Joanne DiNatale, RN BSN CCRC

**** ********* *****, ********, ** 18062

Mobile: 908-***-****/ acy9ne@r.postjobfree.com

SUMMARY

Registered nurse, New Jersey native, with 25 years of clinical/research experience, currently residing in the Allentown, PA area. Currently seeking a leadership opportunity at the industry or academic medical center level with relocation to the NY/NJ metropolitan area. Experience includes over 12 years of diverse clinical research responsibilities which includes managing clinical research site operations, quality and compliance monitoring, and personnel management. Managed over 50 FTEs in the role of patient care coordinator. I am confident that my experience working in a fast paced, regulated environment and my ability to manage multiple people and projects, while still providing superior service to customers, will lead to success as part of a dynamic team.

EDUCATION

Chamberlain College of Nursing Masters Science in Nursing

St. Louis, MO May 2016 – in progress

Chamberlain College of Nursing Bachelor of Science in Nursing

St. Louis, MO December 2013 – May 2015

Union County College Associates in Applied Science

Cranford, NJ January 1988 – May 1991

Elizabeth General Medical Center School of Nursing Diploma in Nursing

Elizabeth, NJ 07202 January 1988 – May 1991

WORK EXPERIENCE

Lehigh Valley Health Network, Allentown, PA August 2013 – Present

Clinical Research Coordinator II

Conduct phase II-IV clinical device and drug studies according to FDA regulations, GCP guidelines, and site SOP's for the division of neurosciences and neuro-interventional radiology.

Recruitment, coordination, assessment and care of patients enrolled on trials, including administration and scoring of psychiatric and cognitive rating scales.

Conduct quality assurance reviews/audits to ensure protocol compliance, verify accuracy of clinical trial data, adherence to applicable regulations, SAE reporting, CRF completion and query resolution.

Assist Monitors/CRAs during pre-qualification, site initiation, ongoing, and close-out monitoring visits.

Protocol review for feasibility to determine needs for study staffing and implementation.

Participate in local and central institutional review board (IRB) submissions.

Review and implementation of site’s standard operating procedures (SOP)

Assess and train new staff in departmental operations and SOPS.

Apply knowledge of FDA regulations, guidance, and ICH-GCP, including the protection of human research subjects, to the reporting requirements for adverse events, obtaining informed consent, and other regulatory activities.

Participate in the design and content development of patient informed consent forms (ICF).

Work with contract research organizations (CRO), sponsors, and Principal Investigators (PI) to review timelines and strategize recruitment methods for studies to ensure that performance expectations are met.

Validate potential patient data against pre-established inclusion/exclusion criteria to verify eligibility.

Order as appropriate and distribute study medication according to the protocols’ requirements maintaining accurate and complete accountability records

Maintain Investigator Trial Master Files ensuring all appropriate regulatory documents were completed, updated/revised as necessary and filed appropriately

Triage adverse event information for seriousness, expectedness, FDA reportability, and prioritize follow-up activities needed. Obtain follow-up information from consumers and health care providers and work with PIs to finalize reports for submission to sponsor and local IRB.

Serve as initial sponsor contact for SAE reconciliation.

Review and complete paper/electronic case report forms (CRF) entries and query resolutions with different EDC software.

Serve as liaison between care providers and patients

Participate in internal and external training programs, meetings, and attend conferences to continually improve and build knowledge.

B. Braun Inc. – Bethlehem, PA February 2012 – July 2013

Nurse Consultant

As part of the medical call center team, provided clinical and technical support to end users in a, for all products within the divisions of IV Therapy, Vascular Access Devices, Pain Control, and Pharmacy Admixture.

Literature research for marketing initiatives

Developed and reviewed standard medical response documents.

Created, in collaboration with regulatory professionals, medical response documents to respond to inquiries from healthcare professionals and other end users of devices.

Collaborated with sales and marketing team for promotion and use of medical devices.

Provided medical and scientific review of materials used for advertising and promoting products within noted divisions

Assessed and trained new staff in departmental operations and SOPS.

