Clinical research coordinator jobs in Indianapolis, IN - 42 jobs
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Senior Clinical Research Associate
Clinical Research Scientist - Breast Cancer Franchise
Eli Lilly and Company 4.6
Clinical research coordinator job in Indianapolis, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Position Overview:
The Development ClinicalResearch Scientist (CRS) in the Breast Cancer Franchise will be primarily focused on late phase assets in an evolving portfolio. This role is pivotal in the design, execution, and analysis of clinical trials that support the development of innovative breast cancer therapies. The CRS ensures that all medical team activities align with the medical vision and stay in sync with current regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly policies.
This position requires close collaboration with cross-functional partners including medical affairs, clinical operations, regulatory, statistics and data science to advance the oncology pipeline and improve patient outcomes. The successful candidate will proactively identify, assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities.
This role includes supervisory responsibilities and requires demonstrated leadership inclinical development, strong mentoring capabilities, and exceptional written communication skills-particularly for external data disclosures and regulatory documentation.
Primary Responsibilities
Contribute to the development and execution of clinical strategies for breast cancer programs. Maintain a focus on accelerating timelines while ensuring quality.
Demonstrate compliance with procedures and be accountable for compliance of team members.
Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports.
Lead and contribute in medical monitoring activities, including data review, safety assessments, and protocol deviation management.
Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence.
Collaborate with Global Patient Safety on risk management planning.
Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions.
Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training.
Partake in data analysis, scientific dissemination, and preparation of final study reports.
Analyze and contextualize clinical data to support decision-making and portfolio strategy.
Contribute to strategy and innovation through cross-functional working groups.
Support planning and execution of symposia, advisory boards, and other external engagements.
Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts.
Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions.
Scientific & Technical Expertise and Development
Stay current with medical literature and scientific developments in breast oncology.
Maintain deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data.
Provide scientific consultation to medical affairs, health outcomes, and commercial teams.
Assist in planning and execution of opportunities for external scientific engagement and attend relevant symposia.
Leadership & Professional Development
Model leadership behaviors and lead matrixed, cross-functional teams. Direct supervision of a team of more junior scientists.
Set and help members of the team pursue developmental goals though coaching to drive exceptional team performance while elevating the individual.
Basic qualifications:
PhD with 3+ years of industry experience) OR (BS Degree and experience in Health-related field with 10+ years' industry experience
3+ years of clinicalresearch scientist experience/clinical trial experience
Leadership experience
Additional Information/Preferences:
Direct Line Leadership experience Breast cancer disease state knowledge/experience
An advanced health/medical/scientific graduate degree such as, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner)
Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission.
Strong communication, interpersonal, teamwork, organizational, and negotiation skills
Demonstrated ability to influence others (both cross-functionally and within the function) to build a positive working environment.
Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.
Fluent in English, verbal and written communication
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$177,000 - $308,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$177k-308k yearly Auto-Apply 36d ago
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Clinical Research Associate (CRA)
Pharmavise Corporation
Clinical research coordinator job in Indianapolis, IN
Job Description
.
We are seeking experienced ClinicalResearch Associates (CRAs) to provide surge capacity support for ongoing clinicalresearch projects. This role focuses on study maintenance and closeout activities, ensuring efficient project execution. The CRA will serve as a primary point of contact for study teams and external partners, supporting essential clinical operations without direct involvement in study startup activities.
Key Responsibilities:
Oversee study-level project management tasks, including study maintenance, data lock, closeout, document review, and budget monitoring.
Act as the primary liaison between internal study teams and external third-party organizations (TPOs).
Track and monitor safety, biomarker, pharmacokinetic (PK), anti-drug antibody (ADA) samples, imaging data, and connected device data.
Manage and track clinical queries to ensure timely resolution.
Collaborate with internal teams to align clinicalresearch processes and operational strategies.
Coordinate with business partners and TPOs to facilitate data delivery and ensure compliance with study requirements.
Minimum Qualifications:
Bachelor's degree in a relevant field.
6+ years of experience inclinicalresearch or a related industry.
Experience as a ClinicalResearch Associate, ClinicalResearchCoordinator, or ClinicalResearch Assistant.
3+ years of experience in project management or a related role.
Prior experience in pharmaceutical, diagnostics, or CRO environments.
Strong organizational skills with attention to detail.
Ability to effectively communicate with diverse stakeholders.
Proficiency in Microsoft Excel for data tracking and reporting.
Experience with clinical trial management tools such as Medidata RAVE, Veeva Vault, Oracle InForm, or similar platforms.
Familiarity with electronic Trial Master File (eTMF) systems, query management tools, and safety reporting databases.
Working knowledge of GCP (Good Clinical Practice) guidelines and regulatory compliance requirements.
In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well-being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work-life balance while providing the necessary support for professional and personal growth.
Be part of our network of Subject Matter Experts.
E-Verify Participation:
Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at ************ or through their website at dhs.gov/e-verify.
$52k-83k yearly est. 4d ago
Clinical Research Scientist - Breast Cancer Franchise
Lilly 4.3
Clinical research coordinator job in Indianapolis, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
**Position Overview:**
The **Development ClinicalResearch Scientist** (CRS) in the **Breast Cancer Franchise** will be primarily focused on late phase assets in an evolving portfolio. This role is pivotal in the design, execution, and analysis of clinical trials that support the development of innovative breast cancer therapies. The CRS ensures that all medical team activities align with the medical vision and stay in sync with current regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly policies.
This position requires close collaboration with cross-functional partners including medical affairs, clinical operations, regulatory, statistics and data science to advance the oncology pipeline and improve patient outcomes. The successful candidate will proactively identify, assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities.
This role includes supervisory responsibilities and requires demonstrated leadership inclinical development, strong mentoring capabilities, and exceptional written communication skills-particularly for external data disclosures and regulatory documentation.
**Primary Responsibilities**
+ Contribute to the development and execution of clinical strategies for breast cancer programs. Maintain a focus on accelerating timelines while ensuring quality.
+ Demonstrate compliance with procedures and be accountable for compliance of team members.
+ Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports.
+ Lead and contribute in medical monitoring activities, including data review, safety assessments, and protocol deviation management.
+ Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence.
+ Collaborate with Global Patient Safety on risk management planning.
+ Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions.
+ Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training.
+ Partake in data analysis, scientific dissemination, and preparation of final study reports.
+ Analyze and contextualize clinical data to support decision-making and portfolio strategy.
+ Contribute to strategy and innovation through cross-functional working groups.
+ Support planning and execution of symposia, advisory boards, and other external engagements.
+ Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts.
+ Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions.
**Scientific & Technical Expertise and Development**
+ Stay current with medical literature and scientific developments in breast oncology.
+ Maintain deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data.
+ Provide scientific consultation to medical affairs, health outcomes, and commercial teams.
+ Assist in planning and execution of opportunities for external scientific engagement and attend relevant symposia.
**Leadership & Professional Development**
+ Model leadership behaviors and lead matrixed, cross-functional teams. Direct supervision of a team of more junior scientists.
+ Set and help members of the team pursue developmental goals though coaching to drive exceptional team performance while elevating the individual.
**Basic qualifications:**
+ PhD with 3+ years of industry experience) OR (BS Degree and experience in Health-related field with 10+ years' industry experience
+ 3+ years of clinicalresearch scientist experience/clinical trial experience
+ Leadership experience
**Additional Information/Preferences:**
+ Direct Line Leadership experience Breast cancer disease state knowledge/experience
+ An advanced health/medical/scientific graduate degree such as, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner)
+ Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission.
+ Strong communication, interpersonal, teamwork, organizational, and negotiation skills
+ Demonstrated ability to influence others (both cross-functionally and within the function) to build a positive working environment.
+ Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.
+ Fluent in English, verbal and written communication
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$177,000 - $308,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
\#WeAreLilly
$73k-118k yearly est. 60d+ ago
Senior Clinical Research Associate (level dependent on experience)
CTI Clinical Trial Services 3.7
Clinical research coordinator job in Indianapolis, IN
Senior ClinicalResearch Associate (home based) (Level dependent on experience) To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance. Additionally, all CRAs are able keep their hotel points and airline miles and are offered a home office allowance.
Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts.
What You'll Do
Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Project Manager / sponsor.
Creates and implements subject enrollment strategies for assigned investigative sites.
Conducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the Monitoring Plan.
Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material.
Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SCV), regulatory documents, and investigational product.
Participates in development of CRFs and other study related documents
What You Bring
Bachelor's or Master's Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or
RN with Associate's Degree or 3-year Nursing Diploma with at least 2 years of clinical nursing experience
Why CTI? At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward. For that reason, we treat our team members with the respect they deserve, and our numbers show it:
We support career progression - We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward
We value education and training - We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department
We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave.
Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry
We think globally and act locally - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.
We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs
Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market
$62k-97k yearly est. 60d+ ago
Clinical Project Manager
Global Channel Management
Clinical research coordinator job in Indianapolis, IN
Clinical Project Manager needs 5+ years experience
Clinical Project Manager requires:
Onsite
Clinical Project management
MS Project, SAP, IMPACT etc.
