Customer Service Project Manager
Resume:
SUMMARY
Established successful interdisciplinary skills serving
pharmaceutical, biotech, health care and clinical research companies.
Extensive work & academic experience covering clinical study, database
management, clinical documentation, protocol enforcement, regulatory
and quality compliance.
Education
Rutgers University, New Brunswick, NJ
B.S. Biological Sciences
SKILLS
Proficient in MS Office Suite (Word, Excel, Access, Outlook, Power
Point) email & voicemail, processing of serious adverse events forms
(SAE), project management experience, clinical supply experience, GCP,
ICH, health care compliance, proven successful quality assurance
commitment, knowledge of FDA regulations, Adobe, CTMS, ARGUS
database, CRFs, document management, proofreading skills, Word
Processing, Global Safety Database, demonstrated analytical & problem-
solving skills, advanced medical terminology, workingly knowledge of
clinical drug development process, AE requirements/process, ability to
follow SOPs and regulatory guidelines, strong data Entry and tracking
skills, ability to analyze and implement solutions, ability to read,
interpret safety procedures and communicate effectively.
- Proven strong attention to detail and customer service focus;
excellent communication, presentation, documentation,
organizatioanl & interpersonal skills
- demonstrated ability to work successfully independently, & in a
team as well, & handle multiple deadline driven tasks in a dynamic
fast-paced environment
Experience
COVANCE, INC
March 2012-Present
Princeton, NJ
In-House CRA
Successfully managed complex Phase II-IV clinical studies with
neurology/psychiatric indications in compliance with the protocol, SOP,
FDA, ICH, and GCP regulations for clinical conduct. Hybridized CRA
performing all aspects of clinical trial support including Project
Director, Project Manager, Lead CRA and CRA responsibilities to utilize my
diverse background. Responsible for all aspects of study site monitoring
including pre-study, site initiation, routine monitoring (RMV) and close-
out visits (COV) of clinical sites and effectively prepared accurate and
timely trip reports.
. Ensured proper reporting of Adverse Events (AEs) and SAEs from the
Site to the Sponsor and IRB/IEC
. Verified IP accountability
. Successfully performed source data verification (SDV) of Case Report
Form (CRF) review as well as query generation and ensuring resolution
. Efficient at reviewing accuracy and completeness of site study files
and TMF
. Lead CRA and Project Management/Project Director leader specialized
in managing study budgets, financial payments, reviewing and editing
critical clinical study documents and plans, managing critical Data Sweep
periods and expired drug/ancillary supplies to ensure adequate supply on-
site, tracking early termination patients' post-study follow-up, overseeing
drug labels, serving as primary contact for Q&A Log between Sponsor and
team, and addressing issue resolution with the Sponsor and other Lead CRAs
. Trained and mentored entry-level CRAs of global program team to
ensure compliance
. Created and implemented a COV Checklist to reconcile Study File
Notebook (SFN) documents and TMF documents at RMVs to be more proactive
than reactive at the COV
. Process improvement advocate resulting in cost savings for study
. Reviewing sponsor template and site level Informed Consent Forms (ICF) to
assure compliance with Good Clinical Practices (GCP) and ICH guidelines.
. Participating in the regulatory review, preparation, and submission of
clinical study documentation (e.g. investigator brochure, IND/IMPD, etc.)
as required.
. Arranging for receipt and/or transmission of administrative and
regulatory documents and SAE reports.
. Reviewing FDA form 1572
. Reviewing Study File Notebook & Regulatory Binder
. Providing timely follow-up, issue resolution, update reports and problem
escalation as necessary.
. Attending study team meetings & sponsor meetings as required.
. Maintaining overall awareness in the field of clinical research, as well
as assigned areas, by reading related literature, attending training
classes, attending professional meetings, etc.
. Responsible for performing study activities regarding the management and
verification of medical consistency checks (MCC) and ensuring patient
safety and adherence to protocols, Good Clinical Practice (GCP), ICH
Guidelines, federal regulations and SOPs
. Accountable to ensure that clinical investigative site staff adhere to
the implementation of patient safety or data integrity
. Responsible for high quality medical data through the medical review of
clinical trial data
. Close collaboration with other members within Clinical Trial Management
(CTM) with focus on program managers and data managers and vendors
. Maintaining successful external relationships with clinical
investigators, and other clinical research vendors as needed to support
business objectives for the department and/or function.