Lehigh Valley Health Network – Allentown, PA September 2007 – February 2012

Patient Care Coordinator

Oversee administrative and operational issues for the care delivery team on the inpatient pediatric unit

Assisted the director with the management of material, financial and human resource responsibilities.

Coaching, counseling, mentoring, and scheduling of 72 direct reports.

Development and implementation of policies/procedures to improve care practices and patient outcomes. Assess, plan, implement and evaluate care for designated patients.

Connecticut Children’s Medical Center – Hartford, CT December 2004 – July 2007

Inpatient Staff Nurse –Oncology

Schneider’s Children’s Hospital - Manhasset, NY June 2002 – May 2004

Nurse Clinician/CRA, Outpatient Hematology/Oncology

Columbia University, New York, NY January 2001 – June 2002

Clinical Research Nurse, Pediatric Blood and Marrow Transplantation

Winthrop University Hospital, Mineola, NY January 2000 – December 2000

Staff Nurse, Pediatric Unit

Monmouth Medical Center, Long Branch, NJ May 1996 – December 1999

Patient Care Manager/CRA

Valerie Fund Children’s Center for Cancer and Blood Disorders

Newark Beth Israel Medical Center, Newark, NJ May 1991 – May 1996

Staff Nurse, Pediatric Unit

CERTIFICATIONS AND TRAINING

•Certified Clinical Research Coordinator (ACRP)

•Basic Life Support Provider – (AHA)

•Protection of Human Subjects in Research (CITI)

•GCP for Clinical Trials Involving Drugs, (CITI)

•GCP for Clinical Trials Involving Devices, (CITI)

•Protecting Human Research Participants, (CTEP)

•Certified Pediatric Oncology Nurse (APHON) Association of Pediatric Hematology Oncology Nurses

•Instructor -Chemotherapy/Biotherapy Provider Course (APHON)

•Pediatric Palliative Care-Train the Trainer, ELNEC

•Rater - NIHSS, (National Stroke Foundation)

•Rater – Modified Rankin Scale, (University of Glasgow)

•Rater - C-SSRS (Columbia Suicide Severity Rating Scale), (Columbia University)

•Rater – BDI-II, FSS, MMSE, Scopa-PC, QUIP-RS, Hauser PD Diary, UPDRS Part I, PHQ-9, PDQ-39, NPI, RUD, EQ5-D, RBANS, ADAS-Cog.

POSTERS

“Success with compassion: Peripheral intravenous cannulation in the pediatric November 2011

Population”.

Presented at: The Children’s Hospital of Philadelphia Annual Conference,

Philadelphia, PA.

“Coping with the loss of our child – a comprehensive guide for families.” October 2010

Presented at: The Association of Pediatric Hematology/Oncology Nurses (APHON)

34th Annual Conference and Exhibit, Minneapolis, MN.

PUBLICATIONS

Osunkwo, L., Cooney, E., Bessmertny, O., DiNatale, J., Garvin, J., Cairo, MS. 244Liposomal amphotericin B (AMB) prophylaxis is safe and effective in preventing invasive fungal infections (IFI) in related and unrelated allogeneic stem cell transplantation (ASCT). Biology of Blood and Marrow Transplantation (Impact Factor: 3.35). 02/2003; 9(2):134-134. DOI: 10.1016/S1083-8791(03)80229-X

LICENSURE

Pennsylvania #RN – 586805

New Jersey #26NO10061700 - inactive

COMPUTER PROFICIENCY

•Proficient in MS Office applications, including Word, Excel, Outlook, and PowerPoint

•Electronic Data Capture (EDC) and IWRS/IVRS Software such as Medidata-Rave, Inform/Oracle platforms, ICON, Perceptives MyTrials, Datalabs, etc.

SKILLS

•

•Excellent interpersonal and decision making skills

•Extensive and comprehensive knowledge of ICH guidelines/ GCP

•Demonstrated simultaneous management of multiple complex clinical projects

•Understanding of the tasks involved in a clinical development program

•Demonstrated ability to comprehend complex scientific concepts and data

•Proficient in reviewing and assessing clinical data

•Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements

Contact this candidate