Clinical research coordinator jobs in Noblesville, IN - 70 jobs
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Director - Clinical Research Scientist - Global and US Medical Affairs
Eli Lilly and Company 4.6
Clinical research coordinator job in Gas City, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, 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 5d ago
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Senior Clinical Research Associate (FSP) - Central Region - Oncology
Thermofisher Scientific 4.6
Clinical research coordinator job in Indianapolis, IN
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinicalresearch through our PPD clinicalresearch portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Essential Functions and Other Job Information:**
**Essential Functions**
+ Monitors investigator sites with a risk-based monitoring approach: applies root Functions cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
+ Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.
+ Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.
+ Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
+ Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).
+ Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
+ Responds to company, client and applicable regulatory requirements/audits/inspections.
+ Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
+ Contributes to other project work and initiatives for process improvement, as required.
**Qualifications:**
**Education and Experience:**
Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as traveling clinicalresearch associate). Valid driver's license where applicable.
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
**Knowledge, Skills and Abilities:**
+ Effective clinical monitoring skills
+ Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
+ Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents
+ Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
+ Ability to manages Risk Based Monitoring concepts and processes
+ Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
+ Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
+ Effective interpersonal skills
+ Strong attention to detail
+ Effective organizational and time management skills
+ Ability to remain flexible and adaptable in a wide range of scenarios
+ Ability to work in a team or independently as required
+ Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
+ Good English language and grammar skills
+ Good presentation skills
**Compensation and Benefits**
The salary range estimated for this position based in Illinois is $79,200.00-$136,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
+ A choice of national medical and dental plans, and a national vision plan, including health incentive programs
+ Employee assistance and family support programs, including commuter benefits and tuition reimbursement
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
+ Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: *****************************************************
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
$79.2k-136k yearly 28d ago
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 Scientist
Eliassen Group 4.7
Clinical research coordinator job in Indianapolis, IN
**Anywhere** **Type:** Permanent **Category:** Clinical Ops **Industry:** Life Sciences **Workplace Type:** Remote **Reference ID:** JN -112025-104407 **Shortcut:** ********************************** + Description + Recommended Jobs
**Description:**
_Remote_
Our client is a PE-backed medical device organization advancing next-generation technologies in atrial fibrillation and cardiac ablation. As the team prepares for two global Class III IDE studies, the Clinical Development and Science function is expanding to support protocol development, safety oversight, and scientific leadership. The role provides exposure to electrophysiology and Pulse Field Ablation, contributing to the scientific, clinical, and strategic elements of cardiac ablation innovation.
_This is a full-time, permanent opportunity, offering a competitive salary and comprehensive benefits package. Qualified applicants must be willing and able to work on a w2 basis._
Salary: $130,000 - $150,000/ yr. w2
**Responsibilities:**
**Responsibilities**
+ Lead development of clinical study protocols, case report forms, and associated study documents.
+ Support clinical safety oversight, including adverse event review, vigilance, and coordination with the Clinical Events Committee.
+ Contribute scientific input into study design, endpoints, and overall clinical strategy.
+ Review and interpret clinical data to support study reports, publications, and regulatory submissions.
+ Collaborate closely with Clinical Operations, Field Clinical, Regulatory, and Quality teams.
+ Participate in discussions with key opinion leaders, investigator meetings, and internal scientific reviews.
+ Ensure scientific consistency across programs and alignment with regulatory and clinical goals.
+ Support the development of data collection tools and ensure clarity, accuracy, and completeness.
+ Assist with medical writing elements related to clinical reports and study documentation.
**Experience Requirements:**
**Experience Requirements**
+ Electrophysiology and Pulse Field Ablation experience required.
+ Background supporting clinical studies in industry or academia.
+ Strong understanding of clinicalresearch methods and safety reporting.
+ Ability to evaluate and interpret clinical data.
+ Strong scientific writing skills and attention to detail.
+ Ability to collaborate effectively across Clinical Development, Operations, and Regulatory functions.
+ Excellent communication and analytical capabilities.
+ Prior experience as a Clinical Scientist in medical devices preferred.
+ Experience with Class III devices or IDE studies preferred.
+ Experience contributing to regulatory submissions or interacting with health authorities preferred.
+ Experience working with electrophysiologists, key opinion leaders, or clinical event committees preferred.
**Education Requirements:**
**Education Requirements**
+ MS, PhD, or MD.