. Proven thorough understanding of study management tasks and
responsibilities necessary to implement compliance with
protocol/regulatory requirements and SOPs.
. Attending Investigator Meetings and study-specific training for assigned
trials
. Responsible for communicating issues in accordance with the CTM
escalation pathway PM as appropriate
. Developing and maintaining collaborative working relationships with
clinical investigative sites and study clinicians. Accountable for data
integrity, patient safety and regulatory compliance for assigned
activities
. Ensuring that all data is captured in the eCRF or CRF in a timely manner.
Ensuring any queries generated on the data are addressed in a timely
manner with the sites and with Data Management (DM)
. Responsible for assuring adequate and appropriate dissemination of
information according to the study specific communication plan between
project team members to ensure project success in accordance with the
Project Specific Communication Plan
. Understanding of assigned protocol (s) and trial specific manuals/plans
to ensure quality and deliverables are met across assigned sites
. Provided active mentorship of CTM staff to build talent across the
department
. Responsible for ensuring that the mandatory trial entries are made in EDC
administration, IVRS and updates, E-TMF/E-CTMS, LOTUS NOTES, SHAREPOINT
and ensure CSIM entries and updates are made.
. Demonstrated computer skills (MS Office, MS Project, PowerPoint).
. Demonstrated core understanding of medical terminology and clinical trial
activities in relation to execution of a clinical development plan.
. Working knowledge of GCP as relates to clinical trial managementAct as
contact for project team and study sites.
. Travel to sites for conducting co-monitoring visits
. Understanding and establishing thorough familiarity with assigned study
protocol
. Assisting Senior CRAs with on-site tasks as required and according to
training goals (e.g. review of Case Report Forms and Study File Notebook,
drug accountability)
. Perform CRF review, query generation and resolution against established
data review guidelines, under direct supervision
. Assisting with generation and reconciliation of queries to investigative
sites/clients to resolve problem data
. Understanding and meeting/exceeding the needs of patients, study
sponsors, monitors, auditors, multidisciplinary team, etc
. Create, update, track, and maintain study-specific TMFs tools, and
systems
. Ensure compliance with SOPs, FDA, ICH, and GCP regulations for clinical
conduct in all aspects of daily work
. Initiate, monitor and close out clinical investigative sites under direct
supervision
. Site & Query Management - making weekly calls to sites, ensuring detailed
documentation of calls
. Recruitment Discussion - challenges and provide best practices used by
other sites to find patients.
. Study Supplies - Route supply requests to CPA
. Drug Supply - Ensure automatic drug supply is meeting sites recruitment
needs. Escalate drug supply issues to project management team
. Lab Kit Supply - Ensure automatic kit supply is meeting site recruitment
needs. Escalate kit supply issues to project management team.
. Lab Sample Shipment - Ensure site is shipping lab samples according to
the specifications within the lab manual.
. EDC Access - Ensure all site team members have completed training and
have been provided with access.
. Outstanding queries - Advise the site regarding the number of queries
outstanding and provide a deadline for completion of the queries.
Escalate questions regarding queries to project team
. IVRS/IWRS Review - IVRS/IWRS against EDC to ensure consistency, provide
site and team access, remove inactive site member access.
