Clinical Trials Specialist II

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 is responsible for fostering and enhancing inter-team and inter-group collaboration, serving as a source of knowledge and expertise that can be used as a resource by more junior staff. Instructs others on proper good clinical practices and ensures adequate training is provided for junior staff, managing multiple projects and disease groups, providing guidance on the recruiting and hiring of study team and office personnel, ensuring compliance with federal, state and institutional guidelines and for assessing resources (staff, space, study demands) to assure study team compliance. Financial responsibilities include preparing budgets, advising others on study budget questions and assuring study expenses are appropriately included for all protocols. Supervisory duties include overseeing the progress of protocols and supervising, planning and prioritizing the work of the Clinical Research Staff, as well as collecting performance metrics and providing feedback on employee performance.

Job Description:

Primary Responsibilities:

• Engages with senior management to recruit new hires. Develops training materials, curriculum, trains clinical research staff within the disease groups to ensure compliance with local and federal regulatory requirements. Supervises and monitors performance of staff including new employee education, orientation and continuing education. (essential)

• Uses management skills to ensure disease groups have appropriate internal organization to effectively comply with regulatory requirements for clinical trials. Serves to provide personnel evaluations, recommends various personnel actions including, but not limited to, hiring, performance management, disciplinary action, promotion and transfers. (essential)

• Collaborates with physicians, nurses, Clinical Research Coordinators (CRC) and Clinical Research Assistant I's and II's 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 the most efficient and effective use of personnel and resources. (essential)

• Ensures all staff uniformly complete required orientation and continuing education programs and training, new coordinator training, institutionally mandated training and certification programs, and ensures updated training records are maintained in centralized databases. (essential)

• Provides guidance to other staff to ensure uniform and strict adherence to protocols by physicians, nurses, and patients. Reads and reviews protocol requirements with physicians, nurses, and fellows. Identifies and resolves problems with protocol compliance. Engages physician-investigator and research nurse to address any problems with timeliness and care. (essential)

• Coordinates research activities conducted with affiliates and, along with other senior staff serves as a liaison to other cooperative groups and institutions. (essential)

• Presents periodically at staff meetings to ensure staff is kept abreast of institutional goals, initiatives, policies and procedures. (essential)

• Serves as a resource to Research Administrative staff, physicians, nurses, and non-nursing clinical research staff to identify and provide information needed for special reports, grant applications and other decisions. (essential)

• Provides input on the feasibility of conducting new trials, any personnel conflicts with ongoing trials, and other logistical and administrative issues. (essential)

• Has the authority to direct and support employees daily work activities. Has authority to undertake or recommend the following employment actions: hiring, termination, corrective action and performance reviews. Direct Reports: 2-3 Indirect Reports: None

• Assists in planning, monitoring and/or managing budget in functional area of department.

Required Qualifications:

1. Bachelor's degree in Life Sciences required.

2. 5-8 years related work experience required including 1-3 years supervisory/management experience required.

3. Knowledge of Medical terminology.

4. Personnel Management experience.

5. 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.

Competencies:

Decision Making: Ability to make decisions with significant, broad implicati