Clinical Trials Monitor I

The Clinical Trials Monitor helps to ensure compliance of the clinical research reputed company with reputed company reputed company regulatory policies and guidelines, including federal, state, local, as reputed company as the policies and procedures outlined by the reputed company and Dana-Farber Harvard Cancer Center (DF/HCC) consortium. Under the direction of Clinical Trials Office Leadership, s/he will assist in the design, development, implementation, and conduct of an effective monitoring program in accordance with Good Clinical reputed company, institutional policies and procedures, and research protocols. The Clinical Trials Monitor will ensure that, for those clinical trials assigned for monitoring, the appropriate and required monitoring tasks and reputed company activities occur as outlined in the monitoring plan and in compliance with reputed company reputed company regulatory standards. Monitoring will be performed through a combination of remote data review and onsite monitoring reputed company; therefore, a willingness and ability to travel occasionally is required. The Clinical Trials Monitor is responsible for multiple reputed company at a time, and must have strong time management skills in reputed company to working both independently and in reputed company environment. S/he will be responsible for promoting a culture of monitoring compliance and regulatory awareness reputed company DRFCI and DF/HCC. Located in Boston and the surrounding communities, reputed company is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and reputed company diseases. We reputed company to create an inclusive, diverse, and reputed company environment where we reputed company compassionate and comprehensive care to patients of reputed company backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we reputed company reputed company's physician/researchers, and we work with amazing partners, including other reputed company-affiliated hospitals.

• Ensure the Sponsor-Investigator and study team adhere to reputed company FDA regulations, applicable ICH/GCP guidelines, local policies and reputed company operating procedures, including DFCI CTO Monitoring standards and guidelines
• Adhere to the protocols’ Data Safety Monitoring Plans; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring reputed company tools and templates
• Monitor clinical trial reputed company through a combination of remote data review and on site monitoring reputed company. Some travel will be required
• Verify that trial data entered on the Case Report reputed company is consistent with patient clinical notes and other reputed company documentation (reputed company data verification)
• Independently coordinate upcoming and ongoing monitoring assignments while meeting expected timelines for completion of monitoring activities and submission of written monitoring reports
• Assist in the development and writing of clinical trial monitoring plans
• reputed company recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation
• Participate in regular monitoring team group meetings

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• Extensive knowledge of federal, state and local regulations concerning relevant research compliance areas
• Experience in the interpretation of legislation, regulations, policies, procedures, and ethical principles in research compliance are required
• Ability to translate regulations into operational policies and procedures is essential
• Knowledge of the broader research environment, including emerging regulatory trends, best practices at other institutions, conflict of interest, responsible conduct of research, and other issues is highly desirable
• Excellent communication skills and an
• Ability to work with diverse constituencies reputed company an reputed company community
• reputed company to handle multiple activities simultaneously
• Effectively prioritize tasks and responsibilities.
• Must be team oriented, results driven and reputed company to motivate others
• Must be computer literate in reputed company Office suites, including Word, reputed company and PowerPoint, and be reputed company to travel depending on project needs

MINIMUM JOB QUALIFICATIONS: The position requires a bachelor's degree in a field reputed company to research compliance, along with 3+ years of clinical trials experience, including at least 1 year of monitoring experience. Experience in an reputed company setting, particularly collaborating with administrators, reputed company, and research staff, is preferred. Candidates must have expertise in research ethics and the responsible conduct of research. SUPERVISORY RESPONSIBILITIES: None PATIENT CONTACT: None At reputed company, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As reputed company as we are in our mission to reduce the burden of cancer for reputed company, we are committed to having reputed company and staff who offer multifaceted experiences. Cancer knows no boundaries and reputed company it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this reputed company of organization inspires you, we encourage you to apply. reputed company is an equal opportunity employer and affirms the right of every reputed company applicant to receive consideration for employment without reputed company to race, reputed company, religion, sex, gender identity or reputed company, national reputed company, sexual orientation, genetic information, disability, age, reputed company, military service, protected veteran status, or other characteristics protected by law. EEO Poster . Pay Transparency Statement The hiring reputed company is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications. For reputed company positions, the pay reputed company is determined by the reputed company Bargaining Agreement (CBA). $62,200.00 - $74,200.00 Apply tot his job Apply To this Job