. Visit Preparation & Visit Follow-up - Preparation of confirmation letters
and follow-up letters for visits
- creating, formatting and sending out the confirmation and/or follow-
up letters on behalf of the CRAs, and tracking and filing the letters
. RMV Preparation - pulling of action items, EDC and IVRS reports, among
other items, to help with RMV preparation
. Patient Eligibility Assessment Forms - working closely with project team
Medical Monitors & site on: communication, follow-up, documentation and
tracking
. Patient Lab Alerts - working closely with project team Medical Monitors &
site on: communication, follow-up, documentation and tracking
. Assisting in compiling & streamlining clinical study procedures
. Assisting in compiling & streamlining drafts of routine correspondence
SAINT PETERES UNIVERSITY HOSPITAL
New Brunswick, NJ
Nursing Unit Secretary
February 2011 - February 2012
o Patient registration
o Working knowledge of relevant clinical data
o Working knowledge of processing/entering clinical data
o Setting up admission and discharge charts on patients
o Inputing doctor's medication orders into the computer
o Interacting & providing excellent customer service with patients,
patient family members
o Understanding and meeting/exceeding the needs of all patients,
patients' families & visitors, nurses, doctors, medical/clinical team
o Serve as in intermediary for communication between staff members of
the Labor & Delivery department, as well as patients and staff
o Communicating patient information, manually and electronically, to
appropriate healthcare providers
o Entering patient orders electronically
o Prioritizing the flow of patient information to all areas
o Acting as a centralized communication facilitator for the patient care
areas
o Keeping patient information confidential
o Exercising professional judgment in performance of services and
maintaining demeanor complementary of medical ethics
o Treating colleagues, customers, patients and families with respect,
loyalty and dignity
o Actively supporting the operations of the nursing unit.
o Performing clerical functions in compliance with hospital policies and
procedures
o Responsible for courteous, accurate and timely communication of
information
o Taking messages accurately and relays them immediately
o Maintaining unit based logs on patients for patient admissions,
transfers and discharge
o Demonstrating proficiency in computer order entry with 95% accuracy
o Answering telephone in a courteous and professional manner stating
name, title and unit.
o Routing telephone calls to the appropriate individual
o Ordering and maintaining par level on unit supplies, forms, handouts
on a regular schedule
o Keeping Health Information Management files/forms in orderly,
organized fashion
o Obtaining equipment such as beds, pumps, etc as needed by nurses
o Inputing patient charges into computer for all designated chargeable
services provided on the unit
o Attending to tube station by sending and distributing medications,
paperwork, etc.
o Appropriately accessing secured rooms with medications storage
containers in order to perform assigned job function
o Printing off patient discharge instructions as needed. Communicateing
patient discharges and transfers to appropriate personnel
o Discharging patients immediately from computer upon patient leaving
the unit
o Notifying housekeeping of rooms to be cleaned promptly after patient
discharge
o Communicateing/handling Physician/Patient orders and information
appropriately and accurately:
o Entering all physician orders including medication orders
o Notifying nurse of new electronic patient orders and/or all 'stat' and
now' orders
o Notifying departments of special orders
o Acting as a resource person for staff and physicians regarding input
of orders
o Identifying policy violations and refers to Charge Nurse/Primary Nurse
(e.g. orders with unapproved abbreviations, orders to resume
all/continue, etc)
o Entering clinical information and/or physician orders into the unit's
computer documentation system such as Meditech accurately
o Maintaining chart organization including all required forms:
o .Demographics
o .Flowsheets
o .Diagnostics reports/information: Lab/X-ray reports
o .Resuscitative status orders.
o Preparing charts for new patients; and organize charts for discharged
patients following the Health Information Management policy/protocol
o Ensuring copies of patient records ready for transfers
o Providing assistance, guidance, and direction to patients, visitors,
nurses and physicians in a professional manner
o Interacting with family members as needed, in a customer-friendly
atmosphere
o Providing accurate information to all customers, while maintaining
compliance with patient confidentiality standards
o Being knowledgeable of the emotional, spiritual, religious and
cultural support aspects when dealing with patients and their
significant others
o Answering call lights and refers to licensed nurse, as needed
o Promptly greeting individuals entering the unit and offers
assistance/directions
o Instructing transporters to sign patients in and out of transportation
log
o Assisting with sending specimens to lab as needed
o Following hospital's universal precautions standards
o Maintaining professionalism in job duties and interacting with others
to develop respect and trust
o Acting as a resource person regarding equipment, including, but not
limited to, computers, printers, fax, phone, and paging systems
o Maintaining confidentiality about all hospital matters
o Assuming responsibility for unit specific training and verifying
competency of new unit secretary users on the computer for order entry
o Completing unit secretary's competency checklist, age specific
competency requirements, and annual mandatory education
o Attending unit meetings and inservices
o Adhering to the hospital and unit policies and procedures
o Performing other duties in the Department as required
UMDNJ-RU EOHSI BRTC January 2009 - May 2010
Piscataway, NJ
Scientific Research Assistant
http://www.eohsi-brtc.com/frontend/index.php
Research assistant at BRTC, a company committed to facilitating and
enhancing both basic and clinical science programs by providing complete
high-technology solutions in the post-genomics era. Through a series of
comprehensive education, technology development and service programs the
BRTC will support primary investigators in the development, implementation
and analysis of high throughput genomics -based technologies including but
not limited to DNA, RNA, protein and the metabolite. Through a series of
data fusion and common analytical approaches tools developed within the
BRTC will be available to help accelerate the discovery process in basic
science (mechanism of disease), prognostic indicators and clinical
diagnostics.
