Jill M Dahlsten

** *** **** *****

Juno Beach, Florida 33408

+816-***-****

ad4wws@r.postjobfree.com

April 2021-present: Medical Leave

Date: Nov 2020-March 2021

Company: ExecuPharm

Job Title: Site Relationship and Excellence Partner (SREP)

• Main point of contact for investigative sites as well as accountable for safeguarding the quality and patient safety as well as liaising and escalating issues as needed for resolution

• Responsible for monitoring oversight and building and retaining relationships from site activation through the lifecycle of the study

• Accountable for identifying Clinical Research Associate (CRA) performance issues annd is responsible for ensuring appropriate corrective active plan is put in place

• Proactively collaborate and provide local intelligence to country outreach surveys, target site strategies, study design, and Client pipeline opportunities

• Maintain regular communication with investigators and sites to client reputation ather status updates, informal and formal performance metrics and study level feedback

• Demonstrate leadership within the local clinical development environment with a goal to enhance Client reputation in scientific relationship

• Responsible for site monitoring and quality, Regulatory and Good Clinical Practice

(GCP) compliance

• Drive inspection readiness and provide and provide site readiness and provide site support for site audits/inspections as needed, following through audit/inspection findings through resolution

• Conduct and report oversight activities, both remote and onsite visits according to Client requirements and standards

• Maintain a thorough knowledge and understanding of assigned protocols, including associated risks and mitigations as it relates site and monitoring quality

• Attend Invester meetings/protocol trainings to ensure clear understanding of assigned protocol

Date: August 2020-November 2020

Company: Premier Research

Job Title: Senior Clinical Research Associate

• Deliver quality, timely monitoring reports for sponsor approval per Clinical Monitoring Plan (CMP) timelines

• Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as directed by ICH/GCP/ISO14155, protocol and client requirements

• Prepare for and conduct on-site qualification, study monitoring, and closeout visits at investigator site per the CMP

• Monitors remotely or onsite or other approved method with a focus on data integrity and patient safety in accordance to specific country regulations

• Monitors with knowledge quality/scope/timeline and budget parameters

• Maintains Trial Master File (TMF) as defined by the organization's processes per fiiling guidelines. Has and understanding of of the required essential documents according to ICH/GCP Section Eight. Reviews site documents and verifies they are accurate, complete, and current and include required updates.

• Maintains project tracking system of subjects and site information as applicable.

• Maintains communication with study sites as directed with assigned study sites as directed per CMP, and in agreement with the study site and completes documentation of contacts

• Ensures site visit metrics and utilization are maintained as required and escalates available time to as necessary to the line manager

• Maintains high level of attention to detail to ensure subject safety for the project and delivery of quality for our clinics

• Reviews IP accountability and applicable subject and site level logs as directed per CMP and lead

• Completes all required internal training (general and study specific) on time

• Acts as a resource for other CRA’s and shares knowledge and based and best practices

• Other duties as assigned

• Often worked at sites with quality concerns and or questionable activities

• Assisted with report reviews

Date: April 2019-July 2020

Company: Syneos Health

Job Title: Clinical Research Associate II

• Assisted in the managing and execution of the clinical component of study protocols of high complexity within the US in accordance with the scope of work and contracted timelines

• Contributed to the risk and quality management process for assigned sites/studies to include audit prep and attendance

• Prepared and conducted site qualification, study initiation, interim monitoring visits, and closeout visits at investigative sites as required by the CMP

• Deliver quality, timely reports for sponsor approval per CMP

• Responsible for the validity, correctness, and completeness of the data reviewed and collected at assigned sites as dictated by ICH/GCP/ISO 14155, protocol and client requirements

• Maintained TMF file and etMF as defined by the organization’s process per guidelines. Has an understanding of the required essential documents and verified they were accurate, complete, and current and include required updates

• Maintained project tracking systems of subjects and site information as applicable Date: Sep 2013-March 2019

Company: IQVIA (Formally Quintiles)

Title: Clinical Reserarch Associate III

• Completed site monitoring responsibilities for Stage I-IV study protocols

• Act as a mentor for new staff

• Educated investigators and site staff on all aspects of the protocol as well as expectations of their conduct

• Attended and participated in all Investigator meetings as well as internal training

• Completed all required trainings in a timely manner for all assigned protocols

• Escalated any identified deviations/risks/site difficulties as needed to assigned Lead or Project Manager

• Completed all required all required Documation for per protocol SOP’s within the given timeline

• Discussed with site staff as needed with site staff as needed between onsite visits any issues and or needs

