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Clinical Research Compliance Program Manager

Erlanger Medical Center Chattanooga, TN

Job Description



Job Summary:
The Clinical Research Compliance Program Manager has the primary responsibility with development, implementation and operation of the Clinical Research Compliance Program and ensuring compliance with relevant Federal and State-level regulatory guidelines. In this role, the Clinical Research Compliance Manager will lead and provide expert technical assistance to highly visible, sensitive, and multifaceted projects. He/she will investigate compliance concerns identified, summarize findings, develop recommendations for action plans, and provide oversight for the implementation of corrective action measures to promote and strengthen organizational compliance. The Clinical Research Compliance Program Manager will be responsible for setting strategic direction of projects, developing project plans, and providing high quality project management, analytic support services, and technical expertise to a broad array of issues. This position will interact with all levels of management and employees, external consultants and attorneys. This position will be responsible for all compliance related matters involving clinical research projects being performed on site at any and all Erlanger Health System campuses, including but not limited to its practices and clinics, and will be a liaison between Erlanger Health Systems Corporate Compliance Department and the Erlanger Institute of Clinical Research. While this position will be dedicated full time to working with the Erlanger Institute of Clinical Research, the position will have a direct reporting obligation to the Erlanger Health Systems Corporate Compliance Department for matters related to the Erlanger Health System Clinical Research Compliance Program.


Bachelors Degree, preferably in Business Administration or Health Administration from a four-year accredited college or university or combination of Associates Degree and minimum of 2 years applicable experience
Advanced knowledge of Microsoft Office applications
Proficient knowledge of spreadsheet/graphics, presentation, database, and report writer software
Strong project management skills, along with the ability to take initiative and work independently
Strong knowledge of compliance regulations related to Clinical Research

Certified in Healthcare Research Compliance (CHRC) designation, or be willing to obtain such designation within 12 months of start date
Certified in Healthcare Privacy Compliance (CHPC) designation, or be willing to obtain such designation with 18-24 months of start date

Ability to define problems, collect data, establish facts and draw valid conclusions
Ability to effectively present information and respond to questions from supervisor and others
Ability to use a systematic approach to problem solving and troubleshooting
High energy level, comfortable performing multifaceted projects in conjunction with day-to-day activities
Excellent interpersonal skills, ability to get along with diverse personalities and ability to interface with institutional faculty, administrators, providers, and regulatory agencies
Demonstrates positive attitude, and able to interact well and collaborate with other corporate groups (such as Legal Department and Executive Leadership)
Able to work on several projects and investigations simultaneously
Self-motivated; requires limited supervision
Ability to lead and perform special projects
Proficiency in Microsoft Word, Excel, Access, Visio and PowerPoint
Effective presentation skills
Strong knowledge of the FDA and OHRP regulatory requirements for clinical trials
Strong knowledge and experience with HIPAA Privacy and Security Regulations
Strong knowledge and experience with Medicare and/or Medicaid
Experience with conducting Medicare Coverage Analyses (MCA) for clinical trials invoiced to third party payers
Working knowledge of Federal Anti-Kickback Statue and applicable Safe Harbors
Ability to fully understand a clinical research protocol
Have experience in IRB submissions, preferably with an academic medical center IRB
Thoroughly familiar with Good Clinical Practices and procedures, and practices in a clinical research setting
Experience working with pharmaceutical and FDA agency representatives

A minimum of 3 years in clinical research quality assurance, clinical research compliance, regulatory affairs, or clinical research/study coordination function
Experience in managing data collection, reporting, outcomes, quality improvement, and standards/pathways
Experience with compliance auditing
Excellent research skills and exceptional communication and policy drafting skills

Department Position Summary:
Under nominal direction from the Director of Clinical Research Compliance, this position will provide oversight responsibilities of the Clinical Research Compliance Program by:
Effectively communicating the compliance and ethics standards and procedures for clinical research to all employees/affiliated providers and staff through education and training programs;
Developing, implementing, reviewing, revising and providing advice and interpretation around clinical research compliance related policies;
Planning, organizing and conducting comprehensive investigations of suspected violations of the organizations compliance program as that may be related to clinical research activities;
Daily monitoring new, existing regulations, guidelines and regulatory requirements related to clinical research studies;
Critically analyzing situations, data and information and developing and posing probing questions;
Developing reports for documenting compliance activities related to clinical research;
Conducting and reporting on clinical research compliance investigations and monitoring clinical research activities, to include, but not be limited to, working with the Privacy and Security Office and Technology Management Department to ensure the integrity and security of research study data;
Compiling monthly report summaries of cross-departmental investigations and findings, as needed;
Developing appropriate process flow charts and documentation for internal controls and ensuring the continuous functioning of process flow;
Participating in the planning and structuring of the clinical research compliance review process program; ensuring appropriate program and operations processes are in place, identifying opportunities for process improvements through analyses of patterns, forms, and knowledge of the clinical research compliance program;
Developing monthly and quarterly statistical reports and dashboards for view by the Clinical Research Executive Committee (CREC) and Executive Compliance Committee (ECC);
Developing and implementing EHS new education programs and developing face-to-face training of assigned providers, staff and all other appropriate personnel on compliance responsibilities with applicable laws, regulations, and policies and documentation standards as those may relate to clinical research compliance activities;
Providing feedback on additions to the annual compliance work plan as that may relate to clinical research compliance activities;
Assist Erlanger Institute of Clinical Research Department with vendor relationships, as necessary;
Implementing clinical trial regulatory software to manage and track clinical research projects and regulatory submissions;
Maintaining current knowledge of and oversee compliance with IRB, FDA, OHRP and HIPAA regulations;
Conducting compliance auditing activities associated with clinical research studies that include but are not limited to the review of all research-related activities and documents to assess and evaluate the compliance of those activities to internal policies, standard operating procedures and relevant regulatory requirements;
Conducting quality control auditing to verify that clinical data are generated, collected, handled, analyzed and reported according to protocol, standard operating procedures, Good Clinical Practices, and relevant regulatory requirements;
Developing and implementing a comprehensive clinical research compliance auditing plan;
Performing other duties and special projects, as assigned.

Job Details

Date Posted November 26, 2018
Date Closes February 24, 2019
Requisition 22211
Located In Chattanooga, TN
SOC Category 00-0000.00