Clinical Research Monitor and Auditor

Job Summary

The Markey Cancer Center (MCC) is recruiting a Clinical Research Auditor/Monitor for Multi-Center Investigator Initiated Trials. This position performs routine audits of MCC trials, study teams, & research programs in accordance with applicable MCC SOPs, to assess & assure compliance with applicable protocols, CFR, GCP, sponsor requirements, and MCC SOPs utilizing CTMB guidelines. Data monitoring of MCC IITs in accordance with CM & DMP. Review data accuracy and completeness. Perform post audit exit interviews. Prepare audit reports, identifying recommendations and required actions and follow up. Evaluate responses, escalate and resolve. Provide guidance and training. Assist in developing training and education initiatives of MCC research staff. Utilize Knowledge of FDA Guidance Documents, CFR, GCP, NIH, NCI, ORI, & OMB. Assist in the development of and maintain master files of audit and monitoring activities. Assist in the development of CAPA plans. Coordinate audit and monitoring activities. Participate in development of MCC QA office. Participate and report to MCC committees, QA Manager, & ADCT.

Skills / Knowledge / Abilities

• Microsoft Office Pro
• Research databases
• HIPAA, HSP
• Strong knowledge of CFR, GCP
• Knowledge of oncology clinical trials

Does this position have supervisory responsibilities?

No

Preferred Education/Experience

• Bachelor’s degree
• More than ten years experience
• Clinical Research Program Audits and Data Monitoring
• Oncology Clinical Research

Physical Requirements

• Job related travel
• Lifting, pushing, pulling, standing or walking with heavy objects
• Repetitive motion
• Working in confined spaces
• Exposure to PC screens
• Sitting for long periods of time

Shift

Monday-Friday 8:00 am – 5:00 pm (40 hrs/wk). Occassional work outside these hours Monday-Friday. Job-related travel.

Skills / Knowledge / Abilities

• Microsoft Office Pro
• Research databases
• HIPAA, HSP
• Strong knowledge of CFR, GCP
• Knowledge of oncology clinical trials

Required Education

• Bachelor’s degree

Required Related Experience

• 5 yrs

Required License/Registration/Certification

• Clinical Research Associate (CRA), Clinical Research Coordinator (CRC), Certified in Healthcare Research Compliance (CHRC), Certified Clinical Research Professional (CCRP) or other nationally recognized

Physical Requirements

• Job related travel, lifting, pushing, pulling, standing or walking with heavy objects; repetitive motion & working in confined spaces; exposure to PC screens; sitting for long periods of time.

Shift

Monday-Friday 8:00 am – 5:00 pm (40 hrs/wk). Occassional work outside these hours Monday-Friday. Job-related travel.

Job Summary

The Markey Cancer Center (MCC) is recruiting a Clinical Research Auditor/Monitor for Multi-Center Investigator Initiated Trials. This position performs routine audits of MCC trials, study teams, & research programs in accordance with applicable MCC SOPs, to assess & assure compliance with applicable protocols, CFR, GCP, sponsor requirements, and MCC SOPs utilizing CTMB guidelines. Data monitoring of MCC IITs in accordance with CM & DMP. Review data accuracy and completeness. Perform post audit exit interviews. Prepare audit reports, identifying recommendations and required actions and follow up. Evaluate responses, escalate and resolve. Provide guidance and training. Assist in developing training and education initiatives of MCC research staff. Utilize Knowledge of FDA Guidance Documents, CFR, GCP, NIH, NCI, ORI, & OMB. Assist in the development of and maintain master files of audit and monitoring activities. Assist in the development of CAPA plans. Coordinate audit and monitoring activities. Participate in development of MCC QA office. Participate and report to MCC committees, QA Manager, & ADCT.

Skills / Knowledge / Abilities

• Microsoft Office Pro
• Research databases
• HIPAA, HSP
• Strong knowledge of CFR, GCP
• Knowledge of oncology clinical trials

Does this position have supervisory responsibilities?

No

Preferred Education/Experience

• Bachelor’s degree
• More than ten years experience
• Clinical Research Program Audits and Data Monitoring
• Oncology Clinical Research

Physical Requirements

• Job related travel
• Lifting, pushing, pulling, standing or walking with heavy objects
• Repetitive motion
• Working in confined spaces
• Exposure to PC screens
• Sitting for long periods of time

Shift

Monday-Friday 8:00 am – 5:00 pm (40 hrs/wk). Occassional work outside these hours Monday-Friday. Job-related travel.