Accurately forecast and track direct expenses for clinical budgets Document key team information and clinical decisions in Chorus custom tracking and communication database
Manage clinical operational risks and their impact to the timelines and budgets of clinical studies, including critical path activities
Select and manage external network of vendors to ensure on time and on budget clinical project deliverables
Establish and manage Clinical vendor expectations, performance, and delivery
Serve as the central point of contact for the global clinical team, to resolve clinical implementation issues (internal and external), lead risk assessments and contingency planning, and effective communication across and upward
Partner with regulatory and medical to ensure safety management and monitoring processes are implemented
Provide input into molecule development, clinical regulatory and safety strategy
Manage global cross-functional communication and escalations to ensure alignment on delivery and execution
Utilize clinical operations process knowledge to drive decision making.
Participate in review of clinical database specifications and utilization
$78k-115k yearly est. 60d+ ago
Clinical Research Coordinator II
Care Access 4.3
Clinical research coordinator job in Indianapolis, IN
Job Description
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like
Future of Medicine
, which makes advanced health screenings and research opportunities accessible to communities worldwide, and
Difference Makers
, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinicalresearch and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit *******************
How This Role Makes a Difference
The ClinicalResearchCoordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinicalresearch study subjects while ensuring protocol and regulatory compliance.
How You'll Make An Impact
Duties include but not limited to:
Ability to understand and follow institutional SOPs.
Review and assess protocol (including amendments) for clarity, logistical feasibility
Ensure that all training and study requirements are met prior to trial conduct.
Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.
Assist with planning and creation of appropriate recruitment materials
Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.
Actively work with recruitment team in calling and recruiting subjects
Attend Investigator meetings as required.
Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
Assist in the creation and review of source documents.
Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
Study Management
Prioritize activities with specific regard to protocol timelines
Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
Maintain effective relationships with study participants and other care Access Research personnel.
Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.
Communicate clearly verbally and in writing.
Patient Coordination
Prescreen study candidates
Obtain informed consent per Care Access Research SOP
Complete visit procedures in accordance with protocol.
Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.
Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
Documentation
Record data legibly and enter in real time on paper or e-source documents
Accurately record study medication inventory, medication dispensation, and patient compliance.
Resolve data management queries and correct source data within sponsor provided timelines
Assist regulatory personnel with completion and filing of regulatory documents.
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
The Expertise Required
Excellent working knowledge of medical and research terminology
Excellent working knowledge of federal regulations, good clinical practices (GCP)
Ability to communicate and work effectively with a diverse team of professionals.
Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail
Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.
Critical thinker and problem solver
Friendly, outgoing personality; maintain a positive attitude under pressure.
High level of self-motivation and energy
Excellent professional writing and communication skills
Ability to work independently in a fast-paced environment with minimal supervision.
Certifications/Licenses, Education, and Experience:
Bachelor's Degree preferred, or equivalent combination of education, training and experience.
A minimum of 3 years prior ClinicalResearchCoordinator experience required
Prefer 1 year of experience as a Care Access ResearchClinicalResearchCoordinator
Recent phlebotomy experience required
Bilingual in Spanish-preferred
How We Work Together
Location: This is an on-site position with regional commute requirements. Position requires onsite work 5 days per week at the Indianapolis, INclinic.
Travel: Regularly planned travel within the region will be required as part of the role.
Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members.
Benefits & Perks (US Full Time Employees)
Paid Time Off (PTO) and Company Paid Holidays
100% Employer paid medical, dental, and vision insurance plan options
Health Savings Account and Flexible Spending Accounts
Bi-weekly HSA employer contribution
Company paid Short-Term Disability and Long-Term Disability
401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
$60k-90k yearly 4d ago
Clinical Research Coordinator
Indiana Hemophilia & Thrombosis Center 4.3
Clinical research coordinator job in Indianapolis, IN
About IHI
At Innovative Hematology, Inc. (IHI), we offer a future where people with rare blood disorders flourish. Our experts provide the highest quality comprehensive services and holistic care to patients with bleeding, clotting and other hematologic disorders, and to their families.
What You Will Do
As a ClinicalResearchCoordinator, you will be responsible for executing research projects under the direction of the primary investigator and for performing in accordance to study regulatory processes, standard operating procedures, and study protocols.
The Opportunity
Participate in the planning and execution of research projects under the direction of the Medical Director and the primary investigator.
Function as an integral part of the research and comprehensive care teams, working with colleagues to meet deadlines and maintain a flexible schedule based on the needs of patients, the department, and IHI.
Create a study budget in InfoED in collaboration with the finance department. Work with the finance department to assist with billing, invoicing, tracking status on payments due or past due, documenting patient stipend requests, and charting completed study visits.
Assess patients for inclusion and exclusion criteria to determine study eligibility, and work cooperatively with the comprehensive team to coordinate study-related patient care. Explain informed consent for each study participant; document refusals according to protocol.
Ensure accurate and prompt communication with patients, the primary investigator, research manager, external contacts, study sponsors, and monitors.
Prepare study-related documentation such as protocol worksheets, procedural manuals, drug dispensation records, regulatory forms, adverse event reports; submit all relevant study documents to the institutional review board.
Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices. Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
Participate in internal quality assurance; review monitor reports for trends across studies.
Requirements
Minimum Associate's degree in related field required.
Minimum 1 year of related experience required.
Valid Indiana Driver's license and automobile insurance required.
All IHI employees are expected to enable multi-factor authentication via their personal smart phone/smart device in order to access IHI systems as a requirement of the role.
Benefits
IHI is a not-for-profit program based inIndianapolis and offers a competitive salary and benefit package.
IHI is the only federally designated comprehensive hemophilia program inIndiana and serves the entire state through services available inIndianapolis and at outreach clinics.
IHI is a leader in hemophilia care, education and clinicalresearch and has a dedicated on-site multidisciplinary staff to ensure availability of a wide range of required services.
IHI participates in national and international clinicalresearch, including new infusion products and therapies, investigation of long-term outcomes, and the impact of associated conditions. The IHI research program provides patients access to new therapies, and an opportunity to improve care. Our center has more than 50 clinicalresearch projects involving bleeding disorders, sickle cell disease, thrombosis and more.
Innovative Hematology, Inc. is an Equal Opportunity Employer.
$47k-67k yearly est. Auto-Apply 60d+ ago
Clinical Research Coordinator
Innovative Hematology, Inc.
Clinical research coordinator job in Indianapolis, IN
Job Description
About IHI
At Innovative Hematology, Inc. (IHI), we offer a future where people with rare blood disorders flourish. Our experts provide the highest quality comprehensive services and holistic care to patients with bleeding, clotting and other hematologic disorders, and to their families.
What You Will Do
As a ClinicalResearchCoordinator, you will be responsible for executing research projects under the direction of the primary investigator and for performing in accordance to study regulatory processes, standard operating procedures, and study protocols.
The Opportunity
Participate in the planning and execution of research projects under the direction of the Medical Director and the primary investigator.
Function as an integral part of the research and comprehensive care teams, working with colleagues to meet deadlines and maintain a flexible schedule based on the needs of patients, the department, and IHI.
Create a study budget in InfoED in collaboration with the finance department. Work with the finance department to assist with billing, invoicing, tracking status on payments due or past due, documenting patient stipend requests, and charting completed study visits.
Assess patients for inclusion and exclusion criteria to determine study eligibility, and work cooperatively with the comprehensive team to coordinate study-related patient care. Explain informed consent for each study participant; document refusals according to protocol.
Ensure accurate and prompt communication with patients, the primary investigator, research manager, external contacts, study sponsors, and monitors.
Prepare study-related documentation such as protocol worksheets, procedural manuals, drug dispensation records, regulatory forms, adverse event reports; submit all relevant study documents to the institutional review board.
Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices. Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
Participate in internal quality assurance; review monitor reports for trends across studies.
Requirements
Minimum Associate's degree in related field required.
Minimum 1 year of related experience required.
Valid Indiana Driver's license and automobile insurance required.
All IHI employees are expected to enable multi-factor authentication via their personal smart phone/smart device in order to access IHI systems as a requirement of the role.
Benefits
IHI is a not-for-profit program based inIndianapolis and offers a competitive salary and benefit package.
IHI is the only federally designated comprehensive hemophilia program inIndiana and serves the entire state through services available inIndianapolis and at outreach clinics.
IHI is a leader in hemophilia care, education and clinicalresearch and has a dedicated on-site multidisciplinary staff to ensure availability of a wide range of required services.
IHI participates in national and international clinicalresearch, including new infusion products and therapies, investigation of long-term outcomes, and the impact of associated conditions. The IHI research program provides patients access to new therapies, and an opportunity to improve care. Our center has more than 50 clinicalresearch projects involving bleeding disorders, sickle cell disease, thrombosis and more.
Innovative Hematology, Inc. is an Equal Opportunity Employer.
$40k-59k yearly est. 22d ago
Clinical Project Manager
Azenta
Clinical research coordinator job in Plainfield, IN
Azenta Inc.At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships.
