The primary responsibilities of this position include, but are not limited to, the following:
Act as the routine liaison between study site and the project team for study related issues.
Ensure protection of subjects, subjects' rights and the integrity of data through monitoring of adherence to Good Clinical Practice, applicable regulatory requirements, Standard Operating Procedures and protocol compliance
Conduct pre-qualification, initiation, routine monitoring and close-out visits in accordance with the relevant SOPs
Source document review and comparison to CRF data
CRF review/retrieval and data corrections
Maintenance of on-site investigator files
Local laboratory documentation
Maintenance of investigational supplies
Reviews consent process for each subject (Informed Consent Form and source documentation)
Verify patient eligibility
Assess protocol compliance and deviations
Handling of safety and efficacy issues, including, but not limited to:
Conducts and documents onsite visits/contacts, including:
Study completion visits
Site visit report preparation within study specific timeframe
Responsible for all aspects of site management as described in the study plans
Serious adverse event reports
Adverse event trends
Proactively identify and resolve issues and potential site and study issues
Assist with regulatory and study start-up activities including contract and budget negotiations, as required
Ensure clinical data integrity and meet study timelines
Provide ongoing updates and support to project management
Mentor junior members of the team
Prepare and deliver staff training sessions
Clinical Review of individual patient listings
Initial clinical review of comprehensive patient data listings
Initial review of study start-up materials: SOPs, draft CRFs, completion manual, compliance forms, study prompters/calendars
Assist in the day to day running of projects assigned
Assist in the preparation of project specific materials e.g., status reports, newsletters, templates, etc.
Participate in project administration as required e.g., photocopying, binder preparation, start-up pack preparation etc.
Maintain an awareness of the literature on cancer therapy, clinical trial design and conduct, and good clinical practice
Perform other duties as assigned by management
What you need:
At minimum, Bachelor's degree (BSc, BA, or RN equivalent) in biological or science-related field or equivalent experience
At least 2 years’ experience as a Clinical Research Associate with a sound track record in managing clinical trial sites
Experience in monitoring oncology early phase studies
Skills and Competencies to be demonstrated:
Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements
Demonstrable multitasking and execution skills
Good interpersonal skills, including communication, presentation, persuasion, and influence
Good organizational skills, including efficiency, punctuality, and collaboration in a team environment
Knowledgeable in the identification, anticipation, and reporting to appropriate management problems relating to study conduct and effective in developing solutions to those problems
Effective knowledge of the drug development process
Fluent in English - Good communication skills: verbal/written
Proficient knowledge of Outlook, Word, and Excel
Ability to travel domestically up to 70%. Limited international travel may be required.
Valid Driver’s License and Passport preferable
Successfully pass background clearance checks which may be run on a periodic basis due to 3rd party contractual obligation requirements
This job does not offer company sponsorship or relocation assistance.
Theradex is an Equal Opportunity Employer.
4 openings. Telecommuting is allowed.
Additional Salary Information: Generous quarterly incentive plan
Internal Number: 1043
About Theradex Oncology
Theradex Oncology is a full-service CRO, conducting early- and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease.