Clinical Research Assistant Resume
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Name:

Nakisha

Location:

US-Pennsylvania-Philadelphia

Experience:

Willing to Relocate:

Willing to Travel:

Most Recent Job Title:

Clinical Research Assistant

Personal Website:

Objective:

Please refer to CV

Resume Text:

SUMMARY OF EXPERIENCE

Multi-task projects to meet team deadlines in a challenging, fast-paced environment. Dependable experience managing diverse backgrounds. High level of comparative comprehension regarding creativity and effectiveness of brand management and executing marketing plans within a trial. Negotiating site budgets, drug shipment and patient recruitment and retention materials. Ability to anticipate problems and initiate solutions. IRB submissions and approvals.

WORK EXPERIENCE

08/2004-Present Clinical Project Assistant II
sanofi-aventis

• Feasibility; Site Selection, Study Start Up Activities, IRB submissions and approvals.
• Serves as interim CRA for routine monitoring of investigative sites, identifying and resolving root problems.
• Maintain close contact with site personnel and review of regulatory documents required for site initiation.
• Primary contact for IVRS start-up, updates, ensures site compliance, regular maintenance and granting team access.
• Review monitoring reports on site issues, and report findings.
• Review and approval of ICF; proofreading submitted advertising for recruitment of study subject, and patient retention materials.
• Assist in the development and execution of marketing strategies focusing on recruitment.
• Daily phone calls from sites and address issues in a timely manner.
• Train and supervise new hires / team members and monitor progress.
• Track and report study program progress, performs data review when necessary, for accuracy and completeness.
• Participate in the organization and execution of investigator's meetings and other related meetings.
• Communicate with Drug Manager regarding drug shipments, storage, accountability, and destruction.
• Communicated regularly with domestic and international vendors regarding investigational device shipments.
• Interact with pharmacovigilance Assuring accurate reporting of AE/SAEs, protocol deviations, and patient status.
• Primary contact for ordering of CRFs via international and local suppliers.
• Local study file start-up, track and obtain outstanding regulatory documents from sites. Assure accuracy of site regulatory files and sponsor files are current and compliant. Regular submission of documents to international regulatory team for NDA submission and preparations for audit.
• Primary contact for site contract/budget point person regarding Exhibit A negotiation, procedure costs, increasing advertising budgets, updates on availability of funds, negotiating patient visit payments for extension studies, and coordinating approval process with the legal department.
• Key role in designing financial stipulations for site budgets.
• Fundamental role in creation of study related retentions materials.
• Collect Subject Enrollment Logs tracking patient status, process grant payments, resolve payment inquiries, and maintain grant database.
• Study supplies ordered and tracked for each site.
• Prepare slide show presentations and disseminate information as necessary.
• Monthly tracking and reporting of study status to the Medical monitor.
• Able to manage multiple projects over different several operative areas.
• Complete special projects assigned by project management to achieve deadlines.
• Proficiency in IMPACT.
• Working knowledge of company SOP, GCPs, ICH Guidelines and FDA regulations.

03/2004-08/2004 Clinical Research Associate
Omnicare Clinical Research

• Feasibility; Site Selection, Study Start Up Activities, IRB submissions and approvals.
• Maintain close contact with site personnel and review of regulatory documents required for site initiation and ensuring accuracy of both client and site file.
• Primary point of contact for management to initiate initial drug shipments.
• Communicate all site progress, drug shipments, and all concerns with management until drug shipment authorization.
• Reviewing and approving ICF and HIPAA language for submission to IRB, proofreading submitted advertising for recruitment of study subjects, and patient retention materials.
• Assist in the development and execution of marketing strategies focusing on recruitment.
• Train and supervise new hires / team members and monitor progress.
• Preparing and finalizing Clinical Study Agreements budgets.
• Assuring study team, project management, line management, and sponsors are informed of progress and status.
• Provided essential documents for Investigator Meetings.
• Contacting investigator sites checking on status of outstanding documents.
• Ensuring all revised and updated essential documents are reviewed, tracked, and forwarded to the sponsor.
• Creating site initiation document templates, and coordinates distribution of correspondence for investigator recruitment.
• Routinely send all study related activities and deliverables to the sponsor in a timely manner.
• Lead CRA for piloted program for Remote Data Capture Studies.
• Strong organizational, interpersonal, and communication skills, with a high degree of accuracy and attention to detail.
• Able to manage multiple projects over different several operative areas and multitasking with strong time management skills and ability to prioritize as required.
• Working independently with minimal supervision.

