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Clinical Research Manager Resume Samples
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6-10 years of experience
Oversee scientific testing and financial affairs to support clinical trials. Manage all biochemical assays, training and development of staff (including research assistants), laboratory operations, and budgeting/accounting. Verify and enforce
compliance with quality control guidelines and IRB rules.
- Increased yearly lab revenues by $250K – $390K by running and managing renal plasma flow (RPF) and glomerular
- Managed a researched study that found sodium restriction was associated with an increase in OA peak and mean systolic
- Managed a clinical trial for Vitae Pharmaceuticals that showed how VTP-27999 drug slowed progression of chronic
- Participated in the creation of an abstract appearing in the Journal of the American Society of Nephrology
0-5 years of experience
Duties included review and total management of Phase II-IV clinical trials along with novel throm- bolytic PI research.
- Provided cardiac healthcare to 2.8 million people by six independent physician run cardiac groups.
- 24 hour on call status, code management while awaiting emergent cardiac intervention and coordi- nation of incoming acute cardiac patients from rural areas.
- Designed and conducted original research evaluating women’s cardiac health. Research accepted for presentation by The American College of Cardiology and The American Heart Association.
0-5 years of experience
Managed 3 international Phase One studies, 8 Phase One studies and 2 Phase 3 studies
- Initiated and facilitated Phase 1-3 studies domestic and international
- Contributed in collaboration with the Project Leader for the development and maintenance of the Clinical Development Plan
- Worked with Safety Department in reconciling safety data
- Managed Lead CRA and /or CRO in their conduct of the day-to-day operations of clinical studies including the drafting of protocols, operations manuals, CRFs, informed-consent form, and other documentation required for regulatory submissions.
- Reviewed data query resolution, tables and listings review, and final study report from various vendors contracted to facilitate clinical trials.
0-5 years of experience
Initiated all aspects of the clinical trials department for the private general oncology practice of thirteen physicians.
- Provided clinical trial communications, regulatory compliance and contract/budget negotiation.
- Coordinated, monitored and managed all activities of nursing, pharmacy, accounting, administrative and supportive staff in accordance with Good Clinical Practice guidelines.
- Participated in international investigator and coordinator meetings throughout the country.
- Collaborated with advanced practice nurses and physicians while conducting pre-study visits, staff orientation, study start-up, drug accountability, patient screening and data collection; enrollment follow-up, data entry, query resolution, study closure and reimbursement while maintaining strict HIPAA regulations.
- Oversaw all trials conducted directly with pharmaceutical companies as well as in partnership with McKesson Pharmaceuticals U.S. Oncology Research and the Midwest Melanoma Partnership.
0-5 years of experience
Developed and implemented standard operating procedures (SOPs) in 20 study sites.
- Managed clinical research protocols, assured compliance with federal and local regulatory and clinical agencies and Institutional Review Boards (IRBs); assured safety and wellbeing of study participants.
- Conducted site monitoring visits to ensure clinical aspects of study were carried out in accordance with the protocol and Good Clinical Practice (GCP) guidelines.
- Identified, recruited and managed clinical partners and external vendors including biorepositiories.
- Developed project metrics and budget; tracked progress and expenses.
- Prepared study progress reports. Developed and implemented risk mitigation processes.
- Trained and certified study staff; supervised research staff.
0-5 years of experience
Played a key role in planning and executing Phase I, II and III Pulmonary drug trials – National Heart
Lung and Blood Institute- Acute respiratory distress syndrome (ARDS) network trials (SAILS trial,
feasibility study of Allogeneic Bone Marrow-derived Human Mesenchymal Stem Cells) Sponsor trials
(ALTOR- ALT 836) and PI-initiated drug studies (EALI and LIPS A)
- Established reputation as high performer in implementing the clinical trials
- Led the successful implementation of complex study protocol, including the precise and comprehensive details of the trial. Met increased responsibilities with timely and accurate completion of required study and regulatory documentation.