All we accomplish is grounded in our core values of Customer Focus, Achievement, Accountability, Teamwork, Employee Value and IntegrityJob TitleClinical Project ManagerJob Description
How You'll Add Value
The Clinical Project Manager within the Project Management Organization (PMO) is expected to provide project management support to internal team members, as well as customers, to deliver Azenta Life Sciences solutions to clients, partners, and alliances. Under guidance from the Director, Clinical Program Management, the Clinical Project Manager is expected to gain an in-depth understanding of the key clients and become an expert in Azenta Life Sciences services.
What You'll Do
Serve as the primary client contact for assigned projects and establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business. Ensure that all customer expectations are documented and acted upon in compliance with regulatory requirements. Able to act efficiently in an environment with dynamic timelines and priorities. Accountable for the monitoring and reporting of performance metrics. Create required project plans. Implement and monitor progress against project plans and revise as necessary. Monitor project schedule and scope to ensure both remain on track. Project support may include kit provision and logistics, sample management, lab services support, relocation services, training, management, or support of alliances/ partnerships. Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to both Azenta Life Sciences and client requirements. Participate in pre-sale discussion and client meetings as required. Actively participate in Azenta Life Sciences development through continuous process improvement, quality, and productivity. Mentor Client Coordinator as needed. Managing queries and resolutions.
What You Will Bring
Bachelor's degree in science or related field with a minimum of 1 year of experience in a regulated industry environment.
OR High School Diploma or minimum of 5 years of experience in a regulated industry environment.
Strong organizational skills and attention to detail.
Excellent verbal and written communication skills; presentation skills, ability to engage in effective problem-solving conversations.
Demonstrated ability to complete long-range projects as assigned.
Demonstrated ability to prioritize work, customers, internal and external demands.
Your Working Conditions
Hybrid - Indianapolis
(aligned to company policy 4 days in office)
.
The Employee may occasionally work in an area with potentially infectious materials.
The Employee will be responsible for maintaining a clean work environment and enforcing and following Universal Precautions for bloodborne pathogens when working in an area considered to be potentially contaminated.
EOE M/F/Disabled/VET
If any applicant is unable to complete an application or respond to a job opening because of a disability, please email at ********************* for assistance.
Azenta is an Equal Opportunity Employer. This company considers candidates regardless of race, color, age, religion, gender, sexual orientation, gender identity, national origin, disability or veteran status.
United States Base Compensation: $60,000.00 - $75,000.00
The posted pay range for this position is an estimate based on current market data and internal pay structure. Final compensation may vary above or below this range depending on factors such as experience, education (including licensure and certifications), qualifications, performance, and geographic location, among other relevant business or organizational needs.
$60k-75k yearly Auto-Apply 3d ago
Clinical Project Manager
Azenta Inc.
Clinical research coordinator job in Plainfield, IN
Azenta Inc. At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships.
All we accomplish is grounded in our core values of Customer Focus, Achievement, Accountability, Teamwork, Employee Value and Integrity
Job Title
Clinical Project Manager
Job Description
How You'll Add Value
The Clinical Project Manager within the Project Management Organization (PMO) is expected to provide project management support to internal team members, as well as customers, to deliver Azenta Life Sciences solutions to clients, partners, and alliances. Under guidance from the Director, Clinical Program Management, the Clinical Project Manager is expected to gain an in-depth understanding of the key clients and become an expert in Azenta Life Sciences services.
What You'll Do
Serve as the primary client contact for assigned projects and establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business. Ensure that all customer expectations are documented and acted upon in compliance with regulatory requirements. Able to act efficiently in an environment with dynamic timelines and priorities. Accountable for the monitoring and reporting of performance metrics. Create required project plans. Implement and monitor progress against project plans and revise as necessary. Monitor project schedule and scope to ensure both remain on track. Project support may include kit provision and logistics, sample management, lab services support, relocation services, training, management, or support of alliances/ partnerships. Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to both Azenta Life Sciences and client requirements. Participate in pre-sale discussion and client meetings as required. Actively participate in Azenta Life Sciences development through continuous process improvement, quality, and productivity. Mentor Client Coordinator as needed. Managing queries and resolutions.
What You Will Bring
* Bachelor's degree in science or related field with a minimum of 1 year of experience in a regulated industry environment.
* OR High School Diploma or minimum of 5 years of experience in a regulated industry environment.
* Strong organizational skills and attention to detail.
* Excellent verbal and written communication skills; presentation skills, ability to engage in effective problem-solving conversations.
* Demonstrated ability to complete long-range projects as assigned.
* Demonstrated ability to prioritize work, customers, internal and external demands.
Your Working Conditions
* Hybrid - Indianapolis (aligned to company policy 4 days in office) .
* The Employee may occasionally work in an area with potentially infectious materials.
* The Employee will be responsible for maintaining a clean work environment and enforcing and following Universal Precautions for bloodborne pathogens when working in an area considered to be potentially contaminated.
EOE M/F/Disabled/VET
If any applicant is unable to complete an application or respond to a job opening because of a disability, please email at ********************* for assistance.
Azenta is an Equal Opportunity Employer. This company considers candidates regardless of race, color, age, religion, gender, sexual orientation, gender identity, national origin, disability or veteran status.
United States Base Compensation: $60,000.00 - $75,000.00
The posted pay range for this position is an estimate based on current market data and internal pay structure. Final compensation may vary above or below this range depending on factors such as experience, education (including licensure and certifications), qualifications, performance, and geographic location, among other relevant business or organizational needs.
$60k-75k yearly 2d ago
Full-Time Dialysis Clinical Coordinator
Rendevor Dialysis
Clinical research coordinator job in Plainfield, IN
Job Description
Who is Rendevor Dialysis?
We are a family-owned and operated company founded over 30 years ago by a Dialysis RN who believes everyone is entitled to excellent medical treatment from talented clinicians.
Our Mission
To bring thriving onsite dialysis partnerships to any under-serviced healthcare institution in need.
What's In It For You?
Our company offers a competitive total rewards package above industry standards in most markets and we pride ourselves in providing a caring, positive culture for our employees.
We offer an extremely generous package including:
Hourly Rate: $62.00 - $65.00/Per Hour (Based on Documented Experience, Qualifications and Market Data)
Fantastic employee benefit package
Employer contribution to H.S.A.
F.S.A. tax savings benefits
A 4% dollar-for-dollar company match to the 401k plan with immediate vesting
A generous PTO accrual program
A PTO cash-out provision
Tuition reimbursement program
Employee referral bonus program
Robust employee recognition and appreciation program
Quality employee training and development programs
Several holidays paid at time and a half
Annual holiday gift bags for all employees
Comprehensive Medical Benefits
Vision
Dental
STD/LTD/Voluntary Life
Accident, Critical Illness and Hospital Indemnity Plans
Pet Insurance
Discounted auto and home insurance
Discounted legal services program
Employer-paid life insurance for 1x employee salary
Employer-paid assistance program with complimentary counseling, wellness, and legal sessions for employees and household members
Complimentary year-long weight loss program
Health & Wellness Program with gift card giveaways
What You'll Do:
The ClinicalCoordinator (CC) is responsible for all overall operations and activities of the smaller-sized dialysis units operated by Rendevor Dialysis. Through effective leadership, professionalism, and management, the ClinicalCoordinator uses clinical/nursing knowledge and dialysis experience to ensure quality measures are met by delivering safe dialysis treatments.
The ClinicalCoordinator develops, trains, coaches, acts as a resource and oversees clinical teammates assigned to the unit as well ass coordinates activities with the technical personnel.
The ClinicalCoordinator provides excellent customer service and maintains strong relationships through effective communication and visibility with providers, DOC/BOP, Managed Healthcare Organization, Post Acute, Hospitals, etc.
As required by the Regional Director, the ClinicalCoordinator is responsible for financial management such as inventory/supplies, accurate staffing efficiencies and ensuring compliance with applicable company and state regulatory requirements.
Reports to the Regional Director as assigned.
This dialysis unit is located in:
Plainfield, IN, within Plainfield Correctional Facility
This dialysis unit operates:
Monday - Saturday from 5:00 am - 4:30 pm
you will also cover the following dialysis unit located in:
This dialysis unit is located in:
Indianapolis, IN within Marion County Jail
This dialysis unit operates:
Operates Monday/Wednesday/Friday (shift depends on the number patients)
As in any setting, this involves teamwork and coordinating care with the healthcare team. In addition to the healthcare team, you are also required to maintain strong relationships, regular communication, and visibility with clients (site Managed Healthcare, DOC/BOP, etc.)
Minimum Qualifications
Education and Experience
Graduation from an Accredited Nursing School or Equivalent
Current RN License for Indiana & current CPR certification (or within three months of hire)
One year of Hemodialysis RN experience is required
Previous management experience preferred
Required Skills and Competencies
Ability to read, write, speak, understand and satisfactorily communicate in English.
Strong technical/computer proficiency with laptops, tablets, Outlook, Excel, PowerPoint, Word, SharePoint, etc.