Skills / Knowledge / Abilities

• Microsoft Office Pro
• Research databases
• HIPAA, HSP
• Strong knowledge of CFR, GCP
• Knowledge of oncology clinical trials

Required Education

• Bachelor’s degree

Required Related Experience

• 5 yrs

Required License/Registration/Certification

• Clinical Research Associate (CRA), Clinical Research Coordinator (CRC), Certified in Healthcare Research Compliance (CHRC), Certified Clinical Research Professional (CCRP) or other nationally recognized

Physical Requirements

• Job related travel, lifting, pushing, pulling, standing or walking with heavy objects; repetitive motion & working in confined spaces; exposure to PC screens; sitting for long periods of time.

Shift

Monday-Friday 8:00 am – 5:00 pm (40 hrs/wk). Occassional work outside these hours Monday-Friday. Job-related travel.

Job Summary

The Markey Cancer Center (MCC) is recruiting a Clinical Research Auditor/Monitor for Multi-Center Investigator Initiated Trials. This position performs routine audits of MCC trials, study teams, & research programs in accordance with applicable MCC SOPs, to assess & assure compliance with applicable protocols, CFR, GCP, sponsor requirements, and MCC SOPs utilizing CTMB guidelines. Data monitoring of MCC IITs in accordance with CM & DMP. Review data accuracy and completeness. Perform post audit exit interviews. Prepare audit reports, identifying recommendations and required actions and follow up. Evaluate responses, escalate and resolve. Provide guidance and training. Assist in developing training and education initiatives of MCC research staff. Utilize Knowledge of FDA Guidance Documents, CFR, GCP, NIH, NCI, ORI, & OMB. Assist in the development of and maintain master files of audit and monitoring activities. Assist in the development of CAPA plans. Coordinate audit and monitoring activities. Participate in development of MCC QA office. Participate and report to MCC committees, QA Manager, & ADCT.

Skills / Knowledge / Abilities

• Microsoft Office Pro
• Research databases
• HIPAA, HSP
• Strong knowledge of CFR, GCP
• Knowledge of oncology clinical trials

Does this position have supervisory responsibilities?

No

Preferred Education/Experience

• Bachelor’s degree
• More than ten years experience
• Clinical Research Program Audits and Data Monitoring
• Oncology Clinical Research

Physical Requirements

• Job related travel
• Lifting, pushing, pulling, standing or walking with heavy objects
• Repetitive motion
• Working in confined spaces
• Exposure to PC screens
• Sitting for long periods of time

Shift

Monday-Friday 8:00 am – 5:00 pm (40 hrs/wk). Occassional work outside these hours Monday-Friday. Job-related travel.

Skills / Knowledge / Abilities

• Microsoft Office Pro
• Research databases
• HIPAA, HSP
• Strong knowledge of CFR, GCP
• Knowledge of oncology clinical trials

Required Education

• Bachelor’s degree

Required Related Experience

• 5 yrs

Required License/Registration/Certification

• Clinical Research Associate (CRA), Clinical Research Coordinator (CRC), Certified in Healthcare Research Compliance (CHRC), Certified Clinical Research Professional (CCRP) or other nationally recognized

Physical Requirements

• Job related travel, lifting, pushing, pulling, standing or walking with heavy objects; repetitive motion & working in confined spaces; exposure to PC screens; sitting for long periods of time.

Shift

Monday-Friday 8:00 am – 5:00 pm (40 hrs/wk). Occassional work outside these hours Monday-Friday. Job-related travel.

Job Summary

The Markey Cancer Center (MCC) is recruiting a Clinical Research Auditor/Monitor for Multi-Center Investigator Initiated Trials. This position performs routine audits of MCC trials, study teams, & research programs in accordance with applicable MCC SOPs, to assess & assure compliance with applicable protocols, CFR, GCP, sponsor requirements, and MCC SOPs utilizing CTMB guidelines. Data monitoring of MCC IITs in accordance with CM & DMP. Review data accuracy and completeness. Perform post audit exit interviews. Prepare audit reports, identifying recommendations and required actions and follow up. Evaluate responses, escalate and resolve. Provide guidance and training. Assist in developing training and education initiatives of MCC research staff. Utilize Knowledge of FDA Guidance Documents, CFR, GCP, NIH, NCI, ORI, & OMB. Assist in the development of and maintain master files of audit and monitoring activities. Assist in the development of CAPA plans. Coordinate audit and monitoring activities. Participate in development of MCC QA office. Participate and report to MCC committees, QA Manager, & ADCT.

Skills / Knowledge / Abilities

• Microsoft Office Pro
• Research databases
• HIPAA, HSP
• Strong knowledge of