**_Recruitment Transparency Notice_**
**_Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (_** **_noreply@eliassen.com_** **_, ************* inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process._**
_Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range._
_W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality._
_Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact_ _********************_ _._
_About Eliassen Group:_
_Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate._
_Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status._
_Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!_
$130k-150k yearly 6d ago
Divisional Government Grants and Research Coordinator (DHQ)
Salvation Army USA 4.0
Clinical research coordinator job in Indianapolis, IN
The Salvation Army Mission Statement: The Salvation Army, an international movement, is an evangelical part of the universal Christian church. Its message is based on the Bible. Its ministry is motivated by the love of God. Its mission is to preach the gospel of Jesus Christ and to meet human needs in His name without discrimination.
Salary Range Starting at: $65,000.00 annually
:
As the Divisional Government Grants and ResearchCoordinator, you will be responsible for researching federal, state, and local government funding opportunities and preparing high-quality grant proposals to secure funding for organizational programs and initiatives. This role requires exceptional writing skills, strong attention to detail, and the ability to interpret government guidelines, compliance requirements, and program regulations; advising program staff and Corps officers about grant requirements and expectations; to ensure comprehensive coordination of grant-related support for Programs, Corps and Service Extension Units across the Indiana Division, so that the mission of The Salvation Army is effectively carried out.
What You Will Do:
* Research federal, state, and local grant opportunities through government portals (such as Grants.gov, SAM.gov, and state/local portals).
* Identify grants that align with organizational mission, programs, and strategic objectives.
* Track application deadlines, eligibility requirements, and submission protocols.
* Write, format, and edit government grant applications, narratives, and supporting documents.
* Ensure proposals comply with government requirements, including formatting, data reporting, and regulatory standards.
* Participate in budget development with finance teams to create compliant, realistic, and funder-aligned budgets.
* Prepare all required attachments, certifications, and supplemental materials.
* Work with directors, program managers, and financial staff to align proposals with organizational capacity and goals.
* Support planning meetings and grant strategy sessions.
* Communicate grant requirements, timelines, and responsibilities to internal teams.
* Provide support as needed to Corps officers and staff in writing and/or proofreading their grant proposals
* Ensure grant applications are approved by Divisional Finance Board and grant agreements are signed by DFB leadership
* Maintain calendar of grant application and reporting deadlines to ensure timeliness and effective utilization of funding opportunities
* Other tasks as assigned by leadership
Minimum Qualifications: The requirements listed below are representative of the minimal education, experience, skills, and/or abilities required for this position.
Education: Bachelor's degree in social work, public administration, nonprofit management, or other closely related fields from an accredited institution.
Background Checks: Position requires a background check to be completed, and all background check results will be reviewed.
Experience: A minimum of three years' grant writing experience in a nonprofit environment, including demonstrated success in managing and coordinating grant writing projects, securing grant awards, and completing timely grant reports.
Certifications: Must have a valid driver's license and maintain The Salvation Army Driver's qualification standard; must complete Safe from Harm training within the first 90 days of employment.
Skills/Abilities:
* Excellent writing, verbal communication, time management, and organizational skills.
* Able to speak, write and understand English in a manner sufficient for effective communication with leadership, field personnel, and funders.
* Computer proficiency with Microsoft products and ability to learn electronic reporting systems.
* Strong understanding of federal, state, and local government funding processes.
* Excellent research, writing, and editing skills with superior attention to detail.
* Ability to interpret government regulations, RFPs, and funding guidelines.
* Experience with logic models, program design, and outcome measurement.
Supervisory Responsibility: None
The physical requirements described here are representative of those that must be met by an employee to successfully perform the duties of this job. Reasonable accommodation may be provided to enable individuals to perform the essential functions of this job.
Physical Requirements Include:
* Good speaking, hearing and vision ability, and excellent manual dexterity
* Lifting, pulling, and pushing of materials up to 25 pounds
* May require bending, squatting, walking.
* May require standing for extended
Travel: Occasional travel may be needed to meet with funders, attend meetings, and visit TSA facilities in the Division.
Working Conditions: Work is performed in an office environment. May require occasional weekend or evening work.
All employees recognize that The Salvation Army is a church and agree that they will do nothing as an employee of The Salvation Army to undermine its religious mission.
