Clinical Research Manager
• Communication with the Principal Investigators on a day to -day basis on progress of clinical trials. §
• Screening and identifying eligible participants. §
• Consenting participants, scheduling clinic visits, data collection, database maintenance. §
• Oversee compliance, communication with the IRB, FDA, sponsors, maintenance of regulatory documentation, conducting internal audits. §
• Generating case report forms, transcription of data, working knowledge of IVRS, redcap. §
• Identification and report of Adverse and serious adverse events to IRB and sponsors. §
• Writing protocols (both clinical and basic science research) , grant proposals for federal (NIH), foundations (LEDUCQ, AHA , PCORI, RICE-ECCLES) and intramural (University Seed grants). Additional expertise in writing standard operating protocols. §
• Negotiation of contracts with pharmaceuticals and day to -day sponsor communications (Siemens, Biotronik, Sanofi -Aventis, Biosense -Webster, Johnson & Johnson, Boehringer - Ingelheim, Lantheus Medical, Astellas, GE Health Care, Covance and Otsuka Pharmaceuticals). §
• Preparation of budgets for research studies (clinical and basic science research). §
• Hiring, training and delegating study coordinators, grant and contract officers, research assistants and volunteers. §
• Assisting with study design, abstract and manuscript preparations including statistical analysis. §
• Oral presentation of studies in multi-center trial investigator meetings.
- Clinical Research Manager at Comprehensive Arrythmia Research and Management Center
- Adjunct Instructor, Department of Biology at Salt Lake Community College
- Post-Doctoral Research Associate at Rutgers University
- Graduate Teaching / Research Assistant at Illinois State University
8 years, 9 months at this Job
- PHD - Biology
- Master of Sciences - Ecology
- Bachelor of Science - Zoology
Practice Manager- Responsible for developing business strategies, formulating budgets, and handling daily operations including; managing administrative and clinical staff, financial management, billing and collections, and maintenance of buildings. Clinical Research Manager- Manages the clinical research department and oversees clinical research studies. Provide direction to clinical research associates on the development, management, and completion of clinical research studies. Responsible for quality assurance, compliance with regulations, proper documentation, and budgeting for the department.
- Practice Manager/ Clinical Research Manager at Allergy Partners
- Practice Manager III at Maternal-Fetal Specialists at Greenville Health System
- Office Manager at National Allergy and Asthma Centers of Charleston
3 years, 2 months at this Job
- Masters in Business Administration - Healthcare Management
- Bachelor of Science - Physical Education
currently on consultant basis) ◦ Ensure compliance with good clinical practices, federal regulations and institutional IRB policies. ◦ Department payroll and human resources representative: hiring practices, employee relations, time and attendance reporting, and employee evaluations. Work in conjunction with financial manager on budget, faculty recruitment and hiring. ◦ Department liaison between Division Chairmen and clinic staff. Work with study sponsors and Principal Investigators on feasibility of clinical trials i.e. budget and personnel constraints. Monitor enrollment goals and modify recruitment as necessary. ◦ Write and maintain Standard Operating Procedures (SOPs) develop and maintain informational database regarding study protocol and study subject data. Work with study monitors on audits, site visits etc. Attend investigator meetings. ◦ Supervise all clinical coordinators and research staff. Manage and direct clinic activities. ◦ Member of Executive Steering Committee in which division chair, faculty and management initiate planning strategies and budgets. Work Related Memberships and Certificates: American College of Healthcare Executives, Society of Clinical Research Professionals (SOCRA), Management Development Certificate, RATS Training Series, CPR Health Care Provider certified. Clinical Nutrition Certificate WCM-Q.
- Clinical Research Manager at University of Utah Department of Cardiovascular Genetics Research
- Assistant Director at Weill Cornell Medicine
24 years at this Job
- Masters of Business Administration - Healthcare Administration and Management
- Certificate - Russian
- Bachelor's - Government and International Affairs
• Provided GCP and project training to site staff.
• Assisted in the development of associated study documents (Safety Monitoring Plans, Manual of Operations and Informed Consents).
• Identified site issues/problems, and associated root causes, and developed action plans to ensure resolution.