Ability to quickly learn a variety of technical systems and equipment
Essential Duties and Responsibilities:
Leadership
In conjunction with Regional Director, ensures that dialysis unit operates in compliance with all HIPAA, OSHA, ESRD, state and federal regulations, as well as company policies and procedures.
Leads, coaches, and guides other clinical teammates, depending on unit size.
May be required to monitor clinical teammate in-servicing and skills checks.
Delegates tasks as necessary to maximize time and efficiency.
Holds “team huddles” to discuss unit goals and objectives and delivers pertinent corporate communication.
Ensures company policies and procedures are maintained for continuity across the company.
Utilizes a variety of systems (MPulse, EMR, ADP, HCP, Equipment, etc.) and ensures compliance of the team.
Participates in onboarding, training, and educating new hires.
Ensures teammates have been properly in-serviced and checked off on skills.
Staffing
Manages staff scheduling and assignments to maintain appropriate patient to staffing ratios. This includes approving and/or denying PTO requests, sending teammates home for low patient census, managing overtime, etc.
Maintains contact with PRN bench staff, coordinating requirements for needed schedules
Facilitates staff development, training, and monthly education.
Is responsible to ensure all clinical teammates maintain license and/or certifications, and do not operate in unit if lapsed.
Participates in employee appreciation events and planning, based on provided budget from Regional Director.
Incoordination with Regional Director, may need to be involved with teammate corrective action plans and annual evaluations of teammates.
Communicates staffing needs with RD and Talent Partner.
Depending on unit size, may be required to participate in interviews and candidate selection.
Encourages employee referrals and may be asked to contact referrals provided by staff.
Clinical
Delivers safe and effective patient care of all treatment modalities
Models thorough and accurate documentation in accordance with industry/client requirements and regulations and holds teammates to same high standards.
Actively participates in patient education, and ensures teammates follow same protocols.
Takes ownership of lab collections and documentation.
Applies critical thinking and time management skills.
Utilizes resources to develop and improve skills, and to monitor quality control measures ensuring continuous quality of patient care.
Depending on unit size and requirements, may be involved with patient care review meetings.
Completion of monthly facility audits (using an audit template provided by the RD). Develops action plans to address any deficiencies.
Acts as on-site liaison to the corporate biomedical team and timely notifies biomedical technician via MPulse of any service request.
Takes ownership of unit safety, cleanliness, and infection control
As appropriate, lobbies with client administration to eliminate any restrictions that may negatively impact patient outcomes, such as infection rate, catheter utilization, AMA rate, refusal rate, etc.
Monitors and assures that the patients receive adequate medical attention while in the dialysis unit.
Maintains the integrity of all protected health information.
Knows and follows policies and procedures of the DOC and Rendevor Dialysis, and monitors staff compliance of same.
Supervises medical records to ensure complete documentation.
Engages in constant learning and research of dialysis practices.
Continuous Quality Improvement/Quality Assurance & Performance Improvemen
Collaborates with the Clinical Services team to meet CQI/QAPI initiatives, clinical goals, and patient outcomes as needed.
Assists or may be responsible for the monthly completion of the Rendevor Application requirements.
Ensures adequate resources for supporting the CQI/QAPI process as applicable.
Communication (internal and external)
Maintains open communication with facility personnel, Managed Care group, providers, Rendevor management team, biomedical team, staff, etc.
May be required to attend and participate in facility meetings.
Checks email daily and responds appropriately and timely; uses company-provided email for all work-related email communications.
Maintains an open-door policy to communicate with teammates.
Maintains professionalism and privacy of confident information.
Payroll
Records both arrival and departure time via ADP's time and attendance system, following the guidelines outlined by Human Resources.
Assists new hires in accessing the time system and demonstrates proper log in/out procedures.
If assigned, approves timesheets of unit teammates in ADP.
Accounting
Timely and accurate review and submission of treatment rosters within two days of month end.
Inventory/Supplies
Accurate and timely submission of unit supply orders to the RAA and RD per the unit schedule.
Responsible for ensuring the unit has adequate supply inventories on hand, that no supplies are expired, and that emergency supply levels are understood/on-hand.
Communicates and coordinates a-typical supply ordering with RD/RAA and purchasing department.
Business Development
Works diligently to be a great on-site partner to our client and be a company advocate to all outside parties.
Actively listens for new opportunities within dialysis industry and sends any potential leads to supervisor.
General
Promotes and implements the Company's mission, vision, and core values.
Displays excellent and professional written/verbal communication skills.
Always maintains a professional demeanor; keeps an “open door” policy.
Operates with a high level of responsiveness in providing information and deliverables to supervisors.
Demonstrates a high degree of self-motivation and willingness to improve.
Openly receives and promptly acts upon any feedback from supervisors, peers, clients.
Volunteers to assist colleagues when necessary and assist with various projects as assigned.
Reports any incidents to Regional Director.
Reports work-related injuries to carrier via web portal. Follows up with HR and RD. Collects statement from claimant as well as witness statements.
Must maintain RN license, CPR and a clean background.
Checks company email each working day and responds timely and appropriately; uses company-provided email for all work-related email communications.
Adheres to all company and departmental policies and procedures.
Maintains regular and predictable attendance and punctuality.
Other duties as assigned.
Supervision:
This position will report to the Regional Director.
This position will supervise clinical team members.
Background Check:
The Department of Corrections/Federal Bureau of Prisons and all applicable law require a comprehensive background check for all employees working in this position. This background check will be conducted after an offer, if any, is made.
Work Environment:
This role exists in a hospital, training center, patient residence, or in the medical unit of a post-acute or correctional facility. This role may include exposure to chemicals and blood-borne pathogens. This role routinely involves the use of both medical and standard office equipment. This position cannot be performed remotely.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk and hear. To perform the essential functions of this job, the employee is required to continually stand, and frequently bend, walk, twist, crouch, use hands to handle or feel, and reach with hands and arms. This position requires the ability to push, pull, and lift up to 50 pounds. Specific visual abilities required by this job include close vision and ability to adjust focus. The employee is required to work the full schedule which may range from five to fifteen hours per day, based on the unit requirements (i.e. patient census, staffing needs, etc.)
Rendevor Dialysis is an Equal-Opportunity Employer.
$44k-63k yearly est. 24d ago
Full-Time Dialysis Clinical Coordinator
CDI Health
Clinical research coordinator job in Plainfield, IN
Who is Rendevor Dialysis? We are a family-owned and operated company founded over 30 years ago by a Dialysis RN who believes everyone is entitled to excellent medical treatment from talented clinicians. Our Mission To bring thriving onsite dialysis partnerships to any under-serviced healthcare institution in need.
Whats In It For You?
Our company offers a competitive total rewards package above industry standards in most markets and we pride ourselves in providing a caring, positive culture for our employees.
We offer an extremely generous package including:
Hourly Rate: $62.00 - $65.00/Per Hour (Based on Documented Experience, Qualifications and Market Data)
* Fantastic employee benefit package
* Employer contribution to H.S.A.
* F.S.A. tax savings benefits
* A 4% dollar-for-dollar company match to the 401k plan with immediate vesting
* A generous PTO accrual program
* A PTO cash-out provision
* Tuition reimbursement program
* Employee referral bonus program
* Robust employee recognition and appreciation program
* Quality employee training and development programs
* Several holidays paid at time and a half
* Annual holiday gift bags for all employees
* Comprehensive Medical Benefits
* Vision
* Dental
* STD/LTD/Voluntary Life
* Accident, Critical Illness and Hospital Indemnity Plans
* Pet Insurance
* Discounted auto and home insurance
* Discounted legal services program
* Employer-paid life insurance for 1x employee salary
* Employer-paid assistance program with complimentary counseling, wellness, and legal sessions for employees and household members
* Complimentary year-long weight loss program
* Health & Wellness Program with gift card giveaways
What Youll Do:
* The ClinicalCoordinator (CC) is responsible for all overall operations and activities of the smaller-sized dialysis units operated by Rendevor Dialysis. Through effective leadership, professionalism, and management, the ClinicalCoordinator uses clinical/nursing knowledge and dialysis experience to ensure quality measures are met by delivering safe dialysis treatments.
* The ClinicalCoordinator develops, trains, coaches, acts as a resource and oversees clinical teammates assigned to the unit as well ass coordinates activities with the technical personnel.
* The ClinicalCoordinator provides excellent customer service and maintains strong relationships through effective communication and visibility with providers, DOC/BOP, Managed Healthcare Organization, Post Acute, Hospitals, etc.
* As required by the Regional Director, the ClinicalCoordinator is responsible for financial management such as inventory/supplies, accurate staffing efficiencies and ensuring compliance with applicable company and state regulatory requirements.
* Reports to the Regional Director as assigned.
This dialysis unit is located in:
* Plainfield, IN, within Plainfield Correctional Facility
This dialysis unit operates:
* Monday - Saturday from 5:00 am - 4:30 pm
you will also cover the following dialysis unit located in:
This dialysis unit is located in:
* Indianapolis, IN within Marion County Jail
This dialysis unit operates:
* Operates Monday/Wednesday/Friday (shift depends on the number patients)
As in any setting, this involves teamwork and coordinating care with the healthcare team. In addition to the healthcare team, you are also required to maintain strong relationships, regular communication, and visibility with clients (site Managed Healthcare, DOC/BOP, etc.)