The Salvation Army is an equal opportunity employer. Candidates who are back-to-work, US Veterans, people with disabilities, people who have been impacted by the justice system, and/or people without a college degree are encouraged to apply.
This job description should not be interpreted as all inclusive. It is intended to identify the essential functions and requirements of the position. Other job-related responsibilities and tasks may be assigned. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential job functions.
Why Work with Us?
If you're ready for a career doing meaningful work with a discernable impact, keep reading. The Salvation Army's brand promise is to Do the Most Good - and it's our employees that help us get there. At every level and in every discipline, you can have a real impact on your community through the work done inside our walls every day. If you work for us, you will be the hands and feet that enable us to help others.
We are as impassioned about our employees as we are about our mission to preach the Gospel of Jesus Christ and help anyone in need in His name without discrimination. Our work culture reflects this quality, which makes our offices seriously great places to work. Just walk inside our doors and you'll quickly see that our employees are proud to support programs that make a difference.
In addition to traditional Health, Wellness, RX and PTO benefits, see what our employees told us they most liked about working for the Indiana Division of TSA by responding to our most recent 2023 survey…
* 91% are proud of their work to help meet the needs of people in their communities
* 75% find their "Work Stress" manageable
* 80% find their managers supportive during those times of stress
* 89% appreciate the flexible work options they have in their position
* 98% appreciate how they are allowed to use 4 sicks days as "Discretionary"
* 99% appreciate the 11 paid holidays they receive each year
See what our employees said when asked to rank the best reasons for working at the Indiana Division Salvation Army…
* Helping People
* Faith Centered Organization
* Work Environment/ Co-Workers
* Benefits
$65k yearly Auto-Apply 28d 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 in Indianapolis, 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
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
Senior Clinical Research Associate/Clinical Research Associate II - Oncology - US - FSP
Parexel 4.5
Clinical research coordinator job in Indianapolis, IN
**Job Purpose:** The Senior ClinicalResearch Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial.
**Key Accountabilities:**
**Oversight of Monitoring Responsibilities and Study Conduct**
+ Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality
+ Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
+ During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
+ Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
+ Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
+ Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and
+ recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
+ Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
+ Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
+ Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
+ Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
+ Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
+ Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities
+ Support database release as needed
+ May undertake the responsibilities of an unblinded monitor where appropriate
**Clinical/Scientific and Site Monitoring Risk**
+ Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
+ Interact with investigator site heath care professionals in a manner which enhances sponsor's credibility, scientific leadership and in order to facilitate sponsor's clinical development goals
+ Support the study clinicianin ensuring patient safety, eligibility and providing clinical guidance to investigators
+ Drive Quality Event (QE) remediation, when applicable
+ Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable
**Collaboration**
+ Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM)
+ Partners with SCP and Country Study Operations Manager (SOM)
+ When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist)
+ May act as a Mentor for ClinicalResearch Associates
**Skills:**
+ Monitoring Experience: Minimum 3 years relevant experience inclinicalresearch site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization
+ Preferred therapeutic experience in Oncology
+ Global clinical trial experience preferred
+ Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
+ Must be fluent in English and in the native language(s) of the country they will work in
+ Travel (60-80%) within area is required
+ Valid driver's license and passport required
**Knowledge and Experience:**
+ Demonstrated knowledge of clinicalresearch and development processes and ability to gain command of process details
+ Demonstrated knowledge of global and local regulatory requirements
+ Demonstrated understanding of key operational elements of clinicalresearch (e.g., monitoring, data acquisition and cleaning, reporting, etc.)
+ Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)
+ Demonstrated ability to support sponsor regulatory interactions/inspections
+ Demonstrated knowledge of the processes around protocol design and feasibility assessment
+ Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery
+ Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial
+ Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation
+ Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
**Education:**
+ Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required
\#LI-CF1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$78k-106k yearly est. 46d 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 Research Coordinator
Community Health Network 4.3
Clinical research coordinator job in Indianapolis, IN
Hours:
Monday-Friday 8\:00 am - 4\:00 pm
Join Community Community Health Network has an excellent opportunity available within our clinicalresearch department. If you are looking for challenging work and meaningful advancement, then you should consider a career with Community.
