Clinical research coordinator jobs in Indiana - 112 jobs
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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Clinical Research Associate 1
Allen Spolden
Clinical research coordinator job in Indiana
Responsible for providing ClinicalResearch support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinicalresearch functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1 -2 years of clinicalresearch experience or equivalent experience or training
Strong attention to detail
Ability to multi -task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self -motivated, assertive, and driven
BenefitsDental, Medical, Vision, PTO and 401K
$53k-84k yearly est. 60d+ 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
Clinical Research Associate (CRA)
Pharmavise Corporation
Clinical research coordinator job in Indianapolis, IN
Job Description
.
We are seeking experienced ClinicalResearch Associates (CRAs) to provide surge capacity support for ongoing clinicalresearch projects. This role focuses on study maintenance and closeout activities, ensuring efficient project execution. The CRA will serve as a primary point of contact for study teams and external partners, supporting essential clinical operations without direct involvement in study startup activities.
Key Responsibilities:
Oversee study-level project management tasks, including study maintenance, data lock, closeout, document review, and budget monitoring.
Act as the primary liaison between internal study teams and external third-party organizations (TPOs).
Track and monitor safety, biomarker, pharmacokinetic (PK), anti-drug antibody (ADA) samples, imaging data, and connected device data.
Manage and track clinical queries to ensure timely resolution.
Collaborate with internal teams to align clinicalresearch processes and operational strategies.
Coordinate with business partners and TPOs to facilitate data delivery and ensure compliance with study requirements.
Minimum Qualifications:
Bachelor's degree in a relevant field.
6+ years of experience inclinicalresearch or a related industry.
Experience as a ClinicalResearch Associate, ClinicalResearchCoordinator, or ClinicalResearch Assistant.
3+ years of experience in project management or a related role.
Prior experience in pharmaceutical, diagnostics, or CRO environments.
Strong organizational skills with attention to detail.
Ability to effectively communicate with diverse stakeholders.
Proficiency in Microsoft Excel for data tracking and reporting.
Experience with clinical trial management tools such as Medidata RAVE, Veeva Vault, Oracle InForm, or similar platforms.
Familiarity with electronic Trial Master File (eTMF) systems, query management tools, and safety reporting databases.
Working knowledge of GCP (Good Clinical Practice) guidelines and regulatory compliance requirements.
In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well-being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work-life balance while providing the necessary support for professional and personal growth.
Be part of our network of Subject Matter Experts.
E-Verify Participation:
Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at ************ or through their website at dhs.gov/e-verify.
$52k-83k yearly est. 4d ago
Clinical Research Scientist - Breast Cancer Franchise
Lilly 4.3
Clinical research coordinator job in Indianapolis, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered 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
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 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
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
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 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
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 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
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
Clinical Research Coordinator
ECN Operating
Clinical research coordinator job in Merrillville, IN
We are seeking a highly organized and motivated ClinicalResearchCoordinator (CRC) to join our research team. The CRC will coordinate and support all aspects of clinical trials and research studies, including subject recruitment, data collection, regulatory compliance, and specimen handling. Candidates with current Phlebotomy certification or Medical Assistant (MA) certification are strongly preferred, as this role may include specimen collection and basic clinical procedures.
Key Responsibilities:
Coordinate day-to-day clinicalresearch activities to ensure study protocols are followed.
Recruit, screen, and enroll study participants.
Obtain informed consent and ensure ethical conduct in all study interactions.
Collect, process, and ship biological specimens per protocol (e.g., blood draws, urine samples).
Perform basic clinical procedures as permitted by certification (e.g., vital signs, EKGs).
Maintain accurate and timely documentation in case report forms and electronic databases.
Communicate with sponsors, monitors, and IRBs regarding study progress and compliance.
Schedule participant visits and follow-ups; ensure visit windows are met.
Ensure proper storage, handling, and accountability of investigational products, if applicable.
Maintain regulatory documents and assist with IRB submissions.
Qualifications:
Bachelor's degree in a health-related field required.
At least 1 2 years of experience inclinicalresearch preferred.
Phlebotomy certification or MA certification preferred.
Knowledge of Good Clinical Practice (GCP) and regulatory guidelines.
Excellent organizational skills and attention to detail.
Strong interpersonal and communication skills.