• Provided the main line of communication between the sites and management.
• Led study start up team as needed.
• Managed study sites to ensure site compliance with study protocols, GGP/ICH, and applicable regulations.
• Conducted monitoring visits (Qualification, Site Initiation, Interim, Close-out, Audit Prep).
• Generated clinical monitoring reports and follow up letters in a timely manner.
• Verified that all research staff and facilities had adequate qualifications and resources and maintained this throughout the course of the clinical study.
• Ensured adverse events, concomitant medications, and inter-current illnesses were reported in accordance with the protocol on the CRF.
• Communicated deviations from the protocol, SOPs, GCP, and applicable regulatory requirements to the investigator and ensured corrective actions were implemented.
• Utilized CTMS to generate, review and provide study reports.
• Assisted with setup, quality and maintenance of the Trial Master Files (TMF) in accordance with ClinicalRM SOPs, Good Clinical Practice (GCP), ICH guidelines and federal regulations.
• Participated in project team meetings.
• Assisted the Project Management team in preparation for audits or inspections.
• Assisted with protocol development and review as needed.
• Worked closely and effectively with all other department personnel to ensure appropriate communication and study conduct.
• Functioned as a mentor for team members.
• Maintained awareness of current developments in therapeutic area relative to assigned projects.
• Throughout the conduct of the clinical trial assessed adherence to SCRI SOPS, GCP and all applicable regulatory requirements.
• Traveled as necessary.
- Clinical Research Manager at ICON/Clinical RM
- Senior Clinical Research Associate at Inventiv Health
- Clinical Research Coordinator at HOLY CROSS HOSPITAL
- Sales Manager, Florida at HEALTHCARE UNDERWRITERS GROUP
8 months at this Job
- MS in Human Services Administration - Human Services Administration
- BS degree in Nursing - LANGUAGES
SKILLS Luke's Clinics - Rheumatology, Orthopaedics, Neurology, Wound Care and
• Adaptability in a variety Travel Medicine of work environments Boise, ID - 2003 - Present Oversee work of Clinical Research staff ensuring timely and accurate completion of duties.
• Critical thinking and Work in a dyad relationship with the Medical Director to serve as a clinical resource related decision making to the ethical conduct of human subjects research. Recruit and manage study pipeline to maintain constant flow of new studies. Develop and manage business unit budget inclusive
• Attention to detail and of review and monthly reporting of revenue, expenses and productivity of employees. accuracy Provide leadership in the development, implementation, and maintenance of clinical research training, education and orientation program.
- Clinical Research Manager at St. Luke's Intermountain Research Center
16 years at this Job
- Bachelor of Science in Biology - Biology
Clinical Research Manager: with experience in training, interviewing, developing standard operating procedures, quality assurance and negotiating budget and contracts. Responsible for utilizing Electronic Medical Record to maintain patient records with accurate documentation, while still providing quality care to patients in Women’s Health Research. Organize and conduct monthly meetings with research staff, doctors and the director of research, and maintain emergency kit containing Epi pens, Benadryl, oxygen, AED and procedures of implementing the emergency plan for patients during a life threatening event. Manage and supervise a nursing staff of 4. employees. Responsible for approving scheduled leave, reviewing timecards, and performing annual reviews for each of my employees. Serve as the liaison between the research department, clinical staff and HR department. Oversee all aspects of the research department, including but not limited to one on one meetings with the Director of Research, delegation of duties, and ensuring that all duties are completed and correctly performed per standard of care and following good clinical practice/ ICH guidelines. Implement and facilitate improvement plans and additional training when needed.
- Clinical Research Manager at Virginia Women's Center
- Lead Certified Clinical Research Coordinator at National Clinical Research
- Lead Quality Assurance Committee at National Clinical Research
- Certified Clinical Research Coordinator at National Clinical Research
3 years at this Job
Directly manages the training, development and performance of the Thoracic Oncology Medicine research team comprised of 29 team members whose duties include, but are not limited to, data, regulatory, outpatient clinic and patient management of the Thoracic Oncology service's 87 active clinical trial.
