Regional Clinical Research Manager
Position Summary:
The Regional Clinical Research Manager is responsible for the coordination and administration of clinical trials at 3-4 clinical research site locations within a designated region under the direction of the VP of Operations and Director of Research Strategy and Operations. They are responsible for overseeing clinical research staff to ensure the successful conduct of clinical trials, and ensuring compliance with established regulations and standards. Job Relationships:
- Reports directly to the Director of Strategy and Operations and indirectly to the Urology America leadership. This role is also responsible to the individual market presidents, the Principal Investigators of each trial, and the physician partners of each practice.
- Collaborates with clinical providers, local vendors, site staff, clinic patient navigators, IT, and data management.
- Must have ≥ 5 yrs experience with conducting clinical trials.
- Urology based clinical experience highly preferred.
- Bachelor’s degree in a health or science field preferred.
- Experience with overseeing and conducting pharmaceutical and device study protocols.
- Must have knowledge of and experience with GCPs and relevant federal and state regulatory guidelines.
- Excellence in computer software including Microsoft Office Suite, EMR, Practice Management, Electronic Data Capture (EDC), and Clinical Trail Management Systems (CTMS).
- Exceptional time management skills and the ability to prioritize work.
- Excellent communication skills and the ability to interact with all levels of management, staff, sponsors, and providers.
- Work to build and manage research departments in scope, size, reputation, and professionalism and works to accomplish this in all locations and markets assigned.
- Leads research department staff by conducting training, assigns delegation of responsibilities, supports staff hiring, and manages yearly staff reviews, etc. Oversight and support of CRCs in all markets is a primary responsibility of this role.
- Assists with patient recruitment for studies, review protocols, completion and submission of feasibility documents, leads trial set-up and launch, plans for and oversees site qualification, initiation, monitoring, audit visits, etc. Supports these endeavors in all locations and markets assigned.
- Maintain relevant certifications in, and continually update knowledge of, FDA, GCP, ICH, federal and state regulations, etc. Provide relevant updates to other research staff as applicable.
- Works closely with the IRB/Recruitment Specialist to ensure timely submissions, updates, close-outs, etc.
- Responsible for maintenance of accurate and complete documentation, primarily executed by the CRCs, including but not limited to regulatory documents, signed informed consent forms, source documentation, drug dispensing logs, subject logs, and study-related communications.
- Design, implement, and manage system for organizing, planning, and controlling workflow related to all clinical research activities.
- Work with the EMR and data management systems to complete/monitor completion of EDC, eCRFs, adverse event documentation, maintain patient records, create strategies for patient recruitment.
- Assist CRCs with identification and prompt reporting of protocol deviations, AEs, and SAEs in accordance with protocol, IRB, and/or sponsor requirements
- Work closely with IRB, study sponsors, PIs and Sub-Is. Attend necessary meetings and calls.
- Provide continuous communication on study conduct, pre-study through post-study to all relevant stakeholders, including internal communication regarding enrollment, progress, and completion of trials.
- Monitor invoicing, billing, and payments, in collaboration with the finance department to ensure timely and accurate A/R process.
- Create, review, and maintain staff CVs, certifications, etc.
- Evaluate, purchase, maintain necessary equipment and equipment monitoring.
- Participate in site visits, SIVs, monitoring, etc.
- Work directly with patients to support CRCs in screening, consenting, history taking, completing necessary exams including EKG, blood draw, vitals, procedure visits, etc.
- Complete necessary study close-out steps and documentation.
- Prepares for and participates in FDA inspections.
- Communicate with and support patients and their families as necessary.
- Maintain HIPAA compliant communication and confidentiality, at all times.
- Assist with other duties assigned.
- Acts as primary liaison to local market clinic and research department.
Knowledge
- Knowledge of clinical research in a specialty setting; medical practice clinical and administrative systems, clinical research software, and sponsor requirements for successful clinical trial completion.
- Understanding of medical terminology.
- Ability to use multi-line phone systems and relevant computer systems.
- Interpersonal and communication both with internal staff and external customers.
- Skill in evaluating and implementing study protocols and budgets.
- Skill in reading medical chart terminology.
- Time Management.
- Ability to communicate effectively with patients, staff, and external contacts via phone, in person, and through electronic mail.
- Elicit appropriate information for patients to clinic staff.
- Ability to read and understand information and ideas presented in writing.
- Ability to apply general rules to specific problems to produce answers that make sense – deductive reasoning.
The physical demands and work environment characteristics described here are the representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions:
- Physical demands : Involves sitting approximately 70-90 percent of the day, walking or standing for the remainder. Work may require stooping and bending, mobility to complete patient study visits, and lifting up to 25 pounds.
- Work environment : Primarily office setting, with time in the clinical setting for patient study visits. Noise level in the work environment is usually moderate. Clean, well-lighted office/clinical environment. Will require travel between Urology Austin clinical locations and outside Ambulatory Surgery Centers (ASC) to meet study demands.
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