Minimum Qualifications
Education and Experience
* Graduation from an Accredited Nursing School or Equivalent
* Current RN License for Indiana & current CPR certification (or within three months of hire)
* One year of Hemodialysis RN experience is required
* Previous management experience preferred
Required Skills and Competencies
* Ability to read, write, speak, understand and satisfactorily communicate in English.
* Strong technical/computer proficiency with laptops, tablets, Outlook, Excel, PowerPoint, Word, SharePoint, etc.
* Ability to quickly learn a variety of technical systems and equipment
Essential Duties and Responsibilities:
Leadership
* In conjunction with Regional Director, ensures that dialysis unit operates in compliance with all HIPAA, OSHA, ESRD, state and federal regulations, as well as company policies and procedures.
* Leads, coaches, and guides other clinical teammates, depending on unit size.
* May be required to monitor clinical teammate in-servicing and skills checks.
* Delegates tasks as necessary to maximize time and efficiency.
* Holds team huddles to discuss unit goals and objectives and delivers pertinent corporate communication.
* Ensures company policies and procedures are maintained for continuity across the company.
* Utilizes a variety of systems (MPulse, EMR, ADP, HCP, Equipment, etc.) and ensures compliance of the team.
* Participates in onboarding, training, and educating new hires.
* Ensures teammates have been properly in-serviced and checked off on skills.
Staffing
* Manages staff scheduling and assignments to maintain appropriate patient to staffing ratios. This includes approving and/or denying PTO requests, sending teammates home for low patient census, managing overtime, etc.
* Maintains contact with PRN bench staff, coordinating requirements for needed schedules
* Facilitates staff development, training, and monthly education.
* Is responsible to ensure all clinical teammates maintain license and/or certifications, and do not operate in unit if lapsed.
* Participates in employee appreciation events and planning, based on provided budget from Regional Director.
* Incoordination with Regional Director, may need to be involved with teammate corrective action plans and annual evaluations of teammates.
* Communicates staffing needs with RD and Talent Partner.
* Depending on unit size, may be required to participate in interviews and candidate selection.
* Encourages employee referrals and may be asked to contact referrals provided by staff.
Clinical
* Delivers safe and effective patient care of all treatment modalities
* Models thorough and accurate documentation in accordance with industry/client requirements and regulations and holds teammates to same high standards.
* Actively participates in patient education, and ensures teammates follow same protocols.
* Takes ownership of lab collections and documentation.
* Applies critical thinking and time management skills.
* Utilizes resources to develop and improve skills, and to monitor quality control measures ensuring continuous quality of patient care.
* Depending on unit size and requirements, may be involved with patient care review meetings.
* Completion of monthly facility audits (using an audit template provided by the RD). Develops action plans to address any deficiencies.
* Acts as on-site liaison to the corporate biomedical team and timely notifies biomedical technician via MPulse of any service request.
* Takes ownership of unit safety, cleanliness, and infection control
* As appropriate, lobbies with client administration to eliminate any restrictions that may negatively impact patient outcomes, such as infection rate, catheter utilization, AMA rate, refusal rate, etc.
* Monitors and assures that the patients receive adequate medical attention while in the dialysis unit.
* Maintains the integrity of all protected health information.
* Knows and follows policies and procedures of the DOC and Rendevor Dialysis, and monitors staff compliance of same.
* Supervises medical records to ensure complete documentation.
* Engages in constant learning and research of dialysis practices.
Continuous Quality Improvement/Quality Assurance & Performance Improvemen
* Collaborates with the Clinical Services team to meet CQI/QAPI initiatives, clinical goals, and patient outcomes as needed.
* Assists or may be responsible for the monthly completion of the Rendevor Application requirements.
* Ensures adequate resources for supporting the CQI/QAPI process as applicable.
Communication (internal and external)
* Maintains open communication with facility personnel, Managed Care group, providers, Rendevor management team, biomedical team, staff, etc.
* May be required to attend and participate in facility meetings.
* Checks email daily and responds appropriately and timely; uses company-provided email for all work-related email communications.
* Maintains an open-door policy to communicate with teammates.
* Maintains professionalism and privacy of confident information.
Payroll
* Records both arrival and departure time via ADPs time and attendance system, following the guidelines outlined by Human Resources.
* Assists new hires in accessing the time system and demonstrates proper log in/out procedures.
* If assigned, approves timesheets of unit teammates in ADP.
Accounting
* Timely and accurate review and submission of treatment rosters within two days of month end.
Inventory/Supplies
* Accurate and timely submission of unit supply orders to the RAA and RD per the unit schedule.
* Responsible for ensuring the unit has adequate supply inventories on hand, that no supplies are expired, and that emergency supply levels are understood/on-hand.
* Communicates and coordinates a-typical supply ordering with RD/RAA and purchasing department.
Business Development
* Works diligently to be a great on-site partner to our client and be a company advocate to all outside parties.
* Actively listens for new opportunities within dialysis industry and sends any potential leads to supervisor.
General
* Promotes and implements the Companys mission, vision, and core values.
* Displays excellent and professional written/verbal communication skills.
* Always maintains a professional demeanor; keeps an open door policy.
* Operates with a high level of responsiveness in providing information and deliverables to supervisors.
* Demonstrates a high degree of self-motivation and willingness to improve.
* Openly receives and promptly acts upon any feedback from supervisors, peers, clients.
* Volunteers to assist colleagues when necessary and assist with various projects as assigned.
* Reports any incidents to Regional Director.
* Reports work-related injuries to carrier via web portal. Follows up with HR and RD. Collects statement from claimant as well as witness statements.
* Must maintain RN license, CPR and a clean background.
* Checks company email each working day and responds timely and appropriately; uses company-provided email for all work-related email communications.
* Adheres to all company and departmental policies and procedures.
* Maintains regular and predictable attendance and punctuality.
* Other duties as assigned.
Supervision:
* This position will report to the Regional Director.
* This position will supervise clinical team members.
Background Check:
The Department of Corrections/Federal Bureau of Prisons and all applicable law require a comprehensive background check for all employees working in this position. This background check will be conducted after an offer, if any, is made.
Work Environment:
This role exists in a hospital, training center, patient residence, or in the medical unit of a post-acute or correctional facility. This role may include exposure to chemicals and blood-borne pathogens. This role routinely involves the use of both medical and standard office equipment. This position cannot be performed remotely.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk and hear. To perform the essential functions of this job, the employee is required to continually stand, and frequently bend, walk, twist, crouch, use hands to handle or feel, and reach with hands and arms. This position requires the ability to push, pull, and lift up to 50 pounds. Specific visual abilities required by this job include close vision and ability to adjust focus. The employee is required to work the full schedule which may range from five to fifteen hours per day, based on the unit requirements (i.e. patient census, staffing needs, etc.)
Rendevor Dialysis is an Equal-Opportunity Employer.
$44k-63k yearly est. 30d ago
Director - Clinical Research Scientist - Global and US Medical Affairs
Eli Lilly and Company 4.6
Clinical research coordinator job in Indianapolis, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Organization Overview
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Summary
The ClinicalResearch Scientist (CRS) within the Business Unit - Medical Affairs provides scientific and clinical expertise to support product strategy and execute medical plan tactics, customer engagement, and evidence generation. This role ensures that medical insights, clinical data, and regulatory considerations are effectively integrated into local business activities and global development plans.
Key Responsibilities
1. Business & Customer Support
Anticipate and respond to scientific and clinical information needs from healthcare providers, payers, and patient groups.
Lead data analyses and health outcomes research to address customer questions.
Contribute to medical strategy and brand planning in collaboration with global Medical Affairs, GPO/RWE, PRA, and commercial partners.
Provide medical expertise for payer partnerships, promotional material review, and business‑to‑business/government engagements.
Support training of sales, medical, and patient support teams.
Lead definition of Patient Journey and contribute clinical perspective to patient programs.
Participate in relevant professional and industry associations.
2. Scientific Exchange & Data Dissemination
Ensure compliance with global and local regulations governing scientific communication.
Address unsolicited scientific inquiries in alignment with medical governance standards.
Support scientific meetings, advisory boards, symposia, and other expert engagements.
Prepare or review medical letters, slide decks, abstracts, posters, and manuscripts.
Build and maintain relationships with key opinion leaders and scientific societies.
Represent the company at medical congresses and support scientific booth activities.
Contribute to data analyses, publication development, and Clinical Trial Registry reporting.
3. Clinical Planning
Align clinical strategies with regional needs by collaborating with Medical Affairs and global development teams.
Communicate local research needs to ensure Phase I-IV programs reflect market and customer requirements.
Maintain up‑to‑date understanding of clinical and competitive data.
Provide regional clinical insights to inform development plans and study protocols.
4. ClinicalResearch Execution
Review and approve informed consent documents to ensure accurate risk communication.
