Clinical Trials Specialist II

About the Role

When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives. The Clinical Trials Specialist II fosters and enhances inter-team and inter-group collaboration, serving as a source of knowledge and expertise for junior staff. This role manages multiple projects and disease groups, ensures compliance with federal, state, and institutional guidelines, and assesses resources to assure study team compliance. Financial responsibilities include preparing budgets, advising on study budget questions, and ensuring study expenses are appropriately included for all protocols. Supervisory duties involve overseeing protocol progress, supervising and prioritizing the work of clinical research staff, collecting performance metrics, and providing feedback on employee performance.

Responsibilities

• Engages with senior management to recruit new hires.
• Develops training materials and curriculum, and trains clinical research staff within disease groups to ensure compliance with local and federal regulatory requirements.
• Supervises and monitors staff performance, including new employee education, orientation, and continuing education. (essential)
• Ensures disease groups have appropriate internal organization to comply with regulatory requirements for clinical trials.
• Provides personnel evaluations and recommends actions including hiring, performance management, disciplinary action, promotion, and transfers. (essential)
• Collaborates with physicians, nurses, Clinical Research Coordinators (CRC), and Clinical Research Assistants to follow standardized practices for information collection and reporting needed to comply with institutional, state, federal, and international regulatory requirements. (essential)
• Coordinates workflow and assignments of personnel across multiple departments to ensure efficient and effective use of resources. (essential)
• Ensures all staff complete required orientation, continuing education, new coordinator training, institutionally mandated training, and certification programs, and maintains updated training records in centralized databases. (essential)
• Provides guidance to ensure strict adherence to protocols by physicians, nurses, and patients; reviews protocol requirements and resolves compliance problems. (essential)
• Coordinates research activities with affiliates and serves as a liaison to other cooperative groups and institutions. (essential)
• Presents at staff meetings to keep staff informed of institutional goals, initiatives, policies, and procedures. (essential)
• Serves as a resource to research administrative staff, physicians, nurses, and non-nursing clinical research staff for special reports, grant applications, and other decisions. (essential)
• Provides input on the feasibility of conducting new trials, personnel conflicts, and other logistical or administrative issues. (essential)
• Directs and supports employees' daily work activities and has authority to undertake or recommend employment actions such as hiring, termination, corrective action, and performance reviews.
• Assists in planning, monitoring, and/or managing the budget in the functional area of the department.

Requirements

• Bachelor's degree in Life Sciences required.
• 5-8 years of related work experience, including 1-3 years of supervisory/management experience.
• Knowledge of medical terminology.
• Personnel management experience.
• Advanced skills with Microsoft applications (Outlook, Word, Excel, PowerPoint, Access) and other web-based applications; ability to produce complex documents, perform analysis, and maintain databases.

Competencies

• Decision Making: Ability to make decisions with significant, broad implications for the management and operations of a major department or multiple departments.
• Problem Solving: Ability to address broad, complex, and abstract problems, often involving Medical Center-wide issues, using creativity, resourcefulness, staff engagement, Lean diagnostic techniques, negotiation, and diplomacy.
• Independence of Action: Ability to set goals and priorities for functional area with broad guidance and overall direction from management.
• Written Communications: Ability to communicate complex information effectively in writing to all levels of staff, management, and external customers.
• Oral Communications: Ability to verbally communicate complex concepts, address sensitive situations, resolve conflicts, negotiate, motivate, and persuade others.
• Knowledge: Broad and comprehensive knowledge of theories, concepts, practices, and policies with the ability to use them in complex and/or unprecedented situations across multiple functional areas.
• Teamwork: Ability to lead collaborative teams for larger projects or groups, both internal and external to the Medical Center, across functional areas.
• Customer Service: Ability to lead operational initiatives to meet or exceed customer service standards and expectations in a timely and respectful manner.

Work Environment

• Sensory Requirements: Close work (paperwork, visual examination), color vision/perception, visual clarity <3 feet, ability to distinguish hot/cold and sharp/dull, conversation, monitoring equipment, telephone use, and tolerance for background noise.
• Physical Requirements: Sedentary work involving exerting up to 10 pounds of force occasionally; sitting most of the time with occasional walking and standing. Constant sitting and keyboard use; occasional fine manipulation using one hand.
• Environmental Conditions: Potential exposure to adverse conditions, including protective equipment use (respirator, earplugs, mask, eyewear), infectious diseases, airborne pathogens, and bloodborne pathogens.
• Health Care Worker Status: HCW 2: Regular, day-to-day face-to-face contact (e.g., front desk receptionist, interpreters, transporters).

Pay

Annual base salary range: $70,000.00 USD - $99,000.00 USD. Actual compensation is determined based on factors such as seniority, education, training, relevant experience, certifications, geography, job responsibilities, and other applicable factors permissible by law.

Additional Information

As a health care organization, Beth Israel Lahey Health requires all staff to be vaccinated against influenza (flu) as a condition of employment.