. QPCR and Real-Time PCR experiments for clinical and molecular
diagnostics clients
. Data collection/entry/processing
. DNA distributions by robotic automation Biomex FX, QC of DNA samples
. Transgenic mouse genotyping and determination of genetic zygosity
. Collection and storage of clinical blood and tissue samples, Biosafety
Level 2 training
. Scientific data processing and analyzes of scientific reports follow
GLP and SOP
. DNA/RNA extractions by robotic automation
. Mycoplasma detection by QPCR methods
. DNA sizing By Caliper AMS 90 LabChip
. Trained three new employees
. Maintenance of Lab inventory supply/database
. Experience troubleshooting problems and equipment related to DNA
distributions.
. Assisting with compilation Standard Operating Procedures (SOPs)
VOLUNTEER WORK
Saint Peters University Hospital Volunteer
11/10 - present
http://www.saintpetershcs.com/Services/OtherServices/CommunityOutreach/Volun
teerServices.aspx
. Making the hospital experience as pleasant as possible for patients and
their families
. Provide hospital staff with support whenever and wherever possible
. Delivering mail, flowers, books and magazines to patients' bedsides
. Serve as a Pharmacy courier to nurses' stations
. Provide comfort care to patients in the Ambulatory, Emergency and
Oncology departments
. Provide administrative assistance via clerical needs for various
departments
Lotus Medical Center Medical Assistant Volunteer
06/10 - 01/11
. Assisted staff/office in all proceedings as needed, such as
receptionist/front desk work, filing, checking patients in/out, taking
patient vitals, taking patients to back room, acting as a communication
liaison between staff members
. Clinical/direct hands-on patient care experience
Women's Heart Foundation Chief Volunteer
08/06 - 12/07
http://www.womensheart.org/
. Designed/implemented heart disease prevention projects
. Assisted with charitable events dedicated to education on improving
survival and quality of life
. Assisted in data collection, data processing and data entry for clinical
studies
. Educated women about heart disease & its effects in daily life: economic,
cultural, physiological, psychological and spiritual
. Educated health professionals concerning the unique needs of women with
heart disease
. Advocated research in the diagnosis, prognosis, treatment & outcome of
heart disease as it affects particularly minority women
. Supported women as caregivers
. Actively conducted and participated in all aspects of the Teen Esteem
Wellness Program
http://www.womensheart.org/content/outreach/TeenEsteem/whatis_teenesteem.a
sp
References:-
1. Esther Nkrumah (DHSc, MS, CCRP)
Currently: Director, Clinical Research Management at Drexel University
College of Medicine
Previously: Line Manager (my immediate supervisor) at Covance, Inc
********@*********.***; *************@*****.***
2. Joyce Bennett-Looney (MS, PMP)
Clinical Team Lead at Covance, Inc (Princeton, NJ)
******@*****.***
3. Soma Sarkar (MBA, MS)
Clinical Team Lead at Covance, Inc (Princeton, NJ)
***************@*****.***
4. Lydia Lefchuck (MSc)
Nurse Manager at Saint Peters University Hospital (New Brunswick, NJ)
732-***-**** ext.5038
5. Irina Aranovich (MS)
Lab Researcher IV at UMDNJ-Rutgers EOHSI BRTC (Piscataway, NJ)
*********@*******.***; ********@*****.*******.***
Contact this candidate