Partner with clinical operations, statisticians, and investigators throughout study design, initiation, conduct, and close‑out.
Support investigator/site training and address study‑related medical questions.
Oversee local safety monitoring and adverse event follow‑up.
Review investigator‑initiated trial (IIT) proposals as needed.
Ensure global alignment of Phase 3b/4 and applicable early‑phase studies.
5. Regulatory Support
Contribute to development and review of local labeling and labeling changes.
Provide medical input for regulatory submissions, advisory committee preparation, and local registration activities.
Participate in risk management planning with global and local teams.
6. Scientific & Professional Development
Stay informed on therapeutic area trends, market changes, and competitive landscape.
Provide scientific training to clinical study teams and act as a protocol subject‑matter expert.
Represent the organization at medical congresses and contribute to medical budget planning.
Seek opportunities for external scientific engagement.
7. Leadership & Collaboration
Set and pursue professional development goals and support growth of colleagues and direct reports.
Contribute to recruitment, diversity, and retention efforts when applicable.
Participate in committees, Six Sigma initiatives, and cross‑functional projects.
Model leadership behaviors and serve as an ambassador for patients and the company.
Basic Qualifications
An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 10 years experience and at least 1 year of gastroenterology pharmaceutical experience
Additional Preferences
Clear evidence and documentation of candidate's direct role and contribution to medical content. This should include evidence of candidate as medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical content = medical, scientific or clinical information)
Ability to balance scientific priorities with business priorities with examples of successful leadership skills
Demonstrate strong communication, interpersonal, teamwork, organizational and negotiation skills
Demonstrate ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.
Fluent in English, verbal and written communication
Primary internal interactions include, but not limited to:
Therapeutic area directors, managers, or project managers
Product directors, managers, and associates of the brand
Clinicalresearch staff
Statisticians
Scientific communication associates
Medical information associates
Medical liaisons
Global patient outcomes research consultants/research scientists and health outcomes liaisons
Regulatory directors, scientists, and associates
Sales representatives
Legal counsel
Therapeutic area physicians, global brand physicians, early phase physicians, clinicalresearch scientists, and Regional Medical Leader, Directors-Medical.
Corporate or regional patient safety physician(s)
External Contacts
Scientific and clinical experts, thought leaders
Lilly clinical investigators
Practicing physicians/prescribers
Regulatory agency personnel
Professional association staff and leaders
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$177,000 - $308,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$177k-308k yearly Auto-Apply 7d ago
Director - Clinical Research Scientist
Lilly 4.3
Clinical research coordinator job in Indianapolis, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
**Organization Overview:**
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
**Position Summary:**
The Development ClinicalResearch Scientist will contribute to the oversight of clinical development program(s) in support of overall clinical development strategy and vision and serve as liaison and resource to various physicians and clinical trial sites, drawing on strong medical and scientific knowledge/principles, understanding compliance and regulatory requirements as well as awareness across business operations, and emerging issues.
**Roles and Responsibilities of the Position:**
Core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. The ClinicalResearch Scientist will apply scientific and clinical training and expertise to described roles.
+ Primary responsibility will be supporting the build, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts and other program documents.
+ Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
+ Reporting of adverse events as mandated by corporate patient safety.
+ Engage inclinical development contributions to due diligence or other business development activity. Contributes, as required by program needs and in collaboration with research colleagues, to design and implement translational strategies.
+ Acts in parallel with the clinical lead to solicit opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
+ Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. The CRS serves as a scientific resource for study teams, departments, and others as needed.
+ Responsible for understanding the regulatory requirements related to clinical studies and global drug development and accountable for aligning with those requirements. Become a clinical representative for key regulatory discussions.
**Minimum Requirements:**
+ An advanced health/medical/scientific degree (such as DVM, PharmD, PhD, or MSN with advanced clinical specialty).
+ 1+ years Clinical Trials/Research experience in pharmaceutical industry, academia, research setting with a strong preference for experience within in Oncology and/or Hematology.
**Additional Preferences:**
+ Breast cancer disease area knowledge.
+ Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors.
+ Strong analytical mind and problem-solving skills, thoughtful detail, strong organizational skills, and ability to work independently within a team.
+ Proven track record to bring out the best in others on a cross-functional international team. Leading by influence.
+ Proven track record to interact externally and internally to support a global scientific and business strategy.
+ Strong documentation and leadership qualities, including proficiency with MS Word, EndNote, PowerPoint and Excel.
+ Show one's true mettle to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
+ Strong communication, both written and oral.
+ Ability to multi-task and shift priorities rapidly to meet target dates.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $259,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
\#WeAreLilly
$73k-118k yearly est. 5d ago
Clinical Research Manager
Pharmavise Corporation
Clinical research coordinator job in Indianapolis, IN
Job Description
.
The ClinicalResearch Manager (CRM) is responsible for the strategic and operational oversight of clinical trials conducted across various phases. This role ensures that studies are executed in compliance with regulatory requirements, GCP/ICH guidelines, and internal SOPs. The CRM manages cross-functional teams, monitors timelines and budgets, and acts as the primary liaison between investigators, CROs, vendors, and internal stakeholders.
Key Responsibilities:
Lead the planning, execution, and management of clinical trials across multiple therapeutic areas and phases.
Oversee site selection, study start-up, patient recruitment, data collection, and close-out activities.
Ensure compliance with FDA, ICH-GCP, and other applicable regulatory standards.
Develop and maintain project timelines, budgets, and resource plans.
Supervise and mentor ClinicalResearch Associates (CRAs), Clinical Trial Assistants (CTAs), and study coordinators.
Review and approve study documentation including protocols, CRFs, informed consent forms, and monitoring reports.
Coordinate with cross-functional teams including regulatory affairs, data management, biostatistics, and medical writing.
Manage vendor and CRO relationships, including contract negotiations and performance monitoring.
Track and report on study metrics and provide regular updates to senior leadership.
Oversee the preparation and conduct of audits and regulatory inspections.
Minimum Qualifications:
Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field (Master's or Ph.D. preferred).
Minimum of 5-7 years of experience inclinicalresearch, including 2+ years in a managerial or supervisory role.
In-depth knowledge of clinical trial processes, ICH-GCP guidelines, and regulatory requirements.
Proven experience managing Phase I-IV trials across multiple therapeutic areas.
Strong project management, leadership, and team coordination skills.
Excellent written and verbal communication abilities.
Proficiency with clinical trial software (e.g., CTMS, EDC, eTMF platforms).
Ability to travel up to 20% as needed.
In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well-being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work-life balance while providing the necessary support for professional and personal growth.
Be part of our network of Subject Matter Experts.
E-Verify Participation:
Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at ************ or through their website at dhs.gov/e-verify.
$65k-100k yearly est. 2d ago
Clinical Research Coordinator II
Care Access 4.3
Clinical research coordinator job in Indianapolis, IN
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like
Future of Medicine
, which makes advanced health screenings and research opportunities accessible to communities worldwide, and
Difference Makers
, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinicalresearch and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit *******************
How This Role Makes a Difference
The ClinicalResearchCoordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinicalresearch study subjects while ensuring protocol and regulatory compliance.
How You'll Make An Impact
Duties include but not limited to:
Ability to understand and follow institutional SOPs.
Review and assess protocol (including amendments) for clarity, logistical feasibility
Ensure that all training and study requirements are met prior to trial conduct.
Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.
Assist with planning and creation of appropriate recruitment materials
Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.
Actively work with recruitment team in calling and recruiting subjects
Attend Investigator meetings as required.
Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
Assist in the creation and review of source documents.
Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
Study Management
Prioritize activities with specific regard to protocol timelines
Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
Maintain effective relationships with study participants and other care Access Research personnel.
Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.
Communicate clearly verbally and in writing.
Patient Coordination
Prescreen study candidates
Obtain informed consent per Care Access Research SOP
Complete visit procedures in accordance with protocol.
Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.
Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
Documentation
Record data legibly and enter in real time on paper or e-source documents
Accurately record study medication inventory, medication dispensation, and patient compliance.
Resolve data management queries and correct source data within sponsor provided timelines
Assist regulatory personnel with completion and filing of regulatory documents.
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
The Expertise Required
Excellent working knowledge of medical and research terminology
Excellent working knowledge of federal regulations, good clinical practices (GCP)
Ability to communicate and work effectively with a diverse team of professionals.
Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail
Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.
Critical thinker and problem solver
Friendly, outgoing personality; maintain a positive attitude under pressure.
High level of self-motivation and energy
Excellent professional writing and communication skills
Ability to work independently in a fast-paced environment with minimal supervision.
Certifications/Licenses, Education, and Experience:
Bachelor's Degree preferred, or equivalent combination of education, training and experience.
A minimum of 3 years prior ClinicalResearchCoordinator experience required
Prefer 1 year of experience as a Care Access ResearchClinicalResearchCoordinator
Recent phlebotomy experience required
Bilingual in Spanish-preferred
How We Work Together
Location: This is an on-site position with regional commute requirements. Position requires onsite work 5 days per week at the Indianapolis, INclinic.
Travel: Regularly planned travel within the region will be required as part of the role.
Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members.
Benefits & Perks (US Full Time Employees)
Paid Time Off (PTO) and Company Paid Holidays
100% Employer paid medical, dental, and vision insurance plan options
Health Savings Account and Flexible Spending Accounts
Bi-weekly HSA employer contribution
Company paid Short-Term Disability and Long-Term Disability
401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
$60k-90k yearly Auto-Apply 9d ago
Research Nurse Coordinator
Indiana Hemophilia & Thrombosis Center 4.3
Clinical research coordinator job in Indianapolis, IN
About IHI
At Innovative Hematology, Inc. (IHI), we offer a future where people with rare blood disorders flourish. Our experts provide the highest quality comprehensive services and holistic care to patients with bleeding, clotting and other hematologic disorders, and to their families.
What You Will Do
As a Research Nurse Coordinator, you will be responsible for executing research projects under the direction of the primary investigator and for performing in accordance to study regulatory processes, standard operating procedures, and study protocols.
The Opportunity
Participate in the planning and execution of research projects under the direction of the Medical Director and the primary investigator.
Function as an integral part of the research and comprehensive care teams, working with colleagues to meet deadlines and maintain a flexible schedule based on the needs of patients, the department, and IHI.
Create a study budget in InfoED in collaboration with the finance department. Work with the finance department to assist with billing, invoicing, tracking status on payments due or past due, documenting patient stipend requests, and charting completed study visits.
Assess patients for inclusion and exclusion criteria to determine study eligibility, and work cooperatively with the comprehensive team to coordinate study-related patient care. Explain informed consent for each study participant; document refusals according to protocol.
Ensure accurate and prompt communication with patients, the primary investigator, research manager, external contacts, study sponsors, and monitors.
Prepare study-related documentation such as protocol worksheets, procedural manuals, drug dispensation records, regulatory forms, adverse event reports; submit all relevant study documents to the institutional review board.
Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices. Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
Participate in internal quality assurance; review monitor reports for trends across studies.
Requirements
Minimum Associate's degree in Nursing. Bachelor's preferred
RN or LPN license in the state of Indiana required
Minimum 5 years of related experience
Experience in pharmaceutical sponsored studies required
Valid Indiana Driver's license and automobile insurance
All IHI employees are expected to enable multi-factor authentication via their personal smart phone/smart device in order to access IHI systems as a requirement of the role
Benefits
IHI is a not-for-profit program based inIndianapolis and offers a competitive salary and benefit package.
IHI is the only federally designated comprehensive hemophilia program inIndiana and serves the entire state through services available inIndianapolis and at outreach clinics.
IHI is a leader in hemophilia care, education and clinicalresearch and has a dedicated on-site multidisciplinary staff to ensure availability of a wide range of required services.
IHI participates in national and international clinicalresearch, including new infusion products and therapies, investigation of long-term outcomes, and the impact of associated conditions. The IHI research program provides patients access to new therapies, and an opportunity to improve care. Our center has more than 50 clinicalresearch projects involving bleeding disorders, sickle cell disease, thrombosis and more.
Innovative Hematology, Inc. is an Equal Opportunity Employer.
$53k-74k yearly est. Auto-Apply 60d+ ago
Research Nurse Coordinator
Innovative Hematology, Inc.
Clinical research coordinator job in Indianapolis, IN
Job Description
About IHI
At Innovative Hematology, Inc. (IHI), we offer a future where people with rare blood disorders flourish. Our experts provide the highest quality comprehensive services and holistic care to patients with bleeding, clotting and other hematologic disorders, and to their families.
What You Will Do
As a Research Nurse Coordinator, you will be responsible for executing research projects under the direction of the primary investigator and for performing in accordance to study regulatory processes, standard operating procedures, and study protocols.
The Opportunity
Participate in the planning and execution of research projects under the direction of the Medical Director and the primary investigator.
Function as an integral part of the research and comprehensive care teams, working with colleagues to meet deadlines and maintain a flexible schedule based on the needs of patients, the department, and IHI.
Create a study budget in InfoED in collaboration with the finance department. Work with the finance department to assist with billing, invoicing, tracking status on payments due or past due, documenting patient stipend requests, and charting completed study visits.
Assess patients for inclusion and exclusion criteria to determine study eligibility, and work cooperatively with the comprehensive team to coordinate study-related patient care. Explain informed consent for each study participant; document refusals according to protocol.
Ensure accurate and prompt communication with patients, the primary investigator, research manager, external contacts, study sponsors, and monitors.
Prepare study-related documentation such as protocol worksheets, procedural manuals, drug dispensation records, regulatory forms, adverse event reports; submit all relevant study documents to the institutional review board.
Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices. Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
Participate in internal quality assurance; review monitor reports for trends across studies.
Requirements
Minimum Associate's degree in Nursing. Bachelor's preferred
RN or LPN license in the state of Indiana required
Minimum 5 years of related experience
Experience in pharmaceutical sponsored studies required
Valid Indiana Driver's license and automobile insurance
All IHI employees are expected to enable multi-factor authentication via their personal smart phone/smart device in order to access IHI systems as a requirement of the role
Benefits
IHI is a not-for-profit program based inIndianapolis and offers a competitive salary and benefit package.
IHI is the only federally designated comprehensive hemophilia program inIndiana and serves the entire state through services available inIndianapolis and at outreach clinics.
IHI is a leader in hemophilia care, education and clinicalresearch and has a dedicated on-site multidisciplinary staff to ensure availability of a wide range of required services.
IHI participates in national and international clinicalresearch, including new infusion products and therapies, investigation of long-term outcomes, and the impact of associated conditions. The IHI research program provides patients access to new therapies, and an opportunity to improve care. Our center has more than 50 clinicalresearch projects involving bleeding disorders, sickle cell disease, thrombosis and more.
Innovative Hematology, Inc. is an Equal Opportunity Employer.
$43k-62k yearly est. 22d ago
Full-Time Dialysis Clinical Coordinator
Rendevor Dialysis
Clinical research coordinator job in Plainfield, IN
Who is Rendevor Dialysis?
We are a family-owned and operated company founded over 30 years ago by a Dialysis RN who believes everyone is entitled to excellent medical treatment from talented clinicians.
Our Mission
To bring thriving onsite dialysis partnerships to any under-serviced healthcare institution in need.
What s In It For You?
Our company offers a competitive total rewards package above industry standards in most markets and we pride ourselves in providing a caring, positive culture for our employees.
We offer an extremely generous package including:
Hourly Rate: $62.00 - $65.00/Per Hour (Based on Documented Experience, Qualifications and Market Data)
Fantastic employee benefit package
Employer contribution to H.S.A.
F.S.A. tax savings benefits
A 4% dollar-for-dollar company match to the 401k plan with immediate vesting
A generous PTO accrual program
A PTO cash-out provision
Tuition reimbursement program
Employee referral bonus program
Robust employee recognition and appreciation program
Quality employee training and development programs
Several holidays paid at time and a half
Annual holiday gift bags for all employees
Comprehensive Medical Benefits
Vision
Dental
STD/LTD/Voluntary Life
Accident, Critical Illness and Hospital Indemnity Plans
Pet Insurance
Discounted auto and home insurance
Discounted legal services program
Employer-paid life insurance for 1x employee salary
Employer-paid assistance program with complimentary counseling, wellness, and legal sessions for employees and household members
Complimentary year-long weight loss program
Health & Wellness Program with gift card giveaways
What You ll Do:
The ClinicalCoordinator (CC) is responsible for all overall operations and activities of the smaller-sized dialysis units operated by Rendevor Dialysis. Through effective leadership, professionalism, and management, the ClinicalCoordinator uses clinical/nursing knowledge and dialysis experience to ensure quality measures are met by delivering safe dialysis treatments.
The ClinicalCoordinator develops, trains, coaches, acts as a resource and oversees clinical teammates assigned to the unit as well ass coordinates activities with the technical personnel.
The ClinicalCoordinator provides excellent customer service and maintains strong relationships through effective communication and visibility with providers, DOC/BOP, Managed Healthcare Organization, Post Acute, Hospitals, etc.
As required by the Regional Director, the ClinicalCoordinator is responsible for financial management such as inventory/supplies, accurate staffing efficiencies and ensuring compliance with applicable company and state regulatory requirements.
Reports to the Regional Director as assigned.
This dialysis unit is located in:
Plainfield, IN, within Plainfield Correctional Facility
This dialysis unit operates:
Monday - Saturday from 5:00 am - 4:30 pm
you will also cover the following dialysis unit located in:
This dialysis unit is located in:
Indianapolis, IN within Marion County Jail
This dialysis unit operates:
Operates Monday/Wednesday/Friday (shift depends on the number patients)
As in any setting, this involves teamwork and coordinating care with the healthcare team. In addition to the healthcare team, you are also required to maintain strong relationships, regular communication, and visibility with clients (site Managed Healthcare, DOC/BOP, etc.)