• Completed and followed Corrective action plans as needed for any quality issues identified during both onsite and offsite visits

• Completed other activities as assigned

• Often assigned to sites that had quality concerns and or questionable activities Date: June 2012-Sep 2013

Company: Children’s Mercy Hospital

Job Title: Clinical Research Operation Manager

• Functioned as Clinical Research Coordination Liaison with Pharmaceutical Vendors interested in conducting research with Children’s Research Hospital and Clinics

• Assisted and functioned as needed as a Clinical Trial Coordinator to conduct IRB approved studies

• Completed internal audits and review of all Experimental Pediatric Oncology studies to verify compliance and valid data

• Prepared and assisted in preparing for sponsor audit which had no major or critical findings

• Assisted in training of research coordinators, fellows, and staff new to research as needed and or requested

• Responsible for managerial and admistrative tasks to include but is not limited to contract completion, creation of study tools/documents, assistance with building of EDC data capture design platform for a Pediatric Arthritis Study

• Attended a US based Research based forum to represent our facility to other Vendors

• Acted as a mentor for new staff

• Completed report reviews as needed

Date: Jun 2012-Jun 2013

Company: Children’s Mercy Hospiital

Job Title: Clinical Research Nurse Coordinator II

• Functioned as Clinical Trial Manager and Coordinator in IRB approved NIH funded study

• Completed internal audit for Experimental Pediatric Oncology department

• Assisted Investigators throughout the hospital with clinical research trials Primary duties included but are not limited to budget creation, protocol assessment, assisted with study initiation, submission of all IRB required documents and reports, proper conduct of study trial per ICH/GCP guidelines, and ensuring all monitoring visits are completed per CMP

• Mentored and supervised new coordinators

• Created and conducted training of required hospital staff as needed Date: Jan 2011—Jun 2012

Company: Quintiles

Job Title: Clinical Research Lead Research Specialist

• Functioned as a Clinical Lead Research Search Specialist on a large-scale Stage IV trial

• Was over a total of 18 CRA’s for immediate guidance

• Trained all incoming CRA’s on the protocol and expectations

• Functioned as the Quality Lead for all US sites as reported by CRA’s either remotely or traveling to the site with the CRA. Communicated all issues to other Leads as nd the Project Manager

• Completed CAPA plans as needed for sites as needed and provided quality support as needed for any required sites and assisted the CRA in assuring all requests are completed to resolution

• Presented at International Investigator meeting

• Backed up other leads as needed

• Attended client face to face meetings as needed

• Worked closely with Project Manager

• Completed all required training

• Traveled internationally as requested to assist in prepping in an FDA audit

• Completed report review of assigned CRA’s

Date: Oct2007-Mar2014

Company: Medivance (later sold to Bard)

Job Title: PRN On-call Nurse Device Specialist

• On-call specialist providing remote technical assistance, troubleshooting, and clinical education for medical device

• Appropriate and timely documentation of all incoming calls to include escalation to the Territory Sales Manager and Full Time Clinical Specialness with escalation of potential new sites interested in the device to Territory Sales Managers

• Preparation and distribution of needed clinical education tools to assist staff internal training as needed

Date: June 2007-Jan 2011

Company: Quintiles

Job Title: Clinical Team Lead

• Functioned as a Clinical lead managing 18 CRA’s dispersed throughout the US and Canada. Provided training and guidance as needed and escalation management to the Sponsor with site issues as needed

• Perso management via conversations with the CRA’s and their Line Manager’s to adequately control their duties and assignments as well as ensure appropriate training was available and completed in a timely manner both internally as well as by the sponsor

• Conducted remote and onsite visits of sites demonstrating quality issues to create a CAPA plan as needed

• Provided remote and onsite assistance to resolve all issues noted on the CAPA as needed

• Completed employee performance reviews

• Provided coverage for other peer Leads as needed

• Completed FDA audit preparation for three weeks overseas with a peer group of 12 international staff

• Provided management support for sites demonstrating non-compliance for a 20,000- patient long term world-wide study as the Quality Liaison

• Worked as on-site Quality Specialist for sites proving to be resistant to CRA recommendations and demonstrating protocol/ICH/GCP/FDA non-compliance in the US and Canada

• Provided mentoring to staff and Investigators regarding the protocol and GCP

• Presented as needed at IM meetings

• Act as a mentor to any CRA on the study in the US on-site to assist in any concerns or challenges

Date: Aug 2006-June 2007

Company: Quintiles

Job Title: CRA II

• Assisted in managing the execution of the clinical component of study protocols of high complexity within the US as well as internationally in accordance with the scope of work and contracted timelines

