Pamela Simmons

Work History

Homemaker

Myself

01.2011 - Current

Addressed household needs with meal preparation, housekeeping and transportation.
Completed dusting, washing dishes, laundry,mopping and vacuuming
Maintained entire family's schedule and organized events.
Handled incoming mail, bills and invoices and completed appropriate actions.
Budgeted and performed all shopping tasks
Oversaw and designed complete master bathroom, kitchen. and master bedroom remodeling including kept all projects on or under budget

Regional Clinical Research Associate

RPS

04.2002 - 06.2023

Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
Followed drug storage procedures to comply with protocols and SOP requirements.
Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
Conducted clinical trial in accordance with protocol and recorded and monitored progress.
Oversaw project developments to provide quality deliverables while maintaining optimal efficiency.
Submitted routine monitoring reports and follow-up letters to facilitate internal and external communication.
Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
Facilitated quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency.
Liaised with clinical project leader to effectively resolve study-related issues.
Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
Conducted meetings with sponsor representatives to discuss clinical study developments.
Promoted awareness of project-specific quality and performance standards to support documentation, communication and understanding.
Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials.
Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
Gathered and organized clinical trial documentation to meet rigorous standards for site approval.
Provided clinicians with data to conduct clinical trials and determine methods to prevent, screen for, diagnose and treat disease.
Set up and disbanded trial study centers to manage clinical study activities for numerous sites.

Senior Clinical Research Associate

Novella Clinical

03.2009 - 09.2009

Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
Secured funding through proposal development and direct selling and supported strong business case for funded efforts.
Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
Designed and executed studies to support usability of solutions, analyze data and provide actionable recommendations to project team.
Managed project risk by identifying, quantifying and monitoring potential threats.
Followed drug storage procedures to comply with protocols and SOP requirements.
Communicated project status to management verbally and through technical documentation and presentations.
Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
Collected data and followed research protocols, operations manuals, and case report form requirements.
Maintained compliance with protocols covering patient care and clinical trial operations.
Followed informed consent processes and maintained records.
Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.

Eli Lilly for Medfocus

Clinical Research Associate-Contractor

01.2008 - 01.2009

Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
Designed and executed studies to support usability of solutions, analyze data and provide actionable recommendations to project team.
Managed project risk by identifying, quantifying and monitoring potential threats.
Achieved project objectives by troubleshooting experiments and testing practical and creative solutions.
Followed drug storage procedures to comply with protocols and SOP requirements.
Directed, guided and delegated tasks to teams and developed project schedules, resource requirements and timelines to maintain productivity on goals and objectives.
Communicated project status to management verbally and through technical documentation and presentations.
Conducted independent research to validate efficacy of solutions, assimilate results and prepare written technical reports.
Synthesized and utilized key information from proposals, technical reports and publications to achieve objectives.
Maintained knowledge of company strategic direction, goals and objectives and aligned projects appropriately.
Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
Collected data and followed research protocols, operations manuals, and case report form requirements.
Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
Maintained compliance with protocols covering patient care and clinical trial operations.
Followed informed consent processes and maintained records.
Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.

Project Manager

Pharm-Olam Research

06.2007 - 03.2008

Planned, designed, and scheduled phases for large projects.
Monitored project performance to identify areas of improvement and make adjustments.
Coordinated with cross-functional teams to resolve project issues and mitigate risks.
Achieved project deadlines by coordinating with contractors to manage performance.
Identified plans and resources required to meet project goals and objectives.
Developed and initiated projects, managed costs, and monitored performance.
Prepared and submitted project invoices for review and approval.
Negotiated and managed third-party contracts related to project deliverables.
Drafted project reports to identify successful outcomes, insights and future recommendations.
Monitored project progress, identified risks and took corrective action as needed.
Maintained open communication by presenting regular updates on project status to customers.
Tracked project and team member performance closely to quickly intervene in mistakes or delays.
Reported regularly to managers on project budget, progress and technical problems.
Developed and implemented project plans and budgets to ensure successful execution.
Verified quality of deliverables and conformance to specifications before submitting to clients.

Lead Clinical Research

PRA International

09.2006 - 04.2007

Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
Followed informed consent processes and maintained records.
Collected data and followed research protocols, operations manuals, and case report form requirements.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Maintained compliance with protocols covering patient care and clinical trial operations.
Collected, evaluated, and modeled collected data.
Skilled at working independently and collaboratively in a team environment.
Self-motivated, with a strong sense of personal responsibility.
Worked well in a team setting, providing support and guidance.
Proven ability to learn quickly and adapt to new situations.
Worked effectively in fast-paced environments.
Managed time efficiently in order to complete all tasks within deadlines.
Demonstrated respect, friendliness and willingness to help wherever needed.
Excellent communication skills, both verbal and written.
Passionate about learning and committed to continual improvement.
Strengthened communication skills through regular interactions with others.

Regional Senior Clinical Research Associate

PPD Development

11.2003 - 09.2006

Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
Secured funding through proposal development and direct selling and supported strong business case for funded efforts.
Managed project risk by identifying, quantifying and monitoring potential threats.
Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
Maintained knowledge of company strategic direction, goals and objectives and aligned projects appropriately.
Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
Collected data and followed research protocols, operations manuals, and case report form requirements.
Maintained compliance with protocols covering patient care and clinical trial operations.
Followed informed consent processes and maintained records.