Make a Difference
The ClinicalResearch Specialist will be responsible for the development and implementation of recruitment strategies and plans for enrolling clinical trials. Responsible for execution of all aspects of the recruitment plan including but not limited to identifying and screening patients. Facilitates evaluation of clinical trials through feasibility reviews and data abstraction.
Your Exceptional Qualifications
Maintains knowledge and understanding of assigned protocols.
Supports the coordinators and investigators in identifying, screening, interviewing, and consenting eligible patients for the clinical trial and completing the associated data entry and source documentation in accordance with protocol guidelines, GCP, ICH, local, state and federal standards
Assists with administrative activities generally associated with the conduct of the clinical trials and support of the department as needed and as trained
Collects, processes and ships specimens per protocol and regulations as needed and as trained
Participates in monitor and regulatory audits and routine department meetings as needed
Performs other tasks, duties, or responsibilities as assigned or needed for the effective, safe, or efficient functioning/operation of the department.
Demonstrates respect for and cooperation with all persons in performing job duties and responsibilities; maintains courteous, complete and confidential communication with all patients, visitors, and other guest
EDUCATION
2 year / Associate Degree (Required)
4 year / Bachelor's Degree (Preferred)
In lieu of the above education requirements, a combination of experience and education will be considered.
LICENSE & CERTIFICATION REQUIREMENTS
within three (3) years from hire Certifications/Licensures\: (Certified ClinicalResearch Associate (CCRA - ACRP), Certified ClinicalResearchCoordinator (CCRC-ACRP), Certified ClinicalResearch Professional (CCRP-SoCRA))
EXPERIENCE
Previous experience in data abstraction is helpful (Preferred)
Minimum of 2 years in a related field of healthcare (Required)
$42k-58k yearly est. Auto-Apply 60d+ 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 in Indianapolis 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 in Indianapolis 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 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
Sr. Research Scientist, Non-Clinical Safety & Toxicology
Elanco 4.9
Clinical research coordinator job in Indianapolis, IN
At Elanco (NYSE: ELAN) - it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better - join our team today!
Your Role: Senior Research Scientist, Non-Clinical Safety & Toxicology
We are seeking an experienced non-clinical toxicology / safety scientist to join the Global Non-Clinical Development team in Global Clinical Development. As the Senior Research Scientist, Non-Clinical Safety & Toxicology you will be responsible for, or will assist with, human (user & consumer) safety and target animal safety program strategy and execution at all phases of global veterinary pharmaceutical drug/product and feed additive research and development, product safety assessments, and support for marketed products.
This role applies toxicology and immunology expertise to assess safety risks across the full product lifecycle, from early development through commercialization. Responsibilities include evaluating potential safety concerns related to product design, manufacturing changes, deviations, or consumer complaints that could impact animal safety or end-user health. The role involves preparing Product Safety Assessments (PSAs) for products in development, production, or on the market, and compiling medical and toxicological data to assess potential health risks for consumers and end users.
Your Responsibilities:
Independently design, organize, monitor, report, and resolve issues related to outsourced
in vitro
and
in vivo
safety/toxicology studies, utilizing external CROs and/or consultants as needed. These studies may involve typical rodent and non-rodent species. Target animal safety evaluations may include companion animals (dogs and cats) as well as food-producing animals (e.g., cattle, pigs, chickens).
Conduct literature reviews and author expert reports, position papers, safety and hazard/risk assessments, and other strategic scientific, technical, or medical evaluations to address safety considerations for veterinary drugs (small molecules and biologics), feed additives, excipients, E&L substances, impurities, or other chemicals.
Provide internal expert guidance, including expert statements, health-based exposure limits (e.g., PDEs, OELs), and target safety assessments.
Engage with regulatory agencies to address safety concerns for both products in development and marketed products, including preparing and submitting documentation and delivering formal presentations.
Collaborate closely with colleagues in Manufacturing, Quality, Human Food Safety, ADME/PK, and Environmental Safety to accomplish multidisciplinary non-clinical objectives for projects and products.
Proactively participate in global, cross-functional project teams (e.g., clinical, pharmaceutical development, regulatory affairs, quality, manufacturing) within a matrix organization to drive project success.
Maintain technical and professional expertise by staying current with scientific developments and sharing relevant insights and best practices within the organization.
