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Clinical Trials Specialist
Req ID: 45026BR
Job Summary: Reporting to the Program Manager (PM) the Clinical Trials Lead-CCTO (CTL) is responsible for overseeing the progress of protocols and planning and prioritizing the work of the Clinical Research Assistants (CRAs) in their assigned disease program(s) within the BIDMC Cancer Clinical Trials Office.
- Partners with the Program Manager and experienced staff to train and coach Clinical Research Staff in their assigned disease program(s). Monitors performance of staff, reports ongoing problems, and provides feedback to PM both routinely and at the time of annual review. Works with staff to resolve day-to-day protocol and patient related problems.
- Ensures the overall conduct of trials progresses as planned and in compliance with local and federal regulations. Runs weekly research team planning meetings, ensuring staff have appropriately completed tasks from prior week and prepared for the forthcoming week. Maintains expert knowledge of trial status for relevant portfolio
- In collaboration with the PM and regulatory staff, assists with activation of new protocols and amendments. Attends Site Initiation Visits and reviews protocol documents to determine operational requirements. Organizes project resources and ensures staff training and documentation for amendments. Ensures timely submission of annual reviews to the IRB.(
- Monitors strict adherence to data management requirements by clinical research staff. Maintains schedules and procedures necessary for timely and complete data collection. Regularly monitors and reports data compliance status to key stakeholders such as the PI, PM, and others
- Assists with preparation of records for audits. Interacts with industry or sponsoring organization representatives during their visits. Reviews audit and monitoring reports for findings that require escalation or may indicate performance issues.
- Ensures coverage of CRA vacations within the disease program; provide coverage intermittently, as needed. Provides coverage to other CTLs in the office as needed for vacations and/or vacancies.
- Assists in the responsibilities for all clinical trial reporting requirements: Serious Adverse Events (SAEs), Deviations, Violations, Other Events, reviewing reports for accuracy and completeness prior to submission.
- With Program Managers and CCTO Director, jointly accountable for CCTO space and equipment checks and sponsor equipment inventory
- Bachelor's degree required.
- Completion of GCP/HSP training within 4 weeks of hire and recertification every three years thereafter.
- 3-5 years related work experience required in Related experience.
- Prior experience in clinical research. Prior experience in cancer clinical trials in an academic medical center setting.
Critical Thinking Skills: The ability to make reasoned judgments that are logical and well-thought out.
- Must be able to read and understand complex scientific documents.
- .Familiarity with electronic medical records and medical terminology.
- 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.
- 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 summarize and communicate in English moderately complex information in varied written formats to internal and external customers.
- Oral Communications:Ability to comprehend and communicate complex verbal information in English to 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.
- Team Work: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 and staff training to meet customer service standards and expectations for the assigned unit(s). Resolves service issues in the assigned unit(s) in a timely and respectful manner.
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
EOE StatementBIDMC is EOE M/F/VET/DISABILITY/GENDER IDENTITY/SEXUAL ORIENTATION
VaccinesAs 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. BILH requires that all staff be vaccinated against influenza (flu) and COVID-19 as a condition of employment.
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