Senior Clinical Research Associate - Organ Transplantation (East Coast) - United Therapeutics
Raleigh, NC
About the Job
California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .
The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.
How you’ll contribute
Serves as an expert in Clinical Monitoring activities and processes from study start-up of a clinical study through close-out. Work with monitoring team members and cross functional project team members to ensure efficient and effective conduct of clinical trials; responsible for field and off-site monitoring activities for oversight of a clinical trial to facilitate study enrollment; build effective site relationships; ensure that the rights and well-being of study subjects are protected, reported trial data are accurate, complete, and verifiable from source documents, and the conduct of the study is in compliance with the currently approved protocol, site/UTC Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.
Trial Support Activities:
+ Serve as the primary contact and site manager with advanced expertise for field monitoring activities to convey project information and address questions from study sites, study team members, and Third- Party Vendors (TPVs) on behalf of UTC
+ Attain a thorough understanding of site management tasks and responsibilities necessary to implement compliance with the protocol, applicable regulations/guidelines and UTC Standard Operating Procedures (SOPs)
+ Develop and maintain collaborative working relationships with study sites
+ Accountable for subject safety, data integrity and regulatory compliance for assigned sites
+ Monitor recruitment through study applicable systems (IXRS, EDC) and/or communication with site staff; track subject enrollment and participation at each trial site including executing and maintaining enrollment plans
+ Ensure regulatory documents are collected, reviewed, processed, and submitted to the electronic Trial Master File (eTMF) throughout the lifecycle of any assigned studies in collaboration with the assigned In-house CRA (iCRA) and study team, as applicable
+ Perform inspection readiness activities within the eTMF throughout the lifecycle of any assigned studies, including archiving procedures at the time of study termination
+ Maintain site information and communication reports within the UTC eTMF and other study tracking tools
+ Perform virtual/on-site monitoring visits (i.e. evaluation, initiation, interim and close-out) as required by the monitoring plan for assigned studies
+ Provide training to site staff as needed via onsite/remote (phone or teleconference/web meeting) on protocol, study/vendor technology, sponsor and regulatory requirements for study conduct
+ Work through complex site issues and collaborate with high level site staff with minimal supervision/escalation needed
+ Review the quality and integrity of clinical data via Source Document Review/Source Data Verification (SDR/SDV) to ensure assigned study sites' adherence to the protocol, eCRF completion guidelines and regulations
+ Responsible for issuance, review and closure of queries to address data discrepancies between source and clinical data reported in the study specified CRF (paper or electronic)
+ Drive the reporting, tracking, and management of site non-compliance (e.g. protocol deviations, GCP deviations and/or violations)
+ Provide advanced level support to the study team in preparation for audits/inspections; provide response for the quality and completeness of clinical trial documentation; may collaborate with the In-house CRA (iCRA), Monitoring Team Lead (MTL), Management or other study team members to ensure appropriate oversight of Corrective and Preventative Action (CAPA) with study sites
+ Monitor site performance and implement action plans for study sites not meeting expectations in conjunction with the assigned iCRA and study assigned MTL, as applicable
+ Create confirmation letters, monitoring visit reports and follow-up letters for each monitoring visit using either a clinical trial management system (CTMS) or study-specific process
+ Support Study Product (SP) activities at site level for assigned study(ies); inclusive of assessing supply, reviewing and providing input on IXRS and SP accountability / reconciliation at sites, tracking expiry dates and returning of SP
+ Regularly meet with Principal Investigators and site staff during remote/on-site visits for assigned sites to keep them apprised of issues/concerns affecting the study
+ May function as a Lead CRA; tasked with performing specific Monitoring Team Lead (MTL) duties, as necessary
+ Drive data cleaning efforts with Investigative Sites in preparation for study interim analysis and database lock
Meeting Attendance and Discussions:
+ Attend and serve as active participant in project and Clinical Monitoring department team meetings and study-specific meetings and attend Investigator and Study Coordinator Meetings (in person or virtual)
+ Participate in cross-functional team discussions to provide updates on field monitoring activities and ensure achievement of study milestones
+ Corporate, Therapeutic and Industry Training:
+ Attain a thorough understanding of the diagnostic / therapeutic area and UTC product (s) for assigned study(ies)
+ Attend relevant conferences, scientific meetings and corporate offered training sessions, as required/necessary, to remain current on therapeutic areas under study for UTC products and industry practices
+ Identify training needs across field monitoring and provide support for the creation, development and/or training to meet those needs, inclusive of lessons learned sharing across the study team members and Clinical Monitoring department