What You Need to Succeed (Minimum Qualifications):
Education: DVM and/or PhD (preferred) in toxicology or another relevant biomedical science discipline (e.g., veterinary medicine, biology, chemistry) with at least 5 years of industry experience in non-clinical safety, or a Master's degree with at least 7 years of relevant experience.
Experience: Demonstrated ability to apply toxicology and risk assessment principles aligned with global regulations and guidance. Experience in non-clinical veterinary drug development, including target safety assessments, in silico predictions, and safety evaluations throughout product life cycles. Strong background in large molecule, biologics, vaccine, and antibody development, as well as using in vitro/in vivo data and literature to support product development and registration.
Top 2 skills: A strong, collaborative team-player with expertise in toxicology and immunology with strong risk assessment capabilities. Highly skilled in cross-functional collaboration, regulatory strategy, and effective communication of complex scientific concepts.
What Will Give You a Competitive Edge (Preferred Qualifications):
Board certification as a toxicologist (ERT, DABT, or equivalent).
Immunological background, especially related to monoclonal antibodies and emerging platform technologies for indications like dermatology or pain.
Deep understanding of US, European, and international veterinary drug development, as well as agribusiness practices for companion and farm animals.
Strong working knowledge of GLP regulations and experience with in silico toxicity prediction tools.
Ability to manage complex projects independently, with strong organizational and time management skills.
Excellent written and verbal communication skills in English.
Additional Information:
Travel: Up to 30% annually (domestic and international)
Location: Global Elanco Headquarters - Greenfield, IN - Hybrid Work Environment (Soon to be Indianapolis, Indiana NEW HQ October 2025)
Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Multiple relocation packages
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
$67k-93k yearly est. Auto-Apply 42d ago
RN Oncology Clinical Trial Research Coordinator
Ascension Health 3.3
Clinical research coordinator job in Indianapolis, IN
Details * Department: Research - Oncology * Schedule: Full Time Day - Monday - Friday 8-5 * Hospital: Ascension St. Vincent Benefits Paid time off (PTO) Various health insurance options & wellness plans Retirement benefits including employer match plans
Long-term & short-term disability
Employee assistance programs (EAP)
Parental leave & adoption assistance
Tuition reimbursement
Ways to give back to your community
Benefit options and eligibility vary by position. Compensation varies based on factors including, but not limited to, experience, skills, education, performance, location and salary range at the time of the offer.
Responsibilities
Lead clinicalresearch projects via study protocols and provide direct patient care for study participants.
* Assist with the preparation, submission and management of internal/external compliance documentation at all stages of the research project.
* Assist with the selection, education, testing, and monitoring of research project participants. Follow protocols and collaborate with other healthcare providers to ensure continuity of participant care.
* Document patient care and study results using appropriate formats and systems. Communicate patient/study results on an on-going basis to research team.
* Participate in quality assurance/improvement initiatives. Ensure compliance with applicable standards of care and regulatory requirements.
Requirements
Licensure / Certification / Registration:
* Registered Nurse credentialed from the Indiana Board of Nursing obtained prior to hire date or job transfer date required.
Education:
* Diploma from an accredited school/college of nursing OR Required professional licensure at time of hire.
Additional Preferences
No additional preferences.
Why Join Our Team
Ascension St. Vincent inIndiana has been providing rewarding careers in healthcare for over 148 years. With 24 hospitals throughout the greater Indianapolis and Evansville areas, Ascension St. Vincent offers careers in a wide range of services including acute and long-term care, bariatrics, cancer care, cardiovascular services, emergency services, neuroscience, orthopedics, pediatric services, primary and urgent care, women's health services and more.
Ascension is a leading non-profit, faith-based national health system made up of over 134,000 associates and 2,600 sites of care, including more than 140 hospitals and 40 senior living communities in 19 states.
Our Mission, Vision and Values encompass everything we do at Ascension. Every associate is empowered to give back, volunteer and make a positive impact in their community. Ascension careers are more than jobs; they are opportunities to enhance your life and the lives of the people around you.
Equal Employment Opportunity Employer
Ascension provides Equal Employment Opportunities (EEO) to all associates and applicants for employment without regard to race, color, religion, sex/gender, sexual orientation, gender identity or expression, pregnancy, childbirth, and related medical conditions, lactation, breastfeeding, national origin, citizenship, age, disability, genetic information, veteran status, marital status, all as defined by applicable law, and any other legally protected status or characteristic in accordance with applicable federal, state and local laws.