- Determined the inclusion and exclusion criteria and screen for potential unanticipated adverse events from the protocol by reviewing and analyzing hospital charts of complicated critically ill patients
- Reviewed and maintained accurate billing and provided input to the study budget
- Facilitated training and delivered in-service presentations to the intensive care unit (ICU) and on the floor nurses, Pulmonologists, Fellows and other Critical Care Doctors
- Ensured proper maintenance of regulatory compliance in coordination with center, IRB and FDA
- Created and updated the drug accountability log
0-5 years of experience
Played a major role in restructuring the research department and establishing procedures, including the development of Standard operating procedures, and infrastructure per regulations
- Served as head of the department from march 2011 and supervised a team of four coordinators and two interns
- Procured several new trials for the site through diligent research and persistent networking.
- Negotiated budget and contracts with sponsors
- Worked closely with IRBs at several stages of study for approvals, change of status notifications and deviation reporting
- Monitored regulatory and subject binders since mar/2012 in order to make sure site and sponsor SOPs are being followed in addition to FDA guidelines
0-5 years of experience
Directed over 20 research staff including clinical research coordinators, research associates and MA/lab personnel
- Marketed studies to the community, service organizations and clinics
- Developed a transition program from current practices towards the FDA’s risk management monitoring program
- Designed an employee skills matrix for analysis of employees and skills required to satisfy new research projects
- Researched scientific data bases for appropriate available research studies which matched corporate skill sets
- Created matrix reports that analyzed productivity, participant study ratios and financial contribution
- Current GCP training
0-5 years of experience
Created and executed recruitment plans, determined and secured trial logistical needs in terms of staff, space and external resources, accountable to sponsor and PI for meeting established goals, responsible for IRB requirements for multiple protocols.
- Coordinated Alzheimer’s disease prevention trial with over 400 participants for 6 years
- Recruitment involved mail or telephone contact with over 600,000 prospects, generated database used for recruitment in subsequent studies.
- Forged positive collaborative relationships with Departments of Radiology, Neurology, Imaging Sciences, Brain/Cognitive Sciences to facilitate participation in the Alzheimer Disease Neuro-imaging Initiative (ADNI).
- Highest enrolling site for Alzheimer Disease Cooperative Study (ADCS) Prevention Instrument Protocol study generating ~ $600K for program.
- Developed highly successful recruitment strategies, fastest enrolling site on multiple trials with high retention rates.
- Initiated African American outreach program, which resulted in increased minority participation in research studies.
- Coordinated with local Alzheimer’s Association around referrals and support for study participants/families.
- Ensured timely and accurate data collection, responded to sponsor audits and created corrective action plan if needed
- Oversaw 40 North American research sites for Huntington Disease clinical trial.
- Wrote press releases and organized teleconferences when study results were made public.
0-5 years of experience
Managed 26 clinical employees
- Designed and implemented a new clinical research model to allow for better workflow of documents, staff responsibilities, and patient care
- Research model also improved staffing needs of new and existing studies, the tracking and reviewing of testing results for sponsor studies
- Developed and monitored annual budgets for seven departments
- Reconciled monthly expenses and income for income for clinical research department
- Oversaw daily patient care, dispensing of study drug to subjects and monitoring drug accountability for sponsors
0-5 years of experience
The primary goal of this position was to establish, grow and maintain an efficient, compliant and profitable regional location. In addition, I was sent to other regions to augment their efforts in both patient and physician recruitment. My diligence and ability to deal with other regional managers resulted in my promotion to Senior Manager, USA QA.
- Identified and assessed potential investigational sites to qualify physicians for regional network of participating doctors
- Prepared and presented marketing materials depicting the Neeman Medical Model
- Prepared research-naïve physicians and their sites for the proper conduct of clinical trials
- Collected all necessary documents for Regulatory Agency and Sponsor
- Identified, hired, trained and managed qualified site personnel based on corporate budget targets to complete awarded projects
0-5 years of experience
Kennesaw, Georgia 4/2000-11/2003
United Healthcare Organization providing clinical trial research to pharmaceutical companies
Clinical Research Manager/Grants Administration
- Managed site budgets exceeding $65.4M for twelve global clinical research studies (phase 2-4) involving 500+ investigators simultaneously.