11/2003-03/2004 Clinical Trial Associate
Bristol-Myers Squibb

• Supporting Multiple Global Projects working under deadlines.
• Site Management support.
• Site payment monitoring.
• Track and obtain outstanding regulatory documents from sites. Assure accuracy of site regulatory files and sponsor files are current and compliant. Regular submission of documents to international regulatory team for NDA submission and preparations for audit.
• Project coordination and site document collection and tracking.
• Train and supervise new hires / team members and monitor progress.
• Investigator Meeting Process and Organization.
• Utilizing available technology to effectively support study activities.
• Clinical Trial knowledge.
• Clinical Trial Supply Process.
• Communicating effectively using verbal and written approaches.
• Detail Oriented.
• Great Interpersonal Skills.
• Ability to Set Priorities.
• Working well with others and a great team player.
• Strong organization and time management skills.

12/2000-11/2003 Clinical Research Assistant
PAREXEL International Corporation

• Summarize and present clinical analysis to team/sponsor by accurately circulating project metrics exported from a Clinical Database on a regular basis.
• Collected and reviewed monitoring Reports and determining if further investigation is needed prior to submitting to sponsor.
• Report and track Serious Adverse Event/AEs and progress on Regulatory Document collection.
• Sends IND Safety Report information to sites and team members and maintains tracking document.
• Assists with safety reporting by exporting from Clinical Database for Administrative Reports, and routinely send SAE information to team members and maintain tracking document.
• Collect SRPs from site and review for FDA and sponsor compliance.
• Train and supervise new hires / team members and monitor progress.
• Track CRFs and communicate any discrepancies/queries with CRA and site.
• Performed study start-up for sites by collecting valuable documents and shipping start-up supplies.
• Assigned the role of ‘Database Administrator.’
• Liaison between client database (CPMS Remote Patient), helpdesk and team.
• Devised an effective way to ship and track study supplies and oversee day-to-day operations.
• Very familiar with IRB terminology, approvals, FDA regulations, HIPAA requirements, and well versed in GCP/ICH Guidelines.
• Heavily involved with investigator payments such as, site payments; patient visits and advertising payments following strict contract guidelines.
• Designed financial spreadsheets and statements.
• Providing reimbursements based on specialized unit calculations for study expenditures.
• Supports development of marketing plans and programs with client information.
• Following up with module inquiries and initiating solutions.
• Controlled data transmissions with team progress and client inter group communication.
• Edit, review and maintain team travel calendars to reflect changes and routinely post to client and team members.
• Therapeutic experience includes: Cardiovascular, Psychiatry, Depression, Anxiety and Gynecology (Hot Flashes), and Diabetes. Phase I-IIIb Clinical Drug Trail Experience.

01/2000-12/2000 Administrative Assistant
United Way of Delaware

• Maintained 150+ ADT (Alexis de Tocqueville) PGF (Personal Giving Fund) private donor finances.
• Briefed staff on collected donor information for monthly departmental meetings.
• Maintained and recorded pertinent donor information.
• Processed donor requests and disbursed money to selected 501(c)(3) agencies.
• Provided donor with updated and detailed PGF financial statement.
• Assisted Major Gifts Director with raising and surpassing membership goals.
• Applied statistical data gathered from AS400/GUI data source for marketing strategies.
• Monitored donor activity; identified problem areas, and applied solutions.
• Worked in conjunction with Major Gifts Director of Attorney and Medium and Small Business Accounts recruiting and interfaced with current members.
• Worked in conjunction with MBNA’s Loaned Executive developing procedures and streamlined department activities.
• Provided statistical reports and charts on departmental progress.
• Designed organizational Cabinet Structure.
• Traveled to meet with various board members regarding financial and business communication.
• Designed and allocated funds for the ADT promotional sporting wear intended for prospective clients and community recognition projects.
• Effectively utilized Excel; Access; Word and PowerPoint (Microsoft Suite package) and AS400/GUI (UW database).

