Objective

Seeking position as Senior Clinical Safety Specialist using my experience working as a registered nurse, certified clinical research coordinator, clinical research specialist, and clinical safety specialist.

Professional Experience

Novella Clinical

Morrisville, NC

Apr. 2015- Present

Sr. Clinical Safety Specialist

Performs safety case processing tasks including, but not limited to:

Intake and triage tasks as performed by Clinical Safety Associate and/or Senior Clinical Safety Associate

Reviewing incoming safety information for completeness and accuracy

Tracking and data entry

Writing clinical narratives

Generating queries

Contacting sites for missing and/or unclear information

QC of cases

Generating regulatory reports

Reconciliation

Generating metrics

Serve as Safety Management lead on moderate to large sized studies/programs that are moderate to complex in scope of work with minimal guidance. Responsibilities include, but are not limited to:

All aspects of Safety Management start-up process including writing Safety Management Plan, developing SAE form, etc.

Attendance at team and client meetings

Investigator's meeting attendance

Presentations

Training of staff on safety processes

Compliance with budget, including estimating monthly budget projections

Ensures compliance with client budget and proactively escalates potential scope changes or noncompliance with cost or time allocation to department Manager

May assist with bid defenses or other presentations

May mentor and/or train new Safety Management staff

Performs other related duties as assigned or requested by department management

Medtronic

Memphis, TN

Apr. 2013- Apr. 2015

Sr. Clinical Research Safety Specialist

Assisted with developing, planning, and implementing the overall direction of clinical research projects in accordance with good scientific principles and pertinent government regulations

Prepared clinical safety documents for assigned clinical studies consistent with applicable policies and regulations

Assisted with the safety reporting for one or more concurrent clinical studies

Assisted in developing Safety Trial Operations infrastructure such as drafting and/or reviewing of Clinical Safety Plans and Clinical Safety Reports

Maintained clinical cancer registry

Assists with training of new team members

Clinical Research Safety Specialist (Sep. 2012- Apr. 2013)

Assisted with developing, planning, and implementing the overall direction of clinical research projects in accordance with good scientific principles and pertinent government regulations

Prepared clinical safety documents for assigned clinical studies consistent with applicable policies and regulations

Assisted with the safety reporting for one or more concurrent clinical studies

Evaluated clinical data/information, providing interim and final reports for assigned clinical study

Baptist Memorial Hospital

Memphis, TN

Nov. 2011- Sep. 2012

Certified Clinical Research Coordinator

Recruited, screened, and enrolled subjects for clinical trials in accordance with the approved protocol, protocol amendments, the FDA Code of Federal Regulations and ICH GCP guidelines

Coordinated phase II, III, and IV pharmaceutical clinical trials

Coordinated device trial

Medtronic

Memphis, TN

Mar. 2006- Nov. 2011

Clinical Research Specialist/Clinical Research Safety Specialist

Assists with developing, planning, and implementing the overall direction of clinical research projects in accordance with good scientific principles and pertinent government regulations

Provided strong contributions as key member of the A Team Motion Technology team

Assigned to 16 study sites and 2 field clinical research monitors

Worked with the Clinical Safety Manager to manage safety surveillance in compliance with applicable regulatory standards and Medtronic internal requirements

Assisted with reviewing and triaging clinical trial serious adverse events

Referred to Standard Operating Procedures and work instructions for guidance on everyday tasks

Presented safety information to Data Safety Monitoring Boards/Data Monitoring

Baptist Memorial Hospital- Memphis

Memphis, TN

Sep. 2005- Mar. 2006

Case Manager

Performed daily assessments of patients to determine if they met the criteria for the level of care that was appropriate for Medicare patients

Collaborated with physicians to transfer patients to the appropriate level of care

Assisted in developing safe discharge plans for Medicare patients

Utilized published guidelines to assess whether patients on a telemetry unit met criteria for level of care they were receiving as well as provided DRG codes

Collaborated with various resources to devise timely, safe discharge plans for patients

Certified Clinical Research Coordinator (Nov. 2001- Sep. 2005)

Recruited, screened, and enrolled subjects for clinical trials in accordance with the approved protocol, protocol amendments, the FDA Code of Federal Regulations and ICH GCP guidelines

Coordinated phase II, III, and IV pharmaceutical clinical trials as well as device trials

Coordinated up to 6 trials concurrently

Obtained certification (CCRC), through ACRP, in 2004

Registered Nurse in Cardiac Catheterization Laboratory/Electrophysiology Laboratory (1991- 2001)

Provided quality nursing care to patients undergoing diagnostic and interventional procedures in both the cardiac catheterization laboratory and the electrophysiology laboratory

Assessed vital signs, administered sedation and assessed response, held pressure until adequate hemostasis obtained, circulated, scrubbed, and provided education to patient and novice staff

Spearheaded the opening of the first electrophysiology laboratory at the East branch

Registered Nurse in Cardiac Critical Care Unit (1985- 1991)

Provided complete nursing care to patients stricken with acute cardiac-related illnesses in an intensive care unit setting

Delivered complete nursing care to patients with acute cardiac events, such as myocardial infarctions and decompensated heart failure

Functioned as a preceptor to novice nurses

Pharmacy Technician (1984- 1985)

Assisted the pharmacist with distributing prescribed medications to in-house patients

Accurately hand-picked patient medications from a list that was generated by a pharmacist

Delivered medications to appropriate unit in a timely manner

Mixed tube feedings as instructed

Nursing Assistant (1983- 1984)

Assisted with care of hospitalized patients under the direct supervision of the staff nurse (RN or LPN)

Monitored patients’ fluid intake and output, turned patients to prevent bed sores, assisted patients with activities of daily living (personal hygiene, sitting up in chair, going to the bathroom, etc.)

Performed minor procedures such as insertion of urinary catheters, soap suds enemas, and preoperative shave preps

Education

University of Phoenix

Bachelor of Science in Health Administration, 2012

Baptist School of Nursing, Memphis, TN

Diploma in Nursing, 1984

Licenses & Certifications

Registered Nurse (RN), State of Tennessee

License No. RN0000065956

ACRP (initial certification date 18-Sep-2004)

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