• Works directly with internal stakeholders, external stakeholders, a Protocol Activation Manager and the Thoracic Principal Investigators (PI) to complete new clinical trial submissions within 75-90 days. This includes, but is not limited to, budget development, clinical trial agreement approvals, informed consent form approvals, overseeing of protocol operations in preparation for site activation. Ensures service upkeep of Regulatory documents such as federally regulated documentation, investigator credentials, and clinical trial approval documentation from the Institutional Review Board/Privacy Board.
• Works closely with internal and external stakeholders to forecast trial resource needs and assess staffing resources for the Thoracic Oncology program and senior leadership to ensure appropriate line function allocations. Works directly with the Research Program Manager to effectively.
• Generates protocol portfolio status reports for key partners. Implements solutions for streamlining and accelerating the monitoring and review of clinical trials to significantly increase accrual to clinical trials, data cleaning, data quality, and trial completion. Participates and ensures preparedness in routine audits for data quality, regulatory compliance, patient safety issues related to clinical trial. Communicates and ensure compliance with company policies and procedures, quality standards and improvement initiatives.
- Clinical Research Manager at Memorial Sloan-Kettering Cancer Center
- Research Project Manager at Memorial Sloan-Kettering Cancer Center
- Senior Clinical Research Supervisor at Memorial Sloan-Kettering Cancer Center
- Research Study Assistant II at Memorial Sloan-Kettering Cancer Center
1 year, 6 months at this Job
- Bachelor of Arts in Psychology - Clinical Psychology
• Accomplishments: ◦ Secured 6 New Global Research Trials with Companies including Allergan, Alkermes, Edgemont and Otsuka ◦ Tasked with growing enrollment and evaluating patients for new studies went from 3 subjects per day to an average of 15 per day. ◦ Managing 20+ currently enrolled subjects in ongoing studies per week. ◦ Responsible for collecting individualized Informed consent data for each of the seven ongoing trails. ◦ Gather all data necessary for each study including medical history, medical test and laboratory test. ◦ Responsible for all handling of Investigational related drugs with the proper documentation necessary to ensure FDA regulations are met. ◦ Ongoing reporting to Clinical research Associates for each study to ensure protocol conformity and data integrity. ◦ Document and register to individual IRB's all study related forms, consents, visits and conclusions.
- Clinical Research Manager at Research Centers of America
- Case Manager, Group Facilitator at The Florida House Experience
- Sr. Court Transfer Evaluator at Henderson Behavioral Health Center
- Senior Adult Case Manager at South Florida
4 years, 4 months at this Job
- B.A. - Arts
I oversaw the daily operation of a research facility which serviced an Internal Medicine practice. I developed, implemented and coordinated research and administrative procedures for the successful management of clinical trials. I performed diverse administrative duties requiring analysis, sound judgement and a high level of knowledge of study specific protocols. I was responsible for ensuring trials were conducted in an ethical manner always following Good Clinical Practice.
- Clinical Research Manager at Rowan Research, Inc
- Clinical Research Coordinator at Rowan Research, Inc
- Sales and Plant at Blue Moon Garden & Nursery
- Clinical Research Coordinator at Osteoporosis Research Unit
2 years, 8 months at this Job
- Bachelor's Degree
Lead a team of seven to coordinate multiple clinical trials simultaneously for abilities between site staff, subjects and doctors. ophthalmic medications and devices.
• Oversee regulatory activity, including IRB submissions and approvals and take the lead during FDA audits. In a period of 15 months, I met or exceeded recruitment goals in seven different studies; some by as much as 75%. In one trial, I screened 63 patients, 40% more patients than the second place site, and six times the average screening number across 40 sites. From 2016-2018, my efforts produced 44% of the eight person department’s entire annual fiscal goal. I helped institute innovative new systems for the department including streamlined petty cash accounting, supplies management, and coordinator organization.
- Clinical Research Manager at Clayton Eye Clinical Research, LLC
- Clinical Research Manager at Clayton Eye Clinical Research, LLC
- Advanced Science Tutor at The Learning Coach, LLC
- Research Coordinator (Intern) at Emory Center For Ethics
2 years at this Job
- Bachelor's - Biology