Clinical Research Manager Resume
Summary : Complete appropriate role-specific training to perform job duties
Under supervision, perform assigned administrative tasks to support team members with project execution (examples of such tasks include but not limited to running system reports.
Skills : Marketing, Medical Billing And Coding, Medical Terminology, Medical Devices.
- Managed clinical research staff including training, scheduling, coordinating and delegating work.
- Monitored and evaluated performance to promote maximum effectiveness and functional productivity.
- Developed and managed the research program and execution of the studies in consultation with upper management and/or the principal investigator to meet changing needs and requirements of the sponsor and studies.
- Managed clinical research operations which include budget, control and safety compliance, developing policies and procedures and ordering supplies.
- Collaborated with information systems staff and consulting with computer programmer(s) for assessment and data abstraction, queries and process with our current study databases.
- Conducted Clinical Trials from Phase II - IV in the area Pulmonology and Internal Medicine Hosted monitoring visits and reviews of QA source documents while establishing a positive rapport with employees at clinical trial site.
- Responsible for Investigational Product accountability, which included receiving, dispensation and reconciliation for studies that were delegated to me.
Associate Degree In Respiratory Care In Human Biology, Genetics, Respiratory.
Jr. Clinical Research Manager Resume
Objective : Manage all clinical and laboratory aspects of the study and ensure collection, recording and reporting of clean and quality data by performing quality control activities.
Skills : R&D For COnsumer Products.
- Established clinical strategy for two diverse research programs, consisting of five projects.
- Coordinated and aligned cross functional groups to progress clinical project plans.
- Managed eight clinical scientists.
- Builted strong relationship with Dermatology Foundation through sponsoring Annual Symposium for Foundation Award.
- Worked with overseas development counterparts to establish novel protocols and assessments to evaluate technologies to alleviate skin condition prevalent in Southeast Asia.
- Resulted in patent disclosure for novel approach to alleviate Prickly Heat.
- Realigned program resource in 2 projects; refocused team to define clear direction, delineate new priorities, and apply scientific rigor to future efforts.
MS In Zoology
Sr. Clinical Research Manager Resume
Headline : Develops and manages Data Handling Plan (DHP) and Data Review Plan (DRP) for assigned trials, Develops training materials and /or tools for conduct of the study
Skills : Bilingual Spanish, Research, Management, Customer Service.
- Initiated set-up of human laboratory at the Clinical Neurobehavioral Center Set- up different accounts with vendors, LabCorp, equipment servicing and other miscellaneous accounts.
- Developed or assisted with development of study design, protocols, case report forms and other study-specific documents essential to appropriate implementation of clinical investigations.
- Worked with investigators to ensure optimal compliance and performance to the protocol, regulatory requirements, discrepancy reporting and ethical practice.
- Assisted with preparation and execution of Investigator meetings.
- Ensured International Conference on Harmonization, and Good Clinical Practice procedures are followed in all study aspects.
- Participated in vendor selection, and establish plans for data processing and data review with vendors.
- Monitored clinical trials through all phases.
Doctor Of Dental Medicine In Dental Medicine
Clinical Research Manager I Resume
Summary : Under supervision, responsible for assisting in the completion of data management activities according to sponsor and contract requirements and in accordance with applicable standard operating procedures.
Skills : Type 85 words per minute, EMR Solutions, Microsoft Office, Oracle.
- Provided regulatory and clinical coordination for clinical trial: RAMPART (Rapid Anticonvulsant Medication Prior to Arrival Trial).
- Developed and Manage the Richmond Ambulance Authority Research Fellowship Program.
- Enrolled and successfully completed the program and have presented their research at the Virginia State University Annual Undergraduate Research Conference.
- Created company policies to aid in collaboration with internal and external sources when planning and conducting EMS research.
- Co-authored and publish paper related to engaging in EMS research.
- Co-authored of "New Roles for Community Partners in Research: Developing Temporary Satellite Advocates for Research (TSARS).
- Collaborated with VCU's "Community Partnership for Ethical Research" (CPERs) committee.
Master Of Science In Psychology
Clinical Research Manager II Resume
Summary : Proactively identifies opportunities for process improvements. Lead the process improvement opportunities and manage the implementation of associated revised processes and procedures.
Skills : EMR, Medical Terminology, Medical Devices.
- Managed Phase II and III clinical trials from inception to completion.
- Established and maintains relationships with physician investigators, major pharmaceutical companies and outside academic institutions.
- Communicated closely with sponsor representatives and other research partners.
- Created, reviewed, and negotiated research budgets and contracts.