- Negotiated site contracts and budgets adhering to the sponsor’s Standard Operating Procedures and Protocol.
- Attended Investigator Meetings with various sponsors to ensure a smooth study start-up.
- Created budget proposals based on Schedule of Assessments and Scope of Work outlined in the Protocol.
- Attended project planning meetings and conference calls on a weekly basis.
- Prepares spreadsheets, PowerPoint presentations and various reports for the Project Manager and sponsor.
0-5 years of experience
Penn Medical Laboratory/[company name]
1. Coordinated clinical studies (i.e. federally funded, sponsored, internal) for reference lab related functions from trial inception through termination.
- Developed biospecimen inventory storage, retrieval, and disposal database using a barcode system to track sample location and document sample quantity.
- Developed administrative systems to track and monitor procedures which reduced redundancies and improved workflow and accountability.
- Develop and managed specimen accessioning and processing procedures; LIS data management, analysis, and reporting.
- Supervised study coordinators and specimen processing staff, developed clinical study protocols, prepared study proposals and IRB submissions.
- Created training packages, lab manuals, and study test kits for trial sites.
- Created and maintained study files and folders.
- Functioned as the clinical research business manager, compliance officer, client services liaison, and financial manager.
- Maintained CAP and CLIA accreditation, ensured implementation of GLPs, established quality control program, and created SPOs for regulatory compliance.
0-5 years of experience
Managed NIH and pharmaceutically sponsored multidisciplinary clinical research studies from start up to closeout.
- Developed, wrote and managed investigator initiated study protocols.
- Ensured study adherence to all regulatory matters and sponsor requirements according to FDA regulations, GCP and ICH guidelines. Assisted in patient recruitment.
- Screened study patients and coordinated all study activities as required by the study protocol.
- Effectively maintained both study drug and device accountability as well as documented and reported all AE’s and SAE’s to sponsor and the IRB. Functioned as regulatory coordinator.
- Ensured accurate data collection and entry to CRF’s.
- Managed research databases and prepared reports as required. Managed and tracked research funds. Worked side by side with The Office of Sponsored Research regarding any research related budget activities.
- Supervised and mentored graduate students, research assistants and coordinators.
- Presented lectures in clinical research to graduate students in the College of Biomedical Sciences.
0-5 years of experience
Progressively responsible research management professional tasked with project management, grant proposal writing, and team leadership.
- Managed all facets of project management for multiple research projects.
- Supervised up to five Research Associates.
- Authored and edited grant proposals, research protocols, research/technical reports, and ethics board applications.
- Edited articles for publication in professional scientific journals.
0-5 years of experience
Responsible for overseeing a team of 5-8 people while doing drug and device clinical trails
- Developed working budgets for each clinical trail and upheld the highest standards for each clinical trail
- Proficient in all documentation/record maintenance/paperwork to ensure accuracy and patient confidentiality, with a working knowledge of various computer systems and programs
- Provided mentoring, guidance, and education to new hires and exiting staff
- Responsible for hiring and firing of staff and worked on policies and procedures manuals for the company and Reported directly to the Vice President of the company
0-5 years of experience
Designed, supervised and developed strategies for Cardiovascular and Endovascular clinical device trials
- Managed Endovascular medical device protocols according to all applicable regulations, company procedures and to high ethical/quality standards
- Developed and managed clinical strategy, execution of clinical trials, data coordination/management and reporting of results
- Primary contact for internal customers (marketing, regulatory affairs and research project teams) and external customers to provide technical consultation as appropriate
- Selected and managed vendors including data management and monitoring contract research organizations (i.e. monitoring CRO, data management CRO)
- Hired, evaluated, developed and managed direct reports and other clinical personnel
- Identified and led process improvement activities within the department
- Participated in cross-functional process improvement/compliance activities
6-10 years of experience
Clinical Trials Office, Dallas, TX
Clinical Research Manager, Internal Medicine 05/07- Present
Responsible for research project management including project development, budget and contract
negotiation, feasibility evaluation, regulatory submissions, and personnel assignment, identification of new projects and grant opportunities, preparation of annual budget forecast and assessment of budget
shortfalls. Liaison between internal and external clients, sponsors, funding sources, community, and regulatory agencies. Responsible for personnel oversight including interviewing, hiring/contracting and
terminating of employees and/or contractors, orientation and training, performance evaluation, and development of corrective action plans. Performs ongoing review of internal policies and standard
operating procedures to assure all applicable regulatory and ethical standards are met, conducting in- house monitoring of study binders, source documentation, and regulatory documents internally and on
assignment to other divisions, serving as a mentor among colleagues. Prepares and conducts team
meetings for review of recruitment milestones, project timelines, and identification of action plan.
