Manager Clinical Research

Highmark Health; Pittsburgh (Allegheny County); On-site; USD 85,000 - 125,000; Full time

Job summary

Allegheny Health Network seeks a capable leader to supervise daily clinical research activities, ensuring compliance with internal policies and external regulations. The role coordinates study progress, enrollment, and staff performance within the research department.

The position involves allocating workloads, monitoring regulatory developments, guiding staff training, and overseeing budgets with regular management reporting.

Qualifications

• Bachelor's degree or equivalent experience as determined by company.
• Minimum 5 years of clinical research experience.
• Master's degree preferred.
• Research Coordinator certification preferred.
• Experience with budgets and regulatory oversight helpful.

Responsibilities

• Promotes growth and development of research through networking with internal and external agencies. Acts as a liaison to facilitate study progress, compliance and enrollment.
• Evaluates the workload of personnel and study requirements and appropriately distributes responsibilities to staff. Manages the day to day operation of the clinical research department.
• Regularly reviews the trends and rulings of the governing authorities and monitors and ensures departmental compliance for both internal and external agencies.
• Supports and oversees the orientation, education and evaluation of all departmental research staff members by conducting performance evaluations and maintaining records of employee competencies, mandatory education and required certifications.
• Oversee the financial aspect of clinical research studies, participates and monitors clinical trials budget processes and provides reports to management.

Skills

Clinical research experience

Regulatory compliance

Education

Bachelor's degree or relevant experience

Master's degree

Research Coordinator certification

Tools

SPSS

Excel

Word

PowerPoint

Electronic data capture (EDC)

Job description

Company :

Allegheny Health Network

Job Description :

GENERAL OVERVIEW:

Provides day to day supervision of all activities surrounding the research in the department to ensure compliance with internal and external regulatory agencies.

ESSENTIAL RESPONSIBILITIES:

• Promotes growth and development of research through networking activities with internal and external agencies. Acts as a liaison to facilitate study progress, compliance and enrollment. (30%)
• Evaluates the workload of personnel and study requirements and appropriately distributes responsibilities to staff. Manages the day to day operation of the clinical research department (30%)
• Regularly reviews the trends and rulings of the governing authorities and monitors and ensures departmental compliance for both internal and external agencies. (20%)
• Supports and oversees the orientation, education and evaluation of all departmental research staff members by conducting performance evaluations and maintaining records of employee competencies, mandatory education and required certifications. (10%)
• Oversee the financial aspect of clinical research studies, participates and monitors clinical trials budget processes and provides reports to management. Performs other duties as requested. (10%)

QUALIFICATIONS:

Minimum

• Bachelor's degree or relevant experience and/or education as determined by the company in lieu of bachelor's degree
• 5 years of clinical research experience

Preferred

• Master's degree
• Research Coordinator certification
• Experience in clinical research budgets as well as required computer skills including SPSS, Excel, Word, PowerPoint and electronic data capture reporting

Disclaimer: The job description has been designed to indicate the general nature and essential duties and responsibilities of work performed by employees within this job title. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job.

Compliance Requirement: This job adheres to the ethical and legal standards and behavioural expectations as set forth in the code of business conduct and company policies.

As a component of job responsibilities, employees may have access to covered information, cardholder data, or other confidential customer information that must be protected at all times. In connection with this, all employees must comply with both the Health Insurance Portability Accountability Act of 1996 (HIPAA) as described in the Notice of Privacy Practices and Privacy Policies and Procedures as well as all data security guidelines established within the Company’s Handbook of Privacy Policies and Practices and Information Security Policy.

Furthermore, it is every employee’s responsibility to comply with the company’s Code of Business Conduct. This includes but is not limited to adherence to applicable federal and state laws, rules, and regulations as well as company policies and training requirements.

Highmark Health and its affiliates prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities and prohibit discrimination against all individuals based on any category protected by applicable federal, state, or local law.

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