- Monitors study facility to assure compliance with GCLP and ICH guidelines. (essential)
- Conducts detailed review of clinical studies in collaboration with pharmaceutical companies and other sponsors. (essential)
- Conducts audits of study facility including equipment, documents and procedures to ensure regulatory compliance. (essential)
- Manages Corrective Action Logs, Deviation Trending Logs, SOPs, GCLP Documents and personnel performance for accurate risk assessment and provides recommendation and oversight on efficiency of research quality. (essential)
- Competent in ICH E6 (GCP/GLP/GCLP), ICH Q9, 21 CFR, GDPR and, HIPAA laws and regulations. (essential)
- Ensures study facility inspection preparedness by collaborative efforts across teams and departments as well ensuring GCP/GCLP staff working in designated areas are adequately trained accord to regulatory and SOP standards. (essential)
- Collaborates with document control team in the development, implementation, and maintenance of SOPs, study protocols and supporting documents. (essential)
- Reviews clinical trial and non-human primate data ensuring integrity, privacy, consistency and compliance for multiple trials at a time. (essential)
- Assists as part of the lab administration in the day-to-day functions and activities of the lab, including but not limited to calendar management, ordering, event planning, and other administrative functions as needed(essential)
- Assists the lab with regulatory filings including, but not limited, to shipping permits and adding personnel to the IACUC animal protocols (essential).
- Increases external and internal lab engagement by managing the lab's social media following institutional guidelines, including the center website by creating content, updating news, publications, lab staff profiles, marketing of activities and events. (essential)
- Other duties as assigned.
- Bachelor's degree in Life Sciences or related field required; Master's degree in Life Sciences or related field preferred.
- Solid understanding of FDA good clinical practice guidelines
- Ability to maintain confidential and sensitive information, set own priorities and work both independently and collaboratively with other research and hospital personnel.
- Must demonstrate a positive, professional, and collaborative attitude with peers, supervisors, and colleagues; must possess organization, time management and critical thinking skills.
- Advanced skills with Microsoft applications, which may include Outlook, Word, Excel, PowerPoint or Access and other web-based applications; may produce complex documents, perform analysis and maintain databases.
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Clinical Trials Monitor - Boston, United States - Beth Israel Lahey Health
Description
When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives.
Job Type:
Regular
Scheduled Hours:
40
Work Shift:
Day (United States of America)
The Clinical Trials Monitor (CTM) monitors and audits the investigator-initiated clinical research studies across all disease groups in the Cancer Clinical Trials Office.
The CTM will also help with audit prep by reviewing records for potential FDA or sponsor audits and may be involved in quality improvement and policy.
The position is primarily remote but may require some on site work.Job Description:
Essential Responsibilities:
Required Qualifications:
Competencies:
Decision Making:
Ability to make decisions that are guided by general instructions and practices requiring some interpretation. May make recommendations for solving problems of moderate complexity and importance.
Problem Solving:
Ability to address problems that are varied, requiring analysis or interpretation of the situation using direct observation, knowledge and skills based on general precedents.
Independence of Action:
Ability to follow precedents and procedures. May set priorities and organize work within general guidelines. Seeks assistance when confronted with difficult and/or unpredictable situations. Work progress is monitored by supervisor/manager.
Written Communications:
Ability to communicate clearly and effectively in written English with internal and external customers.
Oral Communications:
Ability to comprehend and converse in English to communicate effectively with medical center staff, patients, families and external customers.
Knowledge:
Ability to demonstrate full working knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations.
Teamwork:
Ability to act as a team leader for small projects or work groups, creating a collaborative and respectful team environment and improving workflows.
Results may impact the operations of one or more departments.Customer Service:
Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving.
Ability to remain calm in stressful situations.Physical Nature of the Job:
Sedentary work:
Exerting up to 10 pounds of force occasionally in carrying, lifting, pushing, pulling objects. Sitting most of the time, with walking and standing required only occasionally.
FLSA Status:
Exempt
As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities.
Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) and COVID-19 as a condition of employment.