Provides consultation services to campus faculty, staff, and students regarding the application and implementation of federal regulations, state laws, and institutional policies governing clinical research and participates in committees to identify needs for improvement and design coordinator education
opportunities. Professional highlights include:
- Organized and directed first-in-kind patient/caregiver symposium to highlight Pulmonary Fibrosis research
- Founder/Director of only IPF patient support group in metroplex
- Conducted study coordinator group “Lunch and Learn” to provide networking opportunities
- Served on committee for implementation of electronic clinical trial study management
- Currently developing CME event for area pulmonologists to further idiopathic pulmonary fibrosis
0-5 years of experience
Administrative and Laboratory Manager. Primary Liaison with Multinational Pharmaceutical Companies.
- Coordinated multiple complex Phase II-III Central Nervous System trials.
- Trained Research and Administrative staff. Responsible for Protocol implementation, Patient recruitment (300 total) and follow up.
- Coordinated Study related Outpatient Surgery bookings with Plastic Surgeon.
- Pre, peri and post-operative coordination of study patients. Processing and shipping of trial-related surgically harvested Sural nerve specimens, pharmacokinetic and laboratory specimens.
- Managed and maintained clinical drug supplies.
- Responsible for training other study sites at Multiple International Investigators meetings for a Leading multinational Pharmaceutical company.
0-5 years of experience
Coordinated the clinical projects as team lead and made sure that Case Report Forms (CRF) were reviewed in a timely fashion and submitted to the data management group.
- Planned the clinical surveys with the lab service coordinator.
- Interacted with the sponsors and clinical investigators.
- Administered medical health surveys.
- Maintained medical files, records, reports, and statistical data.
- Oversaw clinical trials to ensure the participants met criteria and that Good Clinical Practices (GCP) was followed.
- Maintained patient confidentiality when handling paperwork and records.
0-5 years of experience
Responsible for planning, initialization, management, and oversight of all clinical trial activities across the company, one of the top 10 Urology practices in the United States.
- Successfully established a company wide foundation for a Clinical Research Division
- Supervise and provide guidance to a team of 15 Research Coordinators in 10 [company name] locations in the Carolinas
- Generated in Clinical Research revenue within 1 year
- Successfully managing 13 Clinical Trials company-wide, with over 90% compliance at all participating locations
- Daily responsibilities include building and managing relationships with Sponsors, Principal Investigators, among others
- Managing contract negotiations, budget and revenue cycle reporting, IRB submissions and Continuing Reviews
0-5 years of experience
Immunotherapy Program
- Managed the development, operations and regulatory needs of multiple Phase I/II clinical trials in accordance with departmental SOPs, GCP and ICH guidance.
- Maintained regulatory documentation for all active studies; coordinated multi-site studies.
- Facilitated document sharing with cooperative group and external research sites; provided
- Developed and processed study documents for institutional committee reviews; composed
- Prepared IND safety reports; reported serious adverse events to the FDA, institutional PPHS,
- Managed research contracts and collaboration agreements; primary liaison for Cancer Clinical
- Provided administrative and financial support; responsible for fund management and project
Gabriela Barcenas
CPRW, Content Writer IIGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