• Functioned as a Clinical Team Lead with the attainment of clinical deliverables within the study timelines and budget by setting up clinical tools and processes for the study team as needed while also functioning as a CRA

• Development and presentation of CRA training

• Presented at Investigator meeting per Sponsor request

• Requested and assigned to sites that have been noted to have issues with quality or to be research naïve

• Contributed to the risk and quality management process for assigned sites/studies to include but limited to audit prep attendance

• Prepared and conducted site site qualifiication, study initication, interim monitoring site close out visits, and closeout visits as required per CMP

• Delivered quality, timely trip reports for team and Sponsor reports

• Responsible for validity, correctness and completeness of the data reviewed and collected at site visits as directed ICH/GCP/ISO14155 protocol and Sponsor request

• Maintained TMF and eTMF as defined by the organization and Sponsor requirements. Maintained an understanding of required essential documents according to ICH/GCP Section 8. Reviewed site documents and verified they were accurate, complete, current and included required all needed updates

• Maintained all project and tracking systems of sites and subjects per protocol

• Reviewed IP accountability and applicable logs (subject and site level)

• Completed all trainings in a timely manner

• Acted as a resource and mentor for new staff joining the team to protocol

• Completed all trainings (internal and external) in a timely fashion

• Acted as a resource and mentor for other CRAs

• Other activities as assigned

Date: Oct 2004-Aug 2006

Company: Medivance

Job Title: Clinical Education Specialist/Clinical Research Specialist

• Developed and maintained research protocols with associated education tools and prestation tools as needed

• Development and presentation of device and research studies to site staff in the US and Canada

• Presenter at Investigator Meetings

• Contributed to the risk and quality management process management for assigned sites/studies to include audit preparation and attendance

• Prepared and conducted site qualification, site initiation, regular monitor visits, site closure per CMP

• Delivered quality and timely reports for all site visits

• Responsible for review of the validity, correctness and completeness of the clinical data reviewed and collected at assigned sited during visits as directed by ICH/GCP Section guidelines and protocol requirements

• Maintained all subject and site level tracking systems per protocol

• Completed all internal and external trainings within required timelines

• Acted as a mentor for and resource for other staff and shared knowledge base and best practices as well as protocol training as needed

• Assisted in the development of hypothermic device design and configuration for best results

• Assisted in the creation of the “train the trainer”and of and development of the tools for sites to use for success

• Management of a Canadian based pilot program pilot study for a new hypothermic mobile device and configuration of the device for best results. This included onsite training, monitoring and remote communication with the engineers to reconfigure the device as needed

• Other activities as designated

Date: Oct 2001-Oct 2004

Company: St. Luke’s Hospital

Title: Cardiac Research RN Coordination

• Duties include all aspects of clinical management including but not limited to investigational study selection, budgeting, and approval/project negations and Regulatory Documation as needed. IRB submission as required. Completion on of required site screening, site inanition, monitoring, close out visits per CMP

• Completion of staff in servicing and training of peers as needed. Participation in all monitor visits

• Completion of staff training and mentoring as needed to ensure protocol compliance

• Conduct data documentation and ensured compliance

• Followed up for all research protocols assigned to ensure compliance

• Follow up for all protocols to ensure payment for study activities and return IP and or devices as needed

• Oversaw and managed all research projects assigned with manager escalation as needed

• Created a RN Research Training Manual

• Prepare and presented study status reports for Manager and VP of Heart Institute

• Presented at various Meetings

Date: Oct 2000-O2001

Company: Cardiovascular Consultants

Job Title: Physician RN and Stress Tess Testing

• Employee Performance reviews

• Hospital Rounds with Physicians

• Patient Stress testing both with treadmill and use of Dopimine

• Attend patient visits with physician

• Return patient results via phone with phone post physician review

• Protime and Lipid Clinics

• Assisted in implantable device testing

Date: Oct 1999-Oct 2000

Company: St. Luke’s Hospital

Job Title: Cath Lab and EP Lab RN

• Served as circulating RN and Scrub RN assistant in Cardiac Cath Lab and EP Labs completing diagnostic and interventional cases

• Worked as a mentor to newly onboarded staff

• Assigned to focus on research casers in both the Cath Lab and Cardiac EP Labs

• Responsible for on-call hours per lab scheduling for cases occurring outside of normal operating hours

• Assisted in inventory review

Date: Apr 1998-Oct 1999

Company: St. Luke’s Hospital

Job Title :RN/CTN

• Worked in Cardiac ICU caring for patients immediately after Cardiac or Thoracic surgery