Regional Senior Clinical Research Associate

Schering Plough Pharmaceuticals

11.1999 - 01.2002

Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
Managed project risk by identifying, quantifying and monitoring potential threats.
Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
Followed drug storage procedures to comply with protocols and SOP requirements.
Synthesized and utilized key information from proposals, technical reports and publications to achieve objectives.
Maintained knowledge of company strategic direction, goals and objectives and aligned projects appropriately.
Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
Collected data and followed research protocols, operations manuals, and case report form requirements.
Maintained compliance with protocols covering patient care and clinical trial operations.
Followed informed consent processes and maintained records.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.

Regional Senior Clinical Research Associate

Omnicare Formerly IBAH

07.1998 - 11.1999

Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
Managed project risk by identifying, quantifying and monitoring potential threats.
Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
Followed drug storage procedures to comply with protocols and SOP requirements.
Maintained knowledge of company strategic direction, goals and objectives and aligned projects appropriately.
Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
Collected data and followed research protocols, operations manuals, and case report form requirements.
Maintained compliance with protocols covering patient care and clinical trial operations.
Followed informed consent processes and maintained records.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.

Senior Lead Clinical Research Associate

ClinTrials Research

09.1996 - 07.1998

Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
Managed project risk by identifying, quantifying and monitoring potential threats.
Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
Followed drug storage procedures to comply with protocols and SOP requirements.
Directed, guided and delegated tasks to teams and developed project schedules, resource requirements and timelines to maintain productivity on goals and objectives.
Maintained knowledge of company strategic direction, goals and objectives and aligned projects appropriately.
Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
Collected data and followed research protocols, operations manuals, and case report form requirements.
Maintained compliance with protocols covering patient care and clinical trial operations.
Followed informed consent processes and maintained records.
Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.

Project Manager

Covance Clinical Research

08.1989 - 09.1996

Planned, designed, and scheduled phases for large projects.
Monitored project performance to identify areas of improvement and make adjustments.
Coordinated with cross-functional teams to resolve project issues and mitigate risks.
Achieved project deadlines by coordinating with contractors to manage performance.
Collected data and followed research protocols, operations manuals, and case report form requirements.
Followed informed consent processes and maintained records.
Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
Maintained compliance with protocols covering patient care and clinical trial operations.
Monitored unit budget to meet financial objectives for spend rate and funding.
Skilled at working independently and collaboratively in a team environment.
Self-motivated, with a strong sense of personal responsibility.
Proven ability to learn quickly and adapt to new situations.
Worked well in a team setting, providing support and guidance.
Worked effectively in fast-paced environments.
Managed time efficiently in order to complete all tasks within deadlines.
Excellent communication skills, both verbal and written.
Demonstrated respect, friendliness and willingness to help wherever needed.
Passionate about learning and committed to continual improvement.

Registered Respiratory Therapist

Vanderbilt University Medical Center

06.1987 - 08.1989

Managed and operated mechanical ventilators to deliver airway management.
Aided physicians with various procedures such as bronchoscopies, ventilator management, and intubations.
Evaluated patient response to respiratory treatments and revised care plans accordingly.
Worked with patients to administer aerosolized respiratory medications and chest percussion treatments to improve breathing.
Coordinated with physicians and other care team members on care and treatments.
Monitored patient's physiological responses to therapy such as vital signs, arterial blood gases, and blood chemistry changes.
Verified proper set-up of ventilators for both adult and pediatric patients.
Delivered treatment for patients experiencing chronic and acute respiratory illnesses by conducting assessments and providing diagnoses.
Assessed, diagnosed, and treated breathing issues.
Maintained proper oxygen titration levels of patients receiving ventilator support.
Provided antibiotics, bronchodilators, and anti-inflammatory medications with hand-held nebulizers, metered-dose inhalers and positive pressure equipment.
Consistently responded within time limits to requests for respiratory assessments.
Administered oxygen therapy, aerosol therapy and inhalation therapy to improve patients' breathing and lung function.
Performed bronchial hygiene techniques to remove mucus and secretions from patient lungs and improve lung function.
Educated patients and families on proper use of respiratory equipment and techniques for managing respiratory disorders to improve patient outcomes.
Completed continued education units annually to stay current with respiratory therapy advancements and maintain compliance with administrative regulations.

Summary

Overview

Work History

Homemaker

Regional Clinical Research Associate

Senior Clinical Research Associate

Eli Lilly for Medfocus

Project Manager

Lead Clinical Research

Regional Senior Clinical Research Associate

Regional Senior Clinical Research Associate

Regional Senior Clinical Research Associate

Senior Lead Clinical Research Associate

Project Manager

Registered Respiratory Therapist

Education

Bachelor of Arts - Management And Human Relations

Associate of Science - Respiratory Care

Skills

Certification

Languages

Additional Information

Accomplishments

Quality Quest and Project Manager of the Year Award 1998

Timeline

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