Clinical Research Manager

The Department of Medicine (DOM) leadership seeks to establish transparent and uniform clinical research infrastructure.  Our goals are to enhance efficiency, increase productivity, and ensure proper billing and collection of all research revenue. An administrator with clinical trial, regulatory, and financial experience will be hired to oversee clinical research operations, simplify processes, and provide support and education to investigators and study coordinators in all divisions. The Clinical Research Manager will report to the Vice Chair for Research and the Unified DOM Research Administrator.

Responsibilities of the Clinical Research Manager will include:   

Navigate industry sponsored clinical trial process from initiation to completion

Liaison with Office of Clinical Trials, BRANY, Einstein IRB, Velos, Epic, and Research

Compliance to ensure efficient workflow from department approval, contract negotiation, legal review, IRB approval, establishment of individual fund account for each industry sponsored study, invoicing, collection of all revenue, proper documentation in Velos, etc.

Review feasibility and trial budgets with PIs early in process

Ensure Medicare Coverage Analysis is performed (if needed)

Ensure research billing review is performed (when applicable) in Epic and escalate any workflow or compliance issues as needed. Liaise with Hospital and Professional Billing teams

Liaise with research administrators/managers in other clinical departments – especially as it pertains to DOM clinical revenue delayed by studies in other departments

Ensure each IRB-approved study has a regulatory binder

Partner with departmental finance team to establish monthly expenditure reports for all active trials and to ensure trials and fund accounts are closed when trials are completed or are extended as needed

Ensure all training requirements are being met by all members of the research team

            Human Subjects Protection and Good Clinical Practice (CITI)

            Conflict of Interest

            Comprehensive Velos-Epic Research Training

            Velos Training

            Greenphire ClinCard Training

            Hazardous Goods Shipping Training (IATA)

            Blood Borne Pathogen

Lab Safety Training

Provide education

Ensure study coordinators receive research training when hired and ongoing

            How to document appropriately in Velos and Epic

How to bill appropriately (assign patients to research studies in Epic, indicate standard of care versus research, release bills from the global billing hold, etc.

OCT Lunch and Learn monthly series

                        IRB workshops

                        SOCRA (The Society of Clinical Research Associates)

ACRP (The Association of Clinical Research Professionals

            Educate clinical administrators regarding clinical trial budgets

Ensure study teams are aware of resources available for clinical research (Clinical Research Center, Biomarker and Analytic Core, Biorepository, Data management (REDCap), Greenphire, Biostatistical support, Research and Education Training courses (Clinical Research 101, Design and Conduct of Clinical Research, Clinical Research Training Program, Quality & Performance Improvement Course, etc.)

            Ensure study teams are aware of any updates to research policies/processes that directly impact research operations and overall study workflow

Ensure compliance

            Research Billing –Audit the research billing status of studies within the department of medicine to ensure charges are allocated appropriately; ensure retaining is provided when needed

IRB (submissions, annual progress reports, adverse events, protocol deviations, etc.)

FDA reporting (INDs, IDEs, Annual Reports, Clinical Study Reports, etc.)

Clinicaltrials.gov registration and reporting of results

Use and proper billing for ancillary services and procedures

Pharmacy (investigational drugs, storage and dispensing of drugs, etc.)

Pathology (ordering lab tests, processing and storage of human tissue, etc.)

Radiology (for studies that require imaging)

Bachelor’s degree required; Master’s degree preferred.  Five (5) years of clinical research experience and skills.  Experience in the entire clinical trial process, as well as regulatory expertise is a plus.  Experience at an academic center is preferred.

 Skills & Competencies

• Candidates must be able to deliver results, and exhibit leadership qualities such as accountability, resourcefulness, and integrity.
• This position requires a high degree of flexibility and self-direction since the number, scope, and nature of research protocols are variable.
• S/he must be able to interact well with internal and external stakeholders who may have conflicting priorities and needs.

This position requires a high degree of maturity and the ability to maintain confidentiality of sensitive information, such as compliance issues, medical information, and programmatic issues