• Worked with Transplant patients immediately post-transplant and was with the transplant team harvesting the heart and or lungs from outside facilities

• Cross-trained RN’s to work in ICU and step-down units

• Worked as a charge RN in the Cardiac step-down units

• Preceptor for new staff

• Designed and developed training manual for step down unit

• Designated as CTN representative, sitting in on committee meetings for scheduling, delegation, education, training, task force and rewords and recognitions

• Certified instructor for Basic Life Saving and Diabetic testing

• Assisted in covering in the Emergency department as needed Date: Jan 1998-Apr1988

Company: Research Medical Center

Job Title: RN

• Worked in Critical Care ICU, Neuro ICU, Cardiac ICU, Emergency until Nursing Boards were finalized

Date: Feb 1996-Oct 1996

Company: Centennial Life Insurance

Job Title: Customer Service for Medical Claims Department

• Reviewed and processed medical claims for medical insurance coverage

• Escalated concerning medical claims to management, as needed, per company policy

• Worked closely with claimants to resolve and any issues claims, and any issues associated with them with them

• Trained and mentored new staff

Date: June 1993-1995

Company: Rehabilitation Center

Job Title: Work Hardening/Conditioning Supervisor

• Supervised and assisted in the rehabilitation of workers injured on the job with the goa to9 return to work at the highest physical functioning level based on physician and physical therapy assement guidance

• Completed education of appropriate ergometric guidance and physical movement

• Certified in Water Rehabilitation Specialist to allow increased strength in patients post back, shoulder, knee, surgery

• Participated depositions and court appearances as needed to discuss patient abilities and outcomes

• Created personalized patient daily workouts based on their abilities and created rea work activities for patients to mimic each day to day to meet job requirements

• Testing of subjects for maximal and safe strength abilities Therapeutic Experience:

• Pilot- Congestive Heart Failure Device

• Pilot- Pivitol Arrythmias Devices

• Pivitol Atrial Ablation for Atrial Fibrillation deices

• Pilot Hypothermia in Cardiac Arrest Patients Study

• Pilot Hypothermia treatment for subjects post Stroke Study Pivitol Arterial Disease Device

• Pivitol Cardiovasculature Disease Device

• Pivitol Arterial Closure Device Post Cardiac Catheterization

• Pivitol Mitral Valve Device

• Pilot Stroke Device

• Pilot Hypertension device

Endocrine Disorders

• Phase III Type I and Type II

Hematology US and Global

• Phase II Antiphoslific Disease

• Phase III Sickle Cell

Neurology: US and Canada

• Pilot: Traumatic Brain Injury

• Phase III: Multiple Sclerosis

Oncology US

• Phase I, II Solid Tumors

• Phase II and III Lukemia

Pulmonary US

• Pediatric Cystic Fibrosis

• Phase III Asthma

Vaccine Studies

Phase I

Public Speaking at Investigator meetings and Public Medica Forums Education:

Year 1997

BSN, Research School of Nursing

Accelerated Program

Kansas City, Missouri

Year: 1992

BS, Exercise Science University of Kanases

Lawarence, Kansas

Languages:

English

Professional Affinizations

ACRP Certified and an active member

Ms. Dahlsten began her career working in Exercise Rehabilitation to workers injured on the job. Specifically ran theWork Hardening and Conditioning Program. This included being sent on a training course in water Rehab and then using this form of rehabilitation for Subjects as needed. However, the facility, Rehab Facility, decided to remove all Exercise Science staff and replace them with Occupational and Physical Staff Assistants due to multiple Legal cases we would be deposed for.

Following this, Ms. Dahlsten chose to return to school for an Accelerated Nursing Degree with a goal to focus work once Certified in the Cardiac ICU’s and Emergency Departments. As noted above, Ms. Dahlsten later entered into the Research world and functioned as a CRA

(various levels), Clinical Lead, Quality Lead, Mentor and educator for New Staff, assisted in completion of an Overseas three-week FDA Audit preparation, Completed Speaking and Presentations as requested at meetings, and Staff Trainings, functioned as a Trip Report Reviewer, functioned as a Clinical Device Specialist, as well as functioned as a Clinical Educator.

Ms. Dahlsten has been Certified with ACRP as a CCRC since 2004 and this is currently active. Ms. Dahlsten held an RN License from 1998-2015, and a RN License in Florid from 2015-2022. It was placed on hold as it was not required for the present job. However, it can be reinstated upon completion of Clinical Education trainings.

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