Manage daily operations of Clinical Research Center. Responsible for identifying research opportunities, negotiating budgets with various vendors, completing all regulatory documentation including IRB approval, initiating new studies on site including ensuring training of all medical and support staff. Supervise study coordinators, phlebotomist and medical assistants for several large scale trials.
- Clinical Research Manager at Commonwealth Clinical Studies
- Division Administrator at Brigham & Women's Hospital
- Research Administrator at Brigham & Women's Hospital
- Human Resources Recruiter at Brigham & Women's Hospital
8 years, 2 months at this Job
- Bachelor of Science
Assistant Director (Clinical Research Manager and Administrator)
Translational Research Institute on Pain in Later Life (TRIPLL), Weill Cornell Medicine 2017-current
• Manage and supervise research and support personnel; provide constructive feedback, creative problem-solving, and content guidance.
• Manage Pfizer-funded Randomized Clinical Trial of a primary care-based behavioral intervention in population of older adults with comorbid pain and negative emotions, including cognitively impaired participants. Project includes three multi-principal investigators, two research assistants, one IRB coordinator, two Clinical Psychology externs, and three interventionists.
• Successfully assembled and submitted 450-page competing renewal application for $2.5 million National Institute on Aging P30 grant to provide core funding for the TRIPLL; funding status pending.
• Co-write annual progress reports to the National Institute of Health and industry partners; responsibilities include scientific and programmatic content, budget preparation (prime and sub-award), and adherence to NIH Public Access Compliance Policy.
• Re-designed and implemented TRIPLL pilot study program for junior investigators; manage application review process by Executive Committee and submit pilot study applications (including Study Records) to NIA for annual approval; consult with pilot recipients on adherence to updated NIH Clinical Trials requirements.
• Manage TRIPLL's online public communication and dissemination tools; led major website upgrade and redesign; supervise ongoing website maintenance by TRIPLL staff.
• Plan and produce annual webinar series that reached over 450 attendees from 35 states and 8 countries in 2018; facilitate monthly Work-in-Progress Seminars involving multidisciplinary investigators from Weill Cornell and partnering institutions.
• Coordinate annual evaluation activities with Weill Cornell's Clinical and Translational Science Center Director of Evaluation & Continuous Improvement; key evaluation variables include mentoring effectiveness and bibliometrics.
• Optimize management of purchasing, invoicing, and salary for NIH-funded parent and supplement awards (R13, P30, K24, and T32), a two-year Pfizer clinical trial, and a discretionary fund. Fiscal year 2019 grant management includes budget oversight of $1.4 million in funding from industry and NIH.
• Manage T32 Fellowship in Behavioral Geriatrics, including selection and onboarding of Fellows, ongoing support and problem-solving for Fellows, and coordination of annual trainee forum series focused on professional development and grant writing.
• Selected as Division of Geriatrics representative on Weill Cornell Department of Medicine Results, Rewards, and Recognition Committee.
- Assistant Director (Clinical Research Manager and Administrator) at Translational Research Institute on Pain in Later Life
- Senior Research Assistant (IRB Specialist) at Designated as Division
- Research Assistant at Geriatric Research
- Research Assistant at Clearinghouse for Leadership & Environmental Action in Retirement, Cornell University
1 year, 9 months at this Job
- Master of Public Health - Health Policy and Management
- B.S. in Development Sociology - Development Sociology
- - Public Health and Health Promotion
Ensure completeness and accuracy of patient records as established in guidelines of each project
approved by the National Cancer Institute (NCI).
• Train and teach new clinical coordinators on GCP and institutional research SOPs
• Responsible for site management for over 30 clinical studies ranging from pharmaceutical, PI-initiated and Cooperative group studies
• Review patient medical records for study enrollment and screening
- Clinical Research Manager at NORTH SHORE - LONG ISLAND JEWISH, MONTER CANCER CENTER
- Clinical Research Coordinator at COLUMBIA UNIVERSITY MEDICAL CENTER, DEPARTMENT OF MEDICINE
- Clinical Research Assistant at MEMORIAL SLOAN-KETTERING CANCER CENTER, DEPARTMENT OF
- Clinical Research Coordinator at UNIVERSITY OF PENNSYLVANIA HOSPITAL
2 years at this Job
- Doctor of Medicine - MEDICINE
- baccalaureate Certification
- Bachelor of Arts in Health and Societies - Public Health
• Manages the clinical monitoring process and the administration of clinical trials.
• Supervises CRAs in in-house and on-site monitoring, filing, and clinical trial administration.
• Oversees adherence to SOPs, Good Clinical Practice and FDA regulations.
• Helps with the development and implementation of clinical processes, procedures, and programs.
• Manages research coordination staff in the day-to-day operations.
• Ensures that project/department milestones/goals are met and adhering to approved budgets.
- Clinical Research Manager at Hartford Healthcare System
- Lead Clinical Research Coordinator at Hartford Healthcare System
- Manager II at Hartford Healthcare
- Program Director at The Urban League of Greater Hartford
3 months at this Job
- M.S. in Organizational Management and Leadership - Human Services
- B.A. in Sociology - Sociology
55386 [email protected] 612.412.6005 - I serve as the clinical/scientific expert with primary focus on Respiratory Care product lines interacting with marketing, regulatory, research & development, and legal to ensure clinical activities are aligned with business objectives. - I am an expert within the therapeutic category to develop strong relationships with thought leaders and key investigators to drive the clinical agenda. - I develop clinical plans and protocols through strong cross-organizational collaboration & understanding of business needs. - I design clinical projects to collect outcomes data supporting market adoption, new product approvals, and reimbursement. This includes various forms of research such as review articles, health outcomes data, post-marketing studies, and clinical trials. - I develop clinical project plans including key milestones, budget needs, and resource deployment (i.e. internal sources, clinical research organizations (CRO), and institution on site staff). - I conduct clinical studies with responsibility for the following: Identification of appropriate sites/investigators, qualifying, enrolling and training investigators and investigator's site personnel in study protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements. - I monitor study milestones, preparing study documents and providing updates on study status. - I establish and manage publication plans to ensure high impact dissemination of clinical content. - I travel to key thought leaders, clinical trial sites, and key scientific meetings/trade shows (20-30%).
- Global Clinical Research Manager at Hill-Rom ADVANCED RESPIRATORY CARE, INC
- at ADVANCED RESPIRATORY CARE, INC
- Clinical Project Manager at BECKMAN COULTER
- Clinical Project Manager at ROCHE RESEARCH
7 months at this Job
- Master of Science in Public Health - Public Health
- Master of Science in Clinical Research Administration - Clinical Research Administration
- Bachelor of Science in Biomedical Sciences - Biomedical Sciences
Provide leadership to 10 CRC's, 3 research assistance, RA and CRC on board program, promote patient recruitment and learning new skills. Quality Assurance program.
- Clinical Research Manager at Aventiv Research
- Senior Clinical Research Coordinator at Affinity Clinical Research Institute
- Clinical Research Coordinator at SWIA
- Patient Access Representative at Advocate BroMenn Medical Center
6 months at this Job
- Bachelor of Science in Sociology - Sociology
- - Nursing Clinical
- Certificate in Massage Therapy in Massage
- Associate in Applied Science - Applied Science
Clinical Trial Manager, Consultant
• Contribute to the development and review of clinical study protocol synopsis, protocol and amendments to ensure operational feasibility.
• Contribute to development and review of the Case Report Form (CRF) content and testing of the final CRF.
• Actively participate in clinical contract research organization (CRO) and vendor identification, selection and oversight.
• Oversee study start-up activities including feasibility and site selection.
• Develop study-specific procedures, study plans and documents including Clinical Monitoring Plan, Data Management Plan, Data Validation Plan, Case Report Forms (including testing) and completion guidelines, Data Review & Surveillance Plan and/or other operational and essential documents.
• Review vendor-developed or co-developed documents (e.g., specifications, scope of work, operational manuals, communication plans, retention and recruitment plans, data transfer plans, etc.) as requested to provide operational input (including on-time and high quality).
• Ensure appropriate testing/UAT are performed as required (e.g., eCRF screens, database structure, data loading, etc.).
• Ensure that clinical and data management standards are followed for the study data management
• Ensure proper oversight and communicate to teams on monitoring activities, data flow, and data validation and when applicable, coordinate the centralized review of procedures. Perform patient data validation.
• Ensure study documentation is properly maintained and archived in the Trial Master File (TMF) and relevant systems and databases as required.
• Coordinate and support field-monitoring activities through regular meetings/teleconferences and/or visits to clinical study sites and training of monitoring teams.
• Prepare and lead data review meeting; organize and contribute to medical review meetings.
• Collect, synthesize and report study information. Maintain and provide information for monthly study summary (including enrollment curves and timelines) in a timely manner.
• Participate in the development/follow-up of the study budget and selection and management of vendors. Define needs, tasks and responsibilities of external vendors, review contracts, estimate costs of logistical aspects of the study and ensure tracking of payments for operational aspects of the study in collaboration with the Finance department.
• Develop and oversee Key Risk Indicators and Key Performance Indicators and address and escalate issues and trends, as needed.
• Assist in preparation and oversight of study audits/inspections both internal and external. Ensure preparation and proper responses to audit/inspection reports & consolidation of findings and communicate important observations to VP, Clinical Development.