12/1999-01/2000 Marketing Assistant
Wyeth Ayerst
• Responsible for monitoring the quality of purchased space by proofreading submitted ads.
• Reviewed copy for style, consistency, and ensuring clear and accurate messages.
• Evaluated surrounding literature ensuring supported material was not taken out of context.
• Assist in the development and execution of marketing strategies focusing on recruitment.
• Reviewed Promotional Materials, presentation Materials, and ME materials. Ensuring all propaganda meet Industry and corporate requirements have been met.
• Detecting inaccuracies by way of grammar and usage and communicating unsatisfactory exposure with team members.
• Editor oversight to vendors regarding feedback on advertising reviews, style requirements and placement.
• Able to manage multiple projects over different several operative areas.
• Oversaw coordination of traffic reviewing collected periodicals, magazines, and journals used for referencing medical advertising.
• Controlled the quantity and quality of confidential information leaving the Advertising department used for "non-departmental" reports and "public" displays.
• Prepared presentations and training material.

09/1999-12/1999 Assistant Manager, Bankruptcy Department
Beneficial/Household Bank
• Provided top-level support for Bankruptcy Manager.
• Equipped department manager with regularly updated statistical reports utilizing internal and external financial data resources.
• Primary liaison for Bankruptcy Attorneys and in-house management.
• Train and supervise new hires / team members and monitor progress.
• Supervise data entry staff in regards to promotions and project completeness.
• Key supporting role providing time sensitive and classified information exported from financial Intranet database.
• Updated accounts while keeping in accordance with client special needs and deadlines.
• Responded to generated statistical reports to develop and implement bankruptcy techniques for clients.
• Provided statistical reports and charts on departmental progress and need for special projects.
• Controlled the quantity and quality of confidential information leaving bankruptcy department used for "non-departmental" reports and "public" use.
• Created and circulated newsletters for processing accounts.
• Authorized to QC/audit data entry department progress to ensure complete accurateness.

12/1998-09/1999 Office Manager
Pennsylvania Institute of Technology
• Responded to generated statistical reports used to develop and execute recruiting techniques for prospective students.
• Manage multiple projects over different several different marketing demographics.
• Involved with the hiring and training of work-study student for front desk management and phone coverage.
• Train and supervise new hires / team members and monitor progress in regards to projects and work hours.
• Supervised student staff and monitored progress.
• Directed all data entry in Admission's Office database for director approval.
• University recruiting representative for conventions and Job Fairs applying marketing strategies set forth by the admissions department.
• Redesigned admissions recruiting brochure detailing PIT's mission statement, courses, and extracurricular activities.
• Administered placement exams and tabulated examination scores to determine if remedial courses were essential in becoming a successful student.
• Oversaw the security, maintenance and proper use of placement examinations.
• Hosting evening study-a-thons, and other events.
• Circulated new and returning student data to entire staff and suggested alternatives to existing recruiting "plugs".

EDUCATION
• Currently working on MBA for Pharmaceutical Business at the University of the Sciences in Philadelphia

• B.S. Business Administration/Marketing, 1999
• Cheyney University of Pennsylvania Cheyney, PA

• Heidelberg High School/Business, 1994
• Heidelberg, Germany; Unit 29237; CMR 419; APO AE 09102
o JROTC Color Guard Commander
o Unit Leader-20 Direct reports
o Cadet of the Year Award
o Cadet of the Quarter Award
o Cadet of the Month Award

AFFILIATIONS
• Drug Information Association
• Society of Clinical Research Associates (SOCRA)

SKILLS & TRAINING
Ability to think strategically to move a project forward. Able to manage multiple projects over different several operative areas. Cognizant of time-per-task and deadline focus. Written communication skills. Tracking progress and broadcast project activity among colleagues, and Strong organizational, interpersonal, and communication skills, with a high degree of accuracy and attention to detail.

• TRAINING & WORKSHOPS
• ESubSTAND10 FDA Submission Documents
• Drug Accountability Workshop
• Regulatory Document Binder Review and Maintenance
• Electronic File Back-up: Zip Drives and WinZip
• Serious Adverse Event (SAE) Review
• Understanding Laboratory Values
• FDA Inspections
• Interview Skills
• Sponsor Audits
• 21 CFR Part 11 Awareness Training
• Expediting Site Regulatory Package (SRP)
• Successful Site Management
• Time Management Fundamentals
• Database Administrator Training
• HAZMAT Training
• Fraud in Clinical Research
• Phase IV Studies
• Clinical Operational Guideline Training
• GCP: Meeting the Expectations
• Responding to Site & Central Files Audit Reports
• Clinical Trial Tracking System
• Phase I (Clinical Pharmacology) Trials
• Informed Consent Challenges
• Data Management
• Overview of Investigator Contract Management Group

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