ACDM SPECIAL PROJECTS COORDINATOR
The Methodist Research Institute - Houston, TX

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JOB SUMMARY

Provides specialized regulatory and GLP support to the Comparative Medicine and Regulatory Affairs/ GLP Department in TMHRI. Responsible for project management as assigned, including leading, coordinating, and completing activities and projects related to GLP and other regulatory affairs projects.

This person will report to the Director of Comparative Medicine.

GROUP SERVED

TMHRI Comparative Medicine Department, MITIE, Principal Investigators and staff doing preclinical research at TMHRI.

DUTIES AND RESPONSIBILITIES

1. Assists with the regulatory management of maintenance of GLP in TMHRI facilities. Oversees compliance with all necessary regulations that apply to TMHRI facilities.

2. Assists with the development of standardized processes and creation of SOPs and training processes for GLP.

3. Assists with the implementation, maintenance and management of regulatory affairs special projects as assigned.

4. Monitors departmental regulatory, GLP files, processes and plans. Identifies and reports quality and service improvement opportunities through analysis of metric data on these processes.

5. Coordinates numerous initiatives which support a professional practice environment including training of Comparative Medicine and MITIE staff and directors in GLP. Works with Manager of regulatory Affairs to establish compliant GLP processes at all appropriate TMHRI facilities

6. Submits required, compliant regulatory affairs submissions to FDA in a timely fashion. Maintains compliant files for such submissions.

7. Conducts Quality Assurance inspections and audits of GLP facilities at TMHRI- works with facility teams to maintain compliance, performing additional training if needed

8. Assures regulatory compliance with federal, state and local laws and policies related to the institution and departmental programs.

9. Interfaces with regulatory (USDA, IACUC, FDA) agencies if required for submission of data, studies or processes.

10. Hosts inspections of GLP facilities if applicable ' works with facility team to respond to reports from inspections and to assure corrective actions are taken

11. Performs supplier and vendor audits if required to maintain GLP compliance

12. Maintains GLP QA records

13. Fosters a 'customer focused' environment.

14. Participates in problem definition and resolution activities.

15. Responsible for knowledge transfer to other staff and may review work of other staff in regards to GLP maintenance in the appropriate facilities.

16. Demonstrates the components of the ICARE values statement.

17. Demonstrates ServicePride Standards.

18. Performs other duties as assigned.

EDUCATION REQUIREMENTS

High school diploma or equivalent GED.

Associate degree preferred.

EXPERIENCE REQUIREMENTS

5+ years experience in GLP research operations, capable of conducting GLP audits.

CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED

Certified by professional and/or scientific organization, such as RQAP in GLP

1. Member of Society of Quality Assurance preferred

SPECIAL KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

1. Strong analytical and interpersonal skills.

2. Ability to work under pressure and balance many competing priorities.

3. Proficient in spreadsheet and word-processing, with some presentation software experience.

4. Demonstrates effective communication skills.

5. Maintains a positive and supportive attitude and demeanor.

6. Professional handling of exposure to confidential/sensitive information.

WORKING ENVIRONMENT

1. The working environment is varied to include general office, with normal amount of lifting, carrying and walking.

2. Demonstrates the ability to use computer technology to review and analyze data, plan and communicate.

3. Must be able to work in Comparative Medicine atmospheres for the purposes of conducting audits, training and process development:

a. Must be able to work in and around animal research facilities, meeting all safety, confidentiality and technical needs.

Provides specialized regulatory and GLP support to the Comparative Medicine and Regulatory Affairs/ GLP Department in TMHRI. Responsible for project management as assigned, including leading, coordinating, and completing activities and projects related to GLP and other regulatory affairs projects.

This person will report to the Director of Comparative Medicine.

GROUP SERVED

TMHRI Comparative Medicine Department, MITIE, Principal Investigators and staff doing preclinical research at TMHRI.

DUTIES AND RESPONSIBILITIES

1. Assists with the regulatory management of maintenance of GLP in TMHRI facilities. Oversees compliance with all necessary regulations that apply to TMHRI facilities.

2. Assists with the development of standardized processes and creation of SOPs and training processes for GLP.

3. Assists with the implementation, maintenance and management of regulatory affairs special projects as assigned.

4. Monitors departmental regulatory, GLP files, processes and plans. Identifies and reports quality and service improvement opportunities through analysis of metric data on these processes.

5. Coordinates numerous initiatives which support a professional practice environment including training of Comparative Medicine and MITIE staff and directors in GLP. Works with Manager of regulatory Affairs to establish compliant GLP processes at all appropriate TMHRI facilities

6. Submits required, compliant regulatory affairs submissions to FDA in a timely fashion. Maintains compliant files for such submissions.

7. Conducts Quality Assurance inspections and audits of GLP facilities at TMHRI- works with facility teams to maintain compliance, performing additional training if needed

8. Assures regulatory compliance with federal, state and local laws and policies related to the institution and departmental programs.

9. Interfaces with regulatory (USDA, IACUC, FDA) agencies if required for submission of data, studies or processes.

10. Hosts inspections of GLP facilities if applicable ' works with facility team to respond to reports from inspections and to assure corrective actions are taken

11. Performs supplier and vendor audits if required to maintain GLP compliance

12. Maintains GLP QA records

13. Fosters a 'customer focused' environment.

14. Participates in problem definition and resolution activities.

15. Responsible for knowledge transfer to other staff and may review work of other staff in regards to GLP maintenance in the appropriate facilities.

16. Demonstrates the components of the ICARE values statement.

17. Demonstrates ServicePride Standards.

18. Performs other duties as assigned.

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High school diploma or equivalent GED.

Associate degree preferred.

EXPERIENCE REQUIREMENTS

5+ years experience in GLP research operations, capable of conducting GLP audits.

CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED

Certified by professional and/or scientific organization, such as RQAP in GLP

1. Member of Society of Quality Assurance preferred

SPECIAL KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

1. Strong analytical and interpersonal skills.

2. Ability to work under pressure and balance many competing priorities.

3. Proficient in spreadsheet and word-processing, with some presentation software experience.

4. Demonstrates effective communication skills.

5. Maintains a positive and supportive attitude and demeanor.

6. Professional handling of exposure to confidential/sensitive information.

WORKING ENVIRONMENT

1. The working environment is varied to include general office, with normal amount of lifting, carrying and walking.

2. Demonstrates the ability to use computer technology to review and analyze data, plan and communicate.

3. Must be able to work in Comparative Medicine atmospheres for the purposes of conducting audits, training and process development:

a. Must be able to work in and around animal research facilities, meeting all safety, confidentiality and technical needs.

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