Department Duties:
+ Assist with interviews of CRA candidates and on-boarding of CRAs new hires, as needed
+ Serve as a mentor to junior CRA staff to develop best practices and ensure efficient/effective field monitoring activities to be applied across studies
+ May sign-off on CRAs' capability to independently perform SEVs, SIVs, IMVs and COVs
+ Evaluate new technologies, practices, procedures, methods for best practices as needed/applicable
+ Contribute to strategic decision making in area of expertise regarding clinical monitoring processes
+ Perform other duties as assigned
For this role you will need
Minimum Requirements
+ Bachelor’s Degree preferably in a health, biological sciences, or related field or
+ Registered Nurse (RN) nursing qualifications or relevant clinical research experience in pharmaceutical/biotech/medical device or CRO industry may be considered
+ Experience in monitoring in-patient or complex studies, and/or therapeutic areas of transplant, end stage renal disease, chronic kidney disease, cardiovascular disease, cardiac or other implantable devices
+ 8+ years of relevant pharmaceutical industry experience
+ 5+ years of direct clinical research associate experience
+ Working knowledge and understanding of the clinical trial process; including ICH-GCPs, FDA regulations and familiarity with global regulatory bodies
+ Proficient in performing all clinical trial tasks required of a CRA
+ Experience in all stages of a clinical trial (start-up, maintenance, and close-out)
+ Experience with development of clinical monitoring plan (CMP)
+ Proficient with File/Document Management Platforms such as PlexGlobal, WingSpan, Veeva and Signature Software such as Adobe Acrobat and DocuSign
+ EDC platforms such as Medidata RAVE, Oracle InForm, Medrio, Veeva EDC
+ Competent end user of Microsoft Office suite (Outlook, Word, Excel, PowerPoint)
+ Experience with communication systems such as Microsoft Teams, WebEx, GoToMeeting
+ Attention to detail and accuracy of work
+ Good communication skills, written and verbal
+ Excellent interpersonal and customer service skills
+ Creative problem solving
+ Ability to work independently and as part of a cross-functional team
+ Effective time management and organizational skills
+ Ability to multi-task in a demanding and rapidly changing environment
+ Ability to work a flexible work week; inclusive of evenings and/or weekends
Preferred Qualifications
+ Ability to handle high workloads, stressful situations and meet deadlines
The salary for this position ranges from $126,000 to $145,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities.
The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
_While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients._
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.
How you’ll contribute
Serves as an expert in Clinical Monitoring activities and processes from study start-up of a clinical study through close-out. Work with monitoring team members and cross functional project team members to ensure efficient and effective conduct of clinical trials; responsible for field and off-site monitoring activities for oversight of a clinical trial to facilitate study enrollment; build effective site relationships; ensure that the rights and well-being of study subjects are protected, reported trial data are accurate, complete, and verifiable from source documents, and the conduct of the study is in compliance with the currently approved protocol, site/UTC Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.
Trial Support Activities:
+ Serve as the primary contact and site manager with advanced expertise for field monitoring activities to convey project information and address questions from study sites, study team members, and Third- Party Vendors (TPVs) on behalf of UTC
+ Attain a thorough understanding of site management tasks and responsibilities necessary to implement compliance with the protocol, applicable regulations/guidelines and UTC Standard Operating Procedures (SOPs)
+ Develop and maintain collaborative working relationships with study sites
+ Accountable for subject safety, data integrity and regulatory compliance for assigned sites
+ Monitor recruitment through study applicable systems (IXRS, EDC) and/or communication with site staff; track subject enrollment and participation at each trial site including executing and maintaining enrollment plans
+ Ensure regulatory documents are collected, reviewed, processed, and submitted to the electronic Trial Master File (eTMF) throughout the lifecycle of any assigned studies in collaboration with the assigned In-house CRA (iCRA) and study team, as applicable
+ Perform inspection readiness activities within the eTMF throughout the lifecycle of any assigned studies, including archiving procedures at the time of study termination
+ Maintain site information and communication reports within the UTC eTMF and other study tracking tools
+ Perform virtual/on-site monitoring visits (i.e. evaluation, initiation, interim and close-out) as required by the monitoring plan for assigned studies
+ Provide training to site staff as needed via onsite/remote (phone or teleconference/web meeting) on protocol, study/vendor technology, sponsor and regulatory requirements for study conduct
+ Work through complex site issues and collaborate with high level site staff with minimal supervision/escalation needed