Minimum Qualifications
Education and Experience
Graduation from an Accredited Nursing School or Equivalent
Current RN License for Indiana & current CPR certification (or within three months of hire)
One year of Hemodialysis RN experience is required
Previous management experience preferred
Required Skills and Competencies
Ability to read, write, speak, understand and satisfactorily communicate in English.
Strong technical/computer proficiency with laptops, tablets, Outlook, Excel, PowerPoint, Word, SharePoint, etc.
Ability to quickly learn a variety of technical systems and equipment
Essential Duties and Responsibilities:
Leadership
In conjunction with Regional Director, ensures that dialysis unit operates in compliance with all HIPAA, OSHA, ESRD, state and federal regulations, as well as company policies and procedures.
Leads, coaches, and guides other clinical teammates, depending on unit size.
May be required to monitor clinical teammate in-servicing and skills checks.
Delegates tasks as necessary to maximize time and efficiency.
Holds team huddles to discuss unit goals and objectives and delivers pertinent corporate communication.
Ensures company policies and procedures are maintained for continuity across the company.
Utilizes a variety of systems (MPulse, EMR, ADP, HCP, Equipment, etc.) and ensures compliance of the team.
Participates in onboarding, training, and educating new hires.
Ensures teammates have been properly in-serviced and checked off on skills.
Staffing
Manages staff scheduling and assignments to maintain appropriate patient to staffing ratios. This includes approving and/or denying PTO requests, sending teammates home for low patient census, managing overtime, etc.
Maintains contact with PRN bench staff, coordinating requirements for needed schedules
Facilitates staff development, training, and monthly education.
Is responsible to ensure all clinical teammates maintain license and/or certifications, and do not operate in unit if lapsed.
Participates in employee appreciation events and planning, based on provided budget from Regional Director.
Incoordination with Regional Director, may need to be involved with teammate corrective action plans and annual evaluations of teammates.
Communicates staffing needs with RD and Talent Partner.
Depending on unit size, may be required to participate in interviews and candidate selection.
Encourages employee referrals and may be asked to contact referrals provided by staff.
Clinical
Delivers safe and effective patient care of all treatment modalities
Models thorough and accurate documentation in accordance with industry/client requirements and regulations and holds teammates to same high standards.
Actively participates in patient education, and ensures teammates follow same protocols.
Takes ownership of lab collections and documentation.
Applies critical thinking and time management skills.
Utilizes resources to develop and improve skills, and to monitor quality control measures ensuring continuous quality of patient care.
Depending on unit size and requirements, may be involved with patient care review meetings.
Completion of monthly facility audits (using an audit template provided by the RD). Develops action plans to address any deficiencies.
Acts as on-site liaison to the corporate biomedical team and timely notifies biomedical technician via MPulse of any service request.
Takes ownership of unit safety, cleanliness, and infection control
As appropriate, lobbies with client administration to eliminate any restrictions that may negatively impact patient outcomes, such as infection rate, catheter utilization, AMA rate, refusal rate, etc.
Monitors and assures that the patients receive adequate medical attention while in the dialysis unit.
Maintains the integrity of all protected health information.
Knows and follows policies and procedures of the DOC and Rendevor Dialysis, and monitors staff compliance of same.
Supervises medical records to ensure complete documentation.
Engages in constant learning and research of dialysis practices.
Continuous Quality Improvement/Quality Assurance & Performance Improvemen
Collaborates with the Clinical Services team to meet CQI/QAPI initiatives, clinical goals, and patient outcomes as needed.
Assists or may be responsible for the monthly completion of the Rendevor Application requirements.
Ensures adequate resources for supporting the CQI/QAPI process as applicable.
Communication (internal and external)
Maintains open communication with facility personnel, Managed Care group, providers, Rendevor management team, biomedical team, staff, etc.
May be required to attend and participate in facility meetings.
Checks email daily and responds appropriately and timely; uses company-provided email for all work-related email communications.
Maintains an open-door policy to communicate with teammates.
Maintains professionalism and privacy of confident information.
Payroll
Records both arrival and departure time via ADP s time and attendance system, following the guidelines outlined by Human Resources.
Assists new hires in accessing the time system and demonstrates proper log in/out procedures.
If assigned, approves timesheets of unit teammates in ADP.
Accounting
Timely and accurate review and submission of treatment rosters within two days of month end.
Inventory/Supplies
Accurate and timely submission of unit supply orders to the RAA and RD per the unit schedule.
Responsible for ensuring the unit has adequate supply inventories on hand, that no supplies are expired, and that emergency supply levels are understood/on-hand.
Communicates and coordinates a-typical supply ordering with RD/RAA and purchasing department.
Business Development
Works diligently to be a great on-site partner to our client and be a company advocate to all outside parties.
Actively listens for new opportunities within dialysis industry and sends any potential leads to supervisor.
General
Promotes and implements the Company s mission, vision, and core values.
Displays excellent and professional written/verbal communication skills.
Always maintains a professional demeanor; keeps an open door policy.
Operates with a high level of responsiveness in providing information and deliverables to supervisors.
Demonstrates a high degree of self-motivation and willingness to improve.
Openly receives and promptly acts upon any feedback from supervisors, peers, clients.
Volunteers to assist colleagues when necessary and assist with various projects as assigned.
Reports any incidents to Regional Director.
Reports work-related injuries to carrier via web portal. Follows up with HR and RD. Collects statement from claimant as well as witness statements.
Must maintain RN license, CPR and a clean background.
Checks company email each working day and responds timely and appropriately; uses company-provided email for all work-related email communications.
Adheres to all company and departmental policies and procedures.
Maintains regular and predictable attendance and punctuality.
Other duties as assigned.
Supervision:
This position will report to the Regional Director.
This position will supervise clinical team members.
Background Check:
The Department of Corrections/Federal Bureau of Prisons and all applicable law require a comprehensive background check for all employees working in this position. This background check will be conducted after an offer, if any, is made.
Work Environment:
This role exists in a hospital, training center, patient residence, or in the medical unit of a post-acute or correctional facility. This role may include exposure to chemicals and blood-borne pathogens. This role routinely involves the use of both medical and standard office equipment. This position cannot be performed remotely.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk and hear. To perform the essential functions of this job, the employee is required to continually stand, and frequently bend, walk, twist, crouch, use hands to handle or feel, and reach with hands and arms. This position requires the ability to push, pull, and lift up to 50 pounds. Specific visual abilities required by this job include close vision and ability to adjust focus. The employee is required to work the full schedule which may range from five to fifteen hours per day, based on the unit requirements (i.e. patient census, staffing needs, etc.)
Rendevor Dialysis is an Equal-Opportunity Employer.
$44k-63k yearly est. 29d ago
Director - Clinical Research Scientist
Eli Lilly and Company 4.6
Clinical research coordinator job in Indianapolis, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Summary:
The Development ClinicalResearch Scientist will contribute to the oversight of clinical development program(s) in support of overall clinical development strategy and vision and serve as liaison and resource to various physicians and clinical trial sites, drawing on strong medical and scientific knowledge/principles, understanding compliance and regulatory requirements as well as awareness across business operations, and emerging issues.
Roles and Responsibilities of the Position:
Core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. The ClinicalResearch Scientist will apply scientific and clinical training and expertise to described roles.
Primary responsibility will be supporting the build, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts and other program documents.
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Reporting of adverse events as mandated by corporate patient safety.
Engage inclinical development contributions to due diligence or other business development activity. Contributes, as required by program needs and in collaboration with research colleagues, to design and implement translational strategies.
Acts in parallel with the clinical lead to solicit opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. The CRS serves as a scientific resource for study teams, departments, and others as needed.
Responsible for understanding the regulatory requirements related to clinical studies and global drug development and accountable for aligning with those requirements. Become a clinical representative for key regulatory discussions.
Minimum Requirements:
An advanced health/medical/scientific degree (such as DVM, PharmD, PhD, or MSN with advanced clinical specialty).
1+ years Clinical Trials/Research experience in pharmaceutical industry, academia, research setting with a strong preference for experience within in Oncology and/or Hematology.
Additional Preferences:
Breast cancer disease area knowledge.
Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors.
Strong analytical mind and problem-solving skills, thoughtful detail, strong organizational skills, and ability to work independently within a team.
Proven track record to bring out the best in others on a cross-functional international team. Leading by influence.
Proven track record to interact externally and internally to support a global scientific and business strategy.
Strong documentation and leadership qualities, including proficiency with MS Word, EndNote, PowerPoint and Excel.
Show one's true mettle to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
Strong communication, both written and oral.
Ability to multi-task and shift priorities rapidly to meet target dates.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $259,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$151.5k-259.6k yearly Auto-Apply 6d ago
Learn more about clinical research coordinator jobs
How much does a clinical research coordinator earn in Indianapolis, IN?
The average clinical research coordinator in Indianapolis, IN earns between $33,000 and $70,000 annually. This compares to the national average clinical research coordinator range of $37,000 to $72,000.
Average clinical research coordinator salary in Indianapolis, IN
$48,000
What are the biggest employers of Clinical Research Coordinators in Indianapolis, IN?
The biggest employers of Clinical Research Coordinators in Indianapolis, IN are: