Job Description

Clinical Research Manager

Required upon hire: ACRP or SOCRA certification, or other Clinical Research Certification

Education:

Bachelor's Degree Required

Master's Degree Preferred

Experience:

- 7 years of Clinical research experience REQUIRED

- 5 years in management or supervision of clinical trials REQUIRED.

- 5 years Experience in clinical research finance REQUIRED

- Experience in managing data collection, reporting, outcomes, quality improvement, standards/pathways REQUIRED

- Experience in meeting FDA (GCP, ICH guidelines), as well as other Federal, State and Local regulations surrounding human research REQUIRED.

- Experience with working with Pharmaceutical and FDA agency representatives REQUIRED.

Summary

Under the supervision of the Director, the Manager of Clinical Research is responsible for assuring the strategic vision, directions and operations of the clinical research finance department are implemented and adhered to by all staff. Responsible for oversight of the day to day operations of the clinical research finance team. Responsibilities include compliance with regulations and assure good communication between the various ministries, stakeholders and leadership. Assists in developing, implementing and maintaining policies and procedures. Assists in providing on-going formal and informal training for research staff.

Responsible for overseeing the development of research contracting and budgeting standards. Directs the negotiation of contracts for clinical trials and determination of internal costs and development of internal budget for negotiations of sponsored and investigator initiated clinical trials in compliance with applicable state and federal laws and regulations, especially Medicare and Stark Law. Lead the development and implementation of study builds in the clinical trial management system (CTMS).

Skills Needed:

• Computer literate to include advanced level proficiency in Microsoft Office Programs (Word, Excel, Access and PowerPoint), E-mail and Internet.

• Thorough knowledge and understanding of HIPPA, GCP and ICH regulations, clinical trial monitoring, and regulatory compliance.

• Extensive Knowledge of DHHS, FDA, NCI, NIH, OHRP and other relevant regulations concerning research and compliance.

• Knowledgeable of principles of accounting and contract law affecting clinical trials.

• Ability to successfully budget and negotiate industry contracts for sponsored clinical trials.

• Highly organized and attentive to details, problem solving abilities and ability to work with minimal supervision.

• Highly motivated and able to take initiative.

• Ability to prioritize, organize, plan, and implement as well as handle multiple projects/problems simultaneously within a fast paced environment; able to collect and manage large amount of data and maintain databases; communicates progress, challenges and results effectively.

• Knowledge of operations, including human resource, budget management and work flow planning.

• Ability to plan, chair, document and follow-up on administrative and related meetings.

• Ability to work independently and with minimal supervision.

• Ability to be flexible, multi task and switch priorities as well as work comfortably in a deadline driven environment.

• Communicates well with physicians, patients, sponsors and staff on interpersonal and technical levels, both verbally and in writing; demonstrates high integrity and maintains confidentiality of all information.

• Interacts favorably with people by phone and in person, and work effectively as part of a team.

• Demonstrate communication, leadership, and team building skills; evidence of this should includes dealing well with people, effective problem solving, appropriately confronting issues, motivating others as individuals and as groups, planning, organizing and directing the activities of others.

• Excellent written/verbal communication skills to effectively interact with all levels of management, departments, and users.

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