operating Procedures (SOPs).
Review shared space to ensure others are updating tracking and files as requested by the team.
Update the trial and site information as necessary in Corporate Clinical Trial Registry in a timely manner.
Support and coordinate the Clinical Trial Application to ethics committee and regulatory authority, if applicable, to obtain approval within required timeline.
Provide protocol and Informed Consent Document (ICD) Administrative Support to global Project Managers and Study Managers.
Support and coordinate any activities as requested by PMs/SMs and as assigned within required timelines.
Maintain / develop local tracking spreadsheets for study-related documents, data, activities and prepare site supportive material.
Attend appropriate training programs and project teleconferences as applicable.
Assist team with the preparation of any documents or tracking and updating information.
Identify and implement process improvements for inspection readiness, Trial Master File (PTMF) compliance, Investigator Meeting organization.
Ensure the reconciliation of Trial Master File and the Site Master File on a periodic basis.
Qualifications Must-Have Bachelor's Degree Relevant work experience in a health related discipline, pharmaceutical or medical research Demonstrated ability to introduce new ideas Knowledge on all relevant Standard Operating Procedures Ability to prioritize multiple tasks and develop strategies for completion of all required activities Ability to build collaborative working relationships with colleagues and associates both within and external to the organization Experience of managing clinical trial payments Nice-to-Have Experience in management of clinical trial and/or regulatory documents Knowledge of International Conference on Harmonization Good Clinical Practices and local regulations Knowledge of application used in the clinical trials Other Job Details:
Last Date to Apply for Job:
29 DECEMBER 2023 Eligible for Employee Referral Bonus Work Location Assignment:
Flexible Flexible colleagues are assigned a site within a commutable distance where they work about 2-3 days weekly to connect and innovate with their team face-to-face.
However, they also benefit from being able to work offsite regularly when it makes business sense to do so.
The annual base salary for this position ranges from $62,800.
00 to $104,500.
00.
In addition, this position is eligible for participation in the company's Global Performance Plan with a bonus target of 7.
5% of the base salary.
We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments.
Benefits offered include a 401(k) plan with Matching Contributions and an additional Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.
The company compensation structures and benefit packages are aligned based on the location of hire.
The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Job Type:
Full-time Pay:
$62,800.
00 - $104,500.
00 per year
Benefits:
401(k) Dental insurance Health insurance Paid time off Parental leave Vision insurance Schedule:
Monday to Friday Ability to Relocate:
Sanford, NC 27330:
Relocate before starting work (Required) Work Location:
Hybrid remote in Sanford, NC 27330.
Estimated Salary: $20 to $28 per hour based on qualifications.
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