Lynda Ahearn, Rn

Lynda Ahearn, Rn Email and Phone Number

Retired @ None
Lynda Ahearn, Rn's Location
Hockessin, Delaware, United States, United States
Lynda Ahearn, Rn's Contact Details

Lynda Ahearn, Rn personal email

n/a

Lynda Ahearn, Rn phone numbers

About Lynda Ahearn, Rn

Eighteen years of experience in clinical research, combined with extensive experience as a Registered Nurse functioning in direct patient care, patient recruitment, and patient advocacy capacities. Broad-based clinical exposure, including direct patient care or research-based experience in neurosciences, oncology, renal, orthopedic, student health, emergency/trauma nursing, and medical/surgical areas. Extensive site management and data management experience with global clinical trials in all phases, including late phase research. Proven ability to combine medical expertise with research experience to ensure the delivery of quality, valid study data. Adept at interfacing with vendor representatives, programmers, biostatisticians, principal investigators, and on-site personnel at all levels to ensure successful patient enrollment, study execution, and data submission. Demonstrates initiative, intuitive problem-solving abilities, well-honed communication skills, and strengths in managing multiple priorities and visualizing short- and long-term goals. Skillful in the management of external vendors and internal stakeholders to foster a collaborative team spirit, resulting in the consistent achievement of complex project goals within strict time and budget constraints.

Lynda Ahearn, Rn's Current Company Details
None

None

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Retired
Lynda Ahearn, Rn Work Experience Details
  • None
    Retired
    None May 2024 - Present
  • Incyte
    Clinical Operations Lead
    Incyte Apr 2011
    Wilmington, Delaware, Us
    Assist in the development and writing of clinical trial documents and manuals, including Case Report Forms, informed consent forms and other regulatory documents. Participate in the evaluation and selection of investigative sites. Coordinate and monitor activities at investigational sites; review monitoring trip reports and conduct co-monitoring visits. Establish study priorities. Participate in data review and discrepancy resolution. Monitor study safety. Ensure study timelines are being met. Participate in clinical team meetings and trainings. Serve as a clinical liaison between the Clinical Drug Development Team and other departments.
  • Astrazeneca
    Study Delivery Operations Specialist
    Astrazeneca Jan 2006 - Apr 2011
    Cambridge, Cambridgeshire, Gb
    Coordinate various aspects of planning, execution, and control of clinical trials and research projects to ensure compliance with regulatory and ethical research standards. Support study process to ensure adherence to protocol and applicable SOPs, GCP/GEP/ICH Guidelines, regulatory requirements, and other documentation requirements. Manage site recruitment and qualification, site initiation and start-up, patient recruitment and retention, study material development, and electronic data collection and management. Oversee and process regulatory documents for study start-up, drug shipment and site maintenance. Function as Data Management Team Lead for one Neuroscience study and Site Manager for three neuroscience studies. Coordinate efforts of internal and external team members, vendors, and principal investigator sites on complex, Phase I through IV global clinical studies to ensure regulatory compliance and on-time completion of study deliverables. Create Feasibility Questionnaires, Case Report Forms, Data Management Plan, Data/DCF Flow, SAE Reconciliation Guidelines, Quality Control Plans, Data Coding Guidelines, and Data Validation Guidelines. Facilitate Case Report Form reconciliation process and execute monthly Serious Adverse Event reconciliation. Prepare annual Investigational New Drug (IND) updates.
  • The Children'S Hospital Of Philadelphia
    Senior Research Nurse Coordinator
    The Children'S Hospital Of Philadelphia Jan 2003 - Jun 2005
    Philadelphia, Pa, Us
    Coordinated multiple investigator and industry-sponsored clinical studies in cardiology, emergency medicine, and oncology including a 300-patient per year Pediatric Pharmacology Research Unit (PPRU) study for the National Institute of Health (NIH) and a global, multi-center, investigator-initiated cardiology research study for 2,616 patients. Monitored enrollment, randomization, and data collection at multiple sites to ensure ongoing compliance with GCP and ICH guidelines. Coordinated and conducted site initiation visits and investigator meetings at US and UK sites. Collaborated with PI and Biostatisticians on the development of Case Report Forms, questionnaires, and database formats. Formulated study protocol based on grant submissions, conducted site initiation meetings, oversaw study recruitment, performed budget reconciliation, and managed vendors. Supervised database production and evaluated data submissions for accuracy and validity. Issued queries and resolved discrepancies, and facilitated timely compilation of data tables for further evaluation. Hired, trained, and mentored multiple work-study students.
  • Bristol-Myers Squibb
    Clinical Event Coordinator
    Bristol-Myers Squibb Aug 2001 - Jan 2003
    Lawrence Township, Nj, Us
    Coordinated the Clinical Event dossier process and directed conferences with independent adjudicators for multiple Phase II and Phase III cardiovascular studies. Collaborated with Medical Monitors, Drug Safety Representatives, and Site Coordinators on the identification of Serious Adverse Events and organization of documentation. Oriented new study management personnel and monitors to the process of end point adjudication
  • Dupont Pharmaceuticals
    Clinical Events Coordinator
    Dupont Pharmaceuticals Jan 2001 - Aug 2001
    Us
    Coordinated the Clinical Event dossier process and directed conferences with independent adjudicators for multiple Phase II and Phase III cardiovascular studies. Collaborated with Medical Monitors, Drug Safety Representatives, and Site Coordinators on the identification of Serious Adverse Events and organization of documentation. Oriented new study management personnel and monitors to the process of end point adjudication
  • University Of Delaware
    Student Health Center Nurse
    University Of Delaware Jan 1999 - Jan 2001
    Newark, De, Us
    • Supervised the health center in the absence of physicians and administration.• Directed Licensed Practical Nurse activities for in-patient care.• Performed initial assessment of student’s health care and triaged to physicians as necessary.
  • Dupont Hospital For Children
    Staff Registered Nurse
    Dupont Hospital For Children Sep 1978 - Nov 1998
    •Emergency Services Staff Nurse, Rehabilitation Staff Nurse Rotated as charge nurse or triage nurse on a weekly basis.• Tabulated ER statistics for the medical administration to resolve staffing issues and improve patient care.• Committee Involvement: Emergency Services Leadership Committee, CQI Committee, Nursing Practice and Standards Committee, Hospital Quality Assurance Committee, and Statistics Committee.• Created patient care plans for 24-hour care to be implemented by nursing staff.• Coordinated health care and discharge planning with families and outside agencies• Supervised unlicensed staff.• Performed all aspects of med-surge nursing and peritoneal dialysis.

Lynda Ahearn, Rn Skills

Gcp Clinical Trials Ctms Clinical Development Clinical Research Pharmaceutical Industry Protocol Edc Cro Ich Gcp Therapeutic Areas Patient Recruitment Clinical Operations Drug Development Clinical Data Management Clinical Study Design Regulatory Affairs Sop Infectious Diseases Clinical Monitoring Fda Pharmacovigilance

Lynda Ahearn, Rn Education Details

  • Widener University
    Widener University
    Alph Sigma Lambda Honor Society
  • Nursing School Of Wilmington
    Nursing School Of Wilmington
    Registered Nurse

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What schools did Lynda Ahearn, Rn attend?

Lynda Ahearn, Rn attended Widener University, Nursing School Of Wilmington.

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Lynda Ahearn, Rn has skills like Gcp, Clinical Trials, Ctms, Clinical Development, Clinical Research, Pharmaceutical Industry, Protocol, Edc, Cro, Ich Gcp, Therapeutic Areas, Patient Recruitment.

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