Proficiency in Microsoft Office and electronic data capture systems (e.g., REDCap, EDC platforms).
Ability to work independently and as part of a multidisciplinary team.
Preferred Qualifications:
Experience working inclinical trials, especially in a hospital or academic setting.
Familiarity with IRB processes and clinical trial documentation.
Bilingual skills (depending on patient population) may be a plus.
Job Type: Full-time
Work Location: In person
Schedule:
8 hour shift
Monday to Friday
Weekends as needed
$40k-59k yearly est. 14d ago
Clinical Research Coordinator I
Objectivehealth 3.7
Clinical research coordinator job in South Bend, IN
Our clinicalresearch company is looking to hire a qualified candidate for the full-time position of ClinicalResearchCoordinator. The ideal candidate will possess certification such as an MA, phlebotomy, or similar and have a strong desire to work directly with patients.
Who We Are
ObjectiveHealth is a clinicalresearch company that uses proprietary technology to:
Increase patient access to research trials within our communities,
Provide physicians with enhanced care options for current patients, and
Deliver superior clinicalresearch enrollment metrics to Pharma sponsors
All with the goal of
Improving Patient Outcomes at the Point of Care
. We want you to join us in doing just that.
Who You Are
A lover of patient interaction and skilled at providing patient care
A team player with a bias for action and an attitude that takes personal responsibility
Skilled in all aspects required for conducting an IRB approved clinical trial protocol: identification, screening, randomization, and enrollment of patients, conducting clinic visits, etc.
Skilled at performing and assisting with direct patient care activities: consenting patients, physical assessments, blood draws, medication administration, ECG, etc.
Possess an acute attention to detail for clean data entry, regulatory compliance, productive site visits, efficient study set-up and maintenance, and strict protocol adherence
An expert communicator with the goal of fostering relationships between the research team, PIs, Sponsors, Monitors, and others
A strong advocate for Company values, mission, and initiatives
Not easily distracted: You have the ability to stay focused while running different protocols, resolving and submitting IRB responses and audit findings, tracking AE and SAE events, and maintaining eSource material for assigned studies
Energized by the idea of playing a role in the future of new therapy development in the areas of Gastroenterology, Urology, Dermatology, and/or Oncology
What Success Looks Like for This Role
Taking ownership of assigned studies and patients
Communicating promptly and effectively with leadership and coworkers when you have a question or see something that needs correction
Showing up on time, every time
Ensuring strict compliance to the laws, regulations, and requirements of all applicable governing bodies
Learning and using the technologies we provide to increase efficiency in your day-to-day activities
Embodying our core values of Compassion, Integrity, Collaboration, Innovation, Velocity, and Dedication
What We Offer
Competitive compensation, 401(k) with Company match, a clear career pathway for advancement within the Company, Short- and Long-Term Disability, Health Savings and Flexible Spending Accounts, Health, Dental and Vision insurance Plans, Generous PTO, Adoption Assistance, Paid Holidays, and a wide selection of other voluntary benefits.
Requirements
This job requires legal authorization to work in the US. We are not currently accepting work visas. ObjectiveHealth is an EEO Employer and an E-Verify participant.
$41k-61k yearly est. 60d+ ago
Clinical Research Coordinator
Iterative Scopes Inc.
Clinical research coordinator job in New Albany, IN
Iterative Health is a healthcare technology and services company powering the acceleration of clinicalresearch to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinicalresearch sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise inclinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
Reports To: Manager, ClinicalResearch
Job Summary: The ClinicalResearchCoordinator is responsible to coordinate and administer research study associated activities and ensures that regulatory requirements are followed including adherence to the principles of good clinical practices (GCPs) and adequate human subject protection (HSP). Conduct clinical drug trials in a manner which ensures compliance with regulatory standards, sponsor requirements, patient safety and confidentiality and high professional standards.
FLSA: Non-Exempt
Supervisory Responsibility: This position has no supervisory responsibilities
Key Responsibilities
* Administratively and clinically manage industry sponsored clinical trials.
* Adhere to Research SOP's, Good Clinical Practices, and the study protocols.
* Assist in patient recruitment by performing detailed chart reviews and patient interviews.
* Discuss study protocols with patients and verify the informed consent documentation.
* Review medical history of patient against inclusion/exclusion criteria of studies.
* Perform blood draws, process and ship blood/urine specimens per study protocol and IATA regulations.