For further information, view the EEO Know Your Rights (English) poster or EEO Know Your Rights (Spanish) poster.
As a military friendly organization, Ascension promotes career flexibility and offers many benefits to help support the well-being of our military families, spouses, veterans and reservists. Our associates are empowered to apply their military experience and unique perspective to their civilian career with Ascension.
Please note that Ascension will make an offer of employment only to individuals who have applied for a position using our official application. Be on alert for possible fraudulent offers of employment. Ascension will not solicit money or banking information from applicants.
E-Verify Statement
This employer participates in the Electronic Employment Verification Program. Please click the E-Verify link below for more information.
E-Verify
$39k-59k yearly est. Auto-Apply 5d ago
Study Coordinator I - Bioanalytical Lab Operations
Labcorp 4.5
Clinical research coordinator job in Indianapolis, IN
We have an excellent opportunity for a Study Coordinator I on our BioAnalytical Team.
Labcorp Drug Development's work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career.
In this role, you will be coordinating the activities of routine and non-routine studies in compliance with appropriate company standards, GLP, GCP, GMP, and regulatory guidelines specified in the study plans, protocols, or work agreements governing the work in which they are involved in a timely, efficient, and quality manner. High volume of data and report delivery.
Candidates given best consideration will have the following skills/experience:
Proficient in Microsoft Excel and Microsoft Word
Highly Organized
Works Well Independently
Ability to Multi-task Effectively and Navigate Various Systems
Schedule: Core hours are 9:00am-3:00pm with flexibility on start and end times around core hours.
Essential Duties:
Independently drafts protocols, sample analysis outlines (SAOs), amendments and study schedules as appropriate, using proposal outline or client-supplied information.
Reviews study compliance against protocol, SOP, and regulatory agency guidelines.
Learns to serves as the primary contact in communication and interaction with other departments and clients as applicable.
Updates and maintains project tracking systems as appropriate.
Participates in and assists Study Director/Principal Investigator (SD/PI) with pre-initiation and other study related meetings, including scheduling and leading meetings as required.
Learns to manage increasingly complex projects and study designs and/or increased study load.
Responsible for report preparation, including table and figure preparation.
Assists in evaluating data for reports.
Maintains well documented, organized, and up-to-date study files including study schedule, protocol, and correspondence, as applicable.
Reviews QAU report audits and submits audit responses for approval as appropriate.
Reviews client comments and makes decisions, including appropriate study personnel as necessary, to ensure that all necessary report/raw data clarifications are completed.
Responsible for report production through finalization, including archival of data as appropriate.
Assists with routine client visits as requested. Manages data transfer to clients as requested.
Assists SD/PI in monitoring study phases.
Performs other related duties as assigned.
Minimum Required:
Bachelor of Science (BS) degree in science or related field preferred; experience may be substituted for education
Ability to learn/utilize word processing software, database, spreadsheet, and specialized software
Excellent communication and interpersonal skills
Excellent attention to detail
Ability to prioritize, organize, and manage time
Pay Range: $23.00 - $25.00
Application Window: 1/21/26 thru 1/24/26
All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here.
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.
$23-25 hourly Auto-Apply 1d 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 in Indianapolis 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 in Indianapolis 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
Specialist, Clinical Business Operations, Oncology
Sumitomo Pharma 4.6
Clinical research coordinator job in Indianapolis, IN
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
**Job Duties and Responsibilities**
+ Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA).
+ Assist with the entry of Contractual Agreements into an electronic document repository.
+ Ensure all outsourcing decisions are properly documented, compliant, and audit-ready.
+ Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate.
+ Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements.
+ Perform other duties as requested.
**Key Core Competencies**
+ Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities
+ Ability to proactively identify and act on opportunities for operational efficiencies
+ Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude
+ Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution
+ Excellent written and oral communication skills
**Education and Experience**
+ BA/BS preferred with at least 2 years experience, or 5 years equivalent experience
+ Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles.
The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at **********************************************
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
$72.5k-90.6k yearly 60d+ 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. 25d ago
Learn more about clinical research coordinator jobs
How much does a clinical research coordinator earn in Noblesville, IN?
The average clinical research coordinator in Noblesville, IN earns between $34,000 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 Noblesville, IN