• Perform periodic Trial Master File quality review.
• Contribute to development and review of department processes and procedures.
• The CTM is accountable for operational oversight of the clinical program conducted within Clinical Development. He/she coordinates with CRO personnel working on the designated program to ensure operational consistency, to identify possible synergies, and to ensure that the team works closely together to meet the program goals on time and with high quality.
• The CTM is the primary responsible person for escalation of program issues/information within Clinical Development and will ensure that the VP, Clinical Development and Project Team is being provided with regular reporting on the program progress. The CTM provides input to help ensure alignment according to risk adjustment and study milestones.
• The CTM will work with external vendors in the planning and execution of Investigator Meetings both domestic and international.
• Travel is required up to 20%, both domestic and international.
- Clinical Research Manager at Osmotica Pharmaceuticals
- Sr. Clinical Manager, Consultant at Novartis Pharmaceuticals, Inc
- Sr. Clinical Research Associate (Home Based) at PRA International, Headquarters
- Sr. Clinical Research Associate, Consultant at Regeneron Pharmaceuticals
3 months at this Job
- BA degree - Business Administration
Managing studies globally rare disease, cancer, neurological disease in home trials
• Managing KPI
• Bid defence meeting
• Manage team and project timelines
• Quality insurance
• Training staff nationally
• Set up/start - close out studies
• Feasibility & protocol reviews
• Working with internal/External Vendors
• Business development
• Reviewing SOP NIHR CLINICAL RESEARCH NETWORK NORTH WEST LONDON INDUSTRY Lead Senior Research NURSE Division 2 Feb 2016 - April 2018 To lead and manage on research performance for Division 2, cardiovascular, diabetes, Endocrine, Stroke and Renal, across a Northwest London NHS trusts.
• Responsible for oversight of the research studies and clinical trials activities
• The delivery time to target for commercial and non-commercial studies.
• The education and development of nurse, clinical trial officer and research administrator.
• Facilitate training GCP, fundamental, PDR team building day.
• Strategic development of Service - Advertising for new staff, app for research, induction training, complied clinical and non-clinical competencies documents
• Study feasibility Imperial Collage London -infection diseases
- Global CLINICAL RESEARCH MANAGER at
- at Research Charge Nurses
- Senior Research nurse at Heart Lung Centre London
- Research Nurse Shift Coordinator at PAREXEL INTERNATIONAL
11 months at this Job
- MSc - Clinical Research
- - effective delivery of research
- Advanced Diploma - Adult Nursing
for private practice of medical and gynecologic oncologists. Provide regulatory and study coordinator oversight of Cooperative Group and Industry partnership clinical trials
• Manage study protocols, informed consent process, research charts (source documents and case report forms)
• Preparation and submission of required regulatory documents to local and central IRB's
• Oversee study start up activities: SQV, SIV, IMV, budget preparation , contract oversight, payments/reconciliation, staff training
• Investigational product accountability (receipt, distribution, reconciliation, disposal)
• Processing and shipping of laboratory specimens; IATA certification
• EDC: Inform/Medidata/RAVE, E-Clinical, SEDES, iMedRIS
• Supervise 2 FTE's
- Clinical Research Manager at Women's Cancer Center of Nevada
- Private Clinical Research Consultant at University of California San Francisco
- Investigator Initiated and Cooperative Group protocols at University of California San Francisco-Hematopoietic Malignancies Program: Protocol Project Manager
- Program Mgr/Research Coordinator at Stanford University-Department of Surgery
5 years, 5 months at this Job
- B.S. degree - Health Science & Safety
Develop and maintain research procedures for the Sarcoma Research Program with the goal of standardization, increased efficiency and compliance with institutional guidelines;
• Provide protocol, budget and contract evaluation to ensure project feasibility;
• Develop and negotiate clinical trial research budgets. Communicate budget guidelines to research staff to maintain overall fiscal and contractual compliance;
• Identify areas of risk within the program and address them through resource diversification and distribution. Provide status reports with recommendations to leadership;
• In charge of complete integration of research into the clinic flow by applying Continuous Process Improvement (CPI) procedures;
• Manage personnel including all aspects of hiring, training, and performance evaluation to meet long term objectives;
• Train nurses and other research staff in all study related procedures; Act as the main contact for assistance with protocol interpretation and implementation;
• Maintain direct contact with external partners as industry sponsors and vendors throughout the life of the project in support of the overall research plan;
- Clinical Research Manager at University of Washington - Medical Oncology Division
- Lead Clinical Research Coordinator at University of Washington - Medical Oncology Division
- Lead Research Technician at University of Washington - Medical Oncology Division
8 years, 2 months at this Job
- - Clinical Research
- - Chemical Separation Techniques Course
- Master of Science - Chemistry