What are the responsibilities and job description for the IIT Auditor position at Actalent?
Description:
The Quality Assurance Monitor (QAM) is responsible for the ongoing monitoring of clinical trial data for different studies. Click here to read more about the study. This position will concentrate on data accuracy and completeness, protocol adherence, and regulatory submission and documents management. The QAM interacts directly with the sponsor and the study PI as issues arise. The QAM reports directly to the Data Analysis & Coordinating Center. Clinical Operations Manager. Ongoing review includes off-site and on-site monitoring visits, study participant registration, data submission and protocol compliance, adverse event monitoring, regulatory submissions to the IRB, and regulatory documents monitoring via our e-reg system and Complion system. The QAM works directly with the study PI and statistician to provide data in support of protocol reporting.
Specific Responsibilities:
Protocol initiation – Reviews new protocols, specifically sections relating to registration procedures, records to be kept, eligibility criteria, and adverse event reporting, regulatory requirements, and clinical monitoring. Conducts and/or participates in study initiation visits prior to protocol activation.
Protocol registration - Verifies eligibility of and registers/randomizes participants.
Data review - Reviews case report forms submitted for accuracy, protocol compliance and completeness. If errors exist, generates queries and submits them to the coordinator/data manager associated with the protocol.
Adverse event review - Reviews all adverse events submitted to ensure appropriate reporting requirements have been met. Follows all serious adverse events through resolution.
General reporting – Reports data summaries to the study committees as described by the study governance document.
Monitoring Visits - Organizes and participates in the conduct of external monitoring visits at site locations per sponsor guidelines. Generates monitoring visit reports to be submitted to the sponsor and study chair. This may include travel to Canada.
Manuals – Contributes to writing the manual of procedures as part of a collaborative process.
Perform other duties as assigned by Manager such as documenting staff training, collaborating with team members to generate reports, and attending staff meetings
Skills:
Implementation, quality assurance, Clinical research, Oncology, Cra, Clinical trial, Clinical study, Regulatory, Irb, Cro, Gcp, Crc, data entry, data management
Top Skills Details:
Implementation,quality assurance
Additional Skills & Qualifications:
Minimum Qualifications:
Bachelor’s degree in an allied medical profession or other health sciences field or the equivalent combination of education and experience from which comparable skills can be acquired.
Strong regulatory background as demonstrated by knowledge of the Code of Federal Regulations and Good Clinical Practice guidelines.
2-5 years prior experience coordinating or monitoring therapeutic clinical trials.
Experience with data completion or familiarity with data form completion guidelines.
Experience in staff education and training activities.
Minimum Competencies: (Skills, knowledge, and abilities.)
Computer literate in Microsoft Office, Internet, and database use.
Ability to establish and maintain effective working relationships with physicians, affiliate centers and coworkers.
Preferred Qualifications:
Nursing degree, Master’s (MPH, MS) or other graduate level degree or the equivalent combination of education, training and experience from which comparable skills can be acquired.
3-5 years’ experience in clinical trial development.
Prior experience in a clinical research setting preferred.
Prior experience working with single institutional review boards in multi-site studies
Preferred Competencies: (Skills, knowledge, and abilities)
Knowledge of data management and case report form development with multi-site coordination
Knowledge REDCap database management
Experience with case report forms and protocol document management and version control
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
