Our client is looking for a highly motivated experienced Clinical Trials Research Manager to carry out site based clinical research trials. The candidate must assure site research quality by practicing in compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC, and HIPPA. The position requires the research manager to perform new trial searches, complete feasibilities and conduct start-up activities. Experience with Institutional Review Boards (IRB), Electronic Data Capture (EDC) and Interactive Web Response Systems (IWRS) is expected. Excellent verbal and written skills are required for communication with physicians, staff, patients, monitors, CRO's and sponsors (Pharmaceutical, Biotech and Device manufacturers). Qualified candidates should have managerial, budgeting and contracting experience. The position requires the research professional to be organized, detail oriented, develop and provide accurate source documentation, complete eCRF's, resolve queries and have excellent technical and computer skills. The research manager will work with corporate marketing and sponsor provided central campaigns to develop patient recruitment and retention strategies. The candidate will perform phlebotomy, process and ship specimens, monitor vital signs and perform ECG's. Must be able to execute study visits assuring protocol compliance for dermatology trials for topical, oral, biologic, infusions and device trials.
location: Dallas, Texas
job type: Permanent
salary: $65,000 - 75,000 per year
work hours: 9 to 5
- Ensure department adherence of GCP's, SOP's, IATA, HIPPA and study protocols for multiple clinical trials
- Manage Phase II-IV clinical trials from start through closure
- Work closely with PI, Sub-I and research staff for coordination of trials and procedures.
- Complete feasibility questionnaires and site selection documents
- Manage, train and evaluate research staff
- Ensure research department is meeting contacted and expected recruitment goals
- Report current study status, pipeline trials and site financials
- Manage quality assurance of all study documents and data
- Work with corporate marketing and sponsor provided central campaigns
- Coordinate office visits for trial participants
- Perform phlebotomy, collects, processes and ships clinical specimens
- Conduct patient care visits and procedures according to protocol
- Receive, dispense study medication, maintain drug accountability and temperature logs
- Performs assessment of patients and ECG's
- Organizes annual inspection of equipment
- Data collection, database entry and basic analysis of study data
- Coordinate monitoring visits and ensures all data queries are resolved
- Reports Adverse Events and Serious Adverse Events
- Trains new study coordinators and research assistants
- Participates in Investigator meeting
- Assists in study development, reviewing protocols, designing CRF's, preparing Informed Consent Forms, developing other study related documents
- Prepares new protocol submissions, site applications, amendments, and renewals for IRB
- Maintains regulatory binders, CRF's, subject charting, and source documents
- Report visits and financials in Real Time Clinical Trial Management System (CTMS)
- Candidates must have at a minimum of five (5) years' experience in the clinical research field.
- Conduct all aspects of the trial from pre site selection through completion.
- The candidate will be based in Dallas Texas, however; there may be some travel required to investigator meetings.
- Bilingual (Spanish), RN a plus.
skills: Clinical research
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.