Senior Manager, Clinical Research, Pulmonology
Job description
JOB SUMMARY
Manages the development, coordination and implementation of clinical site management for clinical trials (including pharmaceutical and NIH trials). Responsible for assigned projects including trial specific processes and systems, and the daily supervision of the clinical operations team. Works within the matrix of the clinical research system to complete all regulatory applications.
EDUCATION/EXPERIENCE
Master's degree in Education, Public Health, Basic Science or a relevant clinical discipline with five years of survey research experience including two years of supervisory experience. Prefer clinical research experience in therapeutic area.
LICENSURE, CERTIFICATION, and/or REGISTRATION
Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professional (ACRP) certification required.
SKILLS/QUALIFICATIONS
- Ability to analyze financial information
- Knowledge of computerized data processing
- Proficiency in Microsoft Office applications
- Ability to prioritize and organize a high volume workload and changing priorities
- Familiar with principles of protocol development, study design, statistics, and IRB process
- Ability to direct the work of others
- Ability to maintain patient confidentiality and comply with HIPAA regulations
ESSENTIAL FUNCTIONS
- Manages and serves as an expert resource to coordinators in large scale and or multiple protocol clinical research studies conducted by the principal investigator(s) at Atrium Health Wake Forest Baptist/WFU School of Medicine.
- Works with sponsors to develop an adequate budget for clinical trials, ensuring that the site is being compensated correctly for all clinical related procedures. Once budget has been negotiated, works within the Wake Forest University system to facilitate the submission of budget and contract to the appropriate departments.
- Oversees coordinators comply with protocol guidelines and requirements of regulatory agencies; identifies problems and/or inconsistencies and implements corrective actions as appropriate.
- Prepares and submits the study to the Institutional Review Board at Wake Forest University. Works with both the sponsor and the IRB to address all concerns and get the study operational in a timely manner.
- Reviews budgets monthly to determine that sponsor has provided payment for the work that our site has conducted. Checks the budget to ensure the income and debits are correct. Addresses any issues that are not financially accurate.
- Prepares reviews of incoming studies with man hours required, availability of patient population, staffing issues and financial compensation from the sponsor. This information will be presented to the Principal investigator to determine if our site should accept a clinical research study or NIH project.
- Oversees that adequate supplies for projects are available and addresses any issue or shortages.
- Establishes and maintains separate billing files on specific accounts related to individual departments/sections during the course of the project.
- Provides guidance to lower level personnel and assists in training new personnel.
- Reviews journals, abstracts and scientific literature to keep abreast of new developments in assigned therapeutic area.
- Performs other duties as assigned by management.
WORK ENVIRONMENT
- An indoor, clinical research setting
- Possible exposure to infectious and contagious disease
- Possible exposure to body fluids
- Possible exposure to radiation hazards
- May have contact with study patients under wide variety of circumstances
- Laboratory processing procedures
- Required personal protective equipment use as needed
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