+ Review the quality and integrity of clinical data via Source Document Review/Source Data Verification (SDR/SDV) to ensure assigned study sites' adherence to the protocol, eCRF completion guidelines and regulations
+ Responsible for issuance, review and closure of queries to address data discrepancies between source and clinical data reported in the study specified CRF (paper or electronic)
+ Drive the reporting, tracking, and management of site non-compliance (e.g. protocol deviations, GCP deviations and/or violations)
+ Provide advanced level support to the study team in preparation for audits/inspections; provide response for the quality and completeness of clinical trial documentation; may collaborate with the In-house CRA (iCRA), Monitoring Team Lead (MTL), Management or other study team members to ensure appropriate oversight of Corrective and Preventative Action (CAPA) with study sites
+ Monitor site performance and implement action plans for study sites not meeting expectations in conjunction with the assigned iCRA and study assigned MTL, as applicable
+ Create confirmation letters, monitoring visit reports and follow-up letters for each monitoring visit using either a clinical trial management system (CTMS) or study-specific process
+ Support Study Product (SP) activities at site level for assigned study(ies); inclusive of assessing supply, reviewing and providing input on IXRS and SP accountability / reconciliation at sites, tracking expiry dates and returning of SP
+ Regularly meet with Principal Investigators and site staff during remote/on-site visits for assigned sites to keep them apprised of issues/concerns affecting the study
+ May function as a Lead CRA; tasked with performing specific Monitoring Team Lead (MTL) duties, as necessary
+ Drive data cleaning efforts with Investigative Sites in preparation for study interim analysis and database lock
Meeting Attendance and Discussions:
+ Attend and serve as active participant in project and Clinical Monitoring department team meetings and study-specific meetings and attend Investigator and Study Coordinator Meetings (in person or virtual)
+ Participate in cross-functional team discussions to provide updates on field monitoring activities and ensure achievement of study milestones
+ Corporate, Therapeutic and Industry Training:
+ Attain a thorough understanding of the diagnostic / therapeutic area and UTC product (s) for assigned study(ies)
+ Attend relevant conferences, scientific meetings and corporate offered training sessions, as required/necessary, to remain current on therapeutic areas under study for UTC products and industry practices
+ Identify training needs across field monitoring and provide support for the creation, development and/or training to meet those needs, inclusive of lessons learned sharing across the study team members and Clinical Monitoring department
Department Duties:
+ Assist with interviews of CRA candidates and on-boarding of CRAs new hires, as needed
+ Serve as a mentor to junior CRA staff to develop best practices and ensure efficient/effective field monitoring activities to be applied across studies
+ May sign-off on CRAs' capability to independently perform SEVs, SIVs, IMVs and COVs
+ Evaluate new technologies, practices, procedures, methods for best practices as needed/applicable
+ Contribute to strategic decision making in area of expertise regarding clinical monitoring processes
+ Perform other duties as assigned
For this role you will need
Minimum Requirements
+ Bachelor’s Degree preferably in a health, biological sciences, or related field or
+ Registered Nurse (RN) nursing qualifications or relevant clinical research experience in pharmaceutical/biotech/medical device or CRO industry may be considered
+ Experience in monitoring in-patient or complex studies, and/or therapeutic areas of transplant, end stage renal disease, chronic kidney disease, cardiovascular disease, cardiac or other implantable devices
+ 8+ years of relevant pharmaceutical industry experience
+ 5+ years of direct clinical research associate experience
+ Working knowledge and understanding of the clinical trial process; including ICH-GCPs, FDA regulations and familiarity with global regulatory bodies
+ Proficient in performing all clinical trial tasks required of a CRA
+ Experience in all stages of a clinical trial (start-up, maintenance, and close-out)
+ Experience with development of clinical monitoring plan (CMP)
+ Proficient with File/Document Management Platforms such as PlexGlobal, WingSpan, Veeva and Signature Software such as Adobe Acrobat and DocuSign
+ EDC platforms such as Medidata RAVE, Oracle InForm, Medrio, Veeva EDC
+ Competent end user of Microsoft Office suite (Outlook, Word, Excel, PowerPoint)
+ Experience with communication systems such as Microsoft Teams, WebEx, GoToMeeting
+ Attention to detail and accuracy of work
+ Good communication skills, written and verbal
+ Excellent interpersonal and customer service skills
+ Creative problem solving
+ Ability to work independently and as part of a cross-functional team
+ Effective time management and organizational skills
+ Ability to multi-task in a demanding and rapidly changing environment
+ Ability to work a flexible work week; inclusive of evenings and/or weekends
Preferred Qualifications
+ Ability to handle high workloads, stressful situations and meet deadlines
The salary for this position ranges from $126,000 to $145,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities.
The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
_While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients._
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
Source : United Therapeutics