- Authored study documents and institutional review board submissions in accordance with central institutional review board and federal standards.
- Managed subject recruitment and local advertising initiatives.
- Dispensed study medications and maintained proper storage and drug accountability documentation.
Bachelor Of Arts
Clinical Research Manager III Resume
Summary : Assurance responsible for developing and executing performance and automation tests. Chemotherapy orders were followed by appropriate staff members.
Skills : Clean room trained, Excel.
- Supervised and managed employees in the day to day operation of a Clinical Research Center.
- Negotiated contracts and reviewed grants as deemed by the FDA and pharmaceutical sponsors.
- Consulted with outside entities to verify services and fee schedules.
- Maintained calendars and approved leave time for coordinators, scheduled staff meetings with team and physicians as needed.
- Developed standard operating procedures for clinical and administrative staff.
- Acted as an immediate clinical resource and liaison between staff, physicians, hospitals, clinical, and lab personnel.
- Reviewed potential new studies, completed feasibilities, and confidentiality agreements.
Assistant Clinical Research Manager Resume
Summary : Provides administrative support to the clinical research teams in the full spectrum of the research activities such as pre - clinical research, study start-up, study management, and site closure.
Skills : Trauma Research.
- Developed and managed a clinical research program and managed all aspects of patient care to provide patients with local cutting edge therapy.
- Managed all aspects of Phase II - IV clinical trials for oncology patients delivering key patient outcomes and providing the business with sound financial gains.
- Developed a partnership with the research program at the Medical College of Georgia to provide cooperative group trials through the National Cancer Institute.
- Managed as Clinical Research Manager all aspects of regulatory requirements to meet FDA standards including developing and maintaining relationships with local and central Institutional Review Boards.
- Developed and implemented training documentation for all research staff to meet FDA standards.
- Developed and coordinated weekly research meetings with principal investigator and research staff to ensure investigator oversight of all research patients and studies.
- Developed and maintained a weekly clinical trial patient list to ensure proper procedures, billing.
Master Of Science In Nursing
Associative Clinical Research Manager Resume
Summary : Ensure that the interim safety reports, interim study reports are provided to EC as per the governed regulatory body. Preparation of power point presentations for investigator meetings and Site Initiation visits.
Skills : DBMS
- Prepared and implemented SOPs and ensure adequate training of research staff.
- Completed clinical trials for the NIH, pharmaceutical companies including Pfizer, Glaxosmithkline, Medtronic, Proteon, Shire, Elcelyx and Bayer, and investigator initiated clinical trials.
- Evaluated workflow within the Department of Nephrology and redesigned tasks and projects to correct deficiencies.
- Determined resource requirements of clinical trials including budgetary, laboratory, personnel and patient availability.
- Supervised submissions and maintenance of regulatory documents.
- Provided sponsor access to clinical trials office for site visits, monitor visits, and audits.
- Reviewed study sub-contracts and budgets for financial feasibility and assist in clinical trials office- budget development.
Certificate In Clinical Research
Supervisor Clinical Research Manager Resume
Summary : Developing test cases and study data. Conducting testing for general testing of Bio Clinical products. Conducting testing for Clinical development tools.
Skills : Power point presentation
- Managed in vitro, pharmacokinetic, and clinical endpoint studies.
- Managed multi-site patient studies in oncology, schizophrenia, asthma and pediatric pain Experience in running studies.
- Evaluated and select appropriate Contract Research Organization for studies/projects for cost-competitive outsourcing.
- Managed study budgets and negotiate costing for outsourced activities.
- Executed expertise in evolving requirements for ANDA submissions.
- Developed bioequivalence strategies for new products in development including determining study design, patient population, sample size estimates, and other considerations.
- Interacted closely with R&D teams internally to provide input on formulations in development, provide regulatory guidance and to coordinate timing and availability of clinical supplies for studies.
Doctor Of Pharmacy In Pharmacy Practice Residency
Centralized Clinical Research Manager Resume
Summary : Global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs.
Skills : DBMS, SQL.
- Directed the preparation of protocols, consent forms, and initial and updated documents for FDA and IRB submission for investigator- and industry-sponsored clinical trials.
- Maintained communications with trial sponsors, Principal Investigator, Sub-Investigators, and other stakeholders.
- Updated regulatory documents and drug accountability logs.
- Monitored enrolling site performance for subject accession and initiate additional sites as instructed.
- Contributed to the review and approval of study contracts and associated budgets.
- Collected and prepare laboratory samples.
- Reviewed feasibility of potential studies and conduct follow-ups of patient recruitment efforts.
Master Of Science In Health Sciences