* Schedule all patient research visits and procedures consistent with protocol requirements.
* Dispense study medication, collect vital signs, and perform ECGs.
* Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol.
* Complete and maintain case report forms per FDA guidelines and review them against the patient's medical record for completeness and accuracy.
* Function in a clinical role by conducting clinicalresearch studies.
* Monitor patients and providing information to the medical staff and other staff members to assure optimal outcomes.
* Develop written concise research study information and/or tools to be used for the education of staff and the recruitment of patients.
* Maintain compliance of protocols and regulatory guidelines for studies performed in the research area.
* Act as a resource for other staff members regarding investigational issues or guidelines.
* Coordinate the availability and distribution of medications for patients in a timely manner.
* Perform phlebotomy for lab work as required and completes all necessary forms.
* Responsible for the education of patients in all aspects of the disease process and/or clinical study in which the patient may be involved.
* Plan and coordinate the initiation of research study protocols, and the establishment of operating policies and procedures.
* Assist the principal investigator and research director with various administrative tasks associated with the day-to-day operations of research studies and projects.
* Plan and coordinate with the research director the staffing of research studies, to include the recruitment and administration of research support staff, as appropriate to the activity.
* Plan, implement, and maintain data collection and analysis systems in support of the research protocol.
* Monitor the progress of research activities; develop and maintain records of research activities, and prepare periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies.
* Facilitate assigned clinical trial from start to finish.
* Screen participants for all studies independently.
* Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinicalresearch.
* Triage phone calls from subjects, be able to answer clinical care questions within the scope of practice; determine when escalation is required.
* Adhere to infection control/safety guidelines and confidentiality policies.
Core Competencies
* Flexible, Detail oriented, Customer focus, Team working, Initiative, Problem solving, Organized, Self-motivated
General
* Adopt the One GI culture of respect, integrity and accountability that contribute to an internal environment of teamwork and promote a positive brand image to our external customers.
* Incorporate a leadership mindset to your role.
* Comply with One GI procedures, policies, and regulations relevant to your role.
* Successfully completes all One GI training requirements (i.e. OSHA, HIPAA, HealthStream, compliance, etc.)
* Responsible for compliance with all regulatory requirements and/or guidelines. These requirements/guidelines include, but are not limited to: OSHA, HIPAA, Federal Fraud and Abuse laws.
* Computer skills - good working knowledge of MS office.
* Ability to communicate effectively with others, both verbally and in writing.
* Proven ability to manage time, meet deadlines and prioritize.
* Able to maintain standards and professionalism during periods of fluctuating workloads.
* Provide professional service to direct customers of One GI in all interactions.
* Build effective working relationships with other team members.
* Manage daily tasks to ensure business needs are consistently met.
Education and Qualifications
* High School Diploma or equivalent required.
* Associates degree in a clinical or scientific related discipline required.
* Bachelor's degree preferred.
* One (1) year previous experience as a clinicalresearchcoordinator for pharmaceutical phase II or III trials required.
* Previous GI trials experience preferred.
* Clinical experience in an office or hospital setting.
* Research experience or equivalent.
* Must maintain current licensure and/or certification.
* Basic Life Support certification required.
* Knowledge of medical terminology, anatomy, physiology, and pathophysiology.
* Familiarity with health care systems, regulations, policies, and functions.
* Understanding of clinicalresearch documentation standards.
* Knowledge of equipment, supplies, and materials needed for medical treatment.
* Understanding of basic laboratory procedures including phlebotomy, preparation, and screening
* Working knowledge of industry standards and regulatory requirements relevant to clinical drug trails.
* Registered Nurse with five (5) years experience required.
* BSN preferable.
* Membership in local, state and national societies is encouraged.
* Understanding of Code of Federal Regulations for Human Subjects.
* Certified in GCP's and HSP.
* Periodic local travel to other practice locations on an as-needed basis.
* Phlebotomy experience preferred.
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 requiredto speak and hear. Understand/comprehend English as well as read/follow written English instructions.
This role requires continuous activity levels in areas such as walking, standing, pushing, pulling, lifting, and reaching.
It also requires dexterity in motion/flexibility. Ability to lift, push or pull 35+ or more. Must be able to differentiate colors and successfully pass color blind screening.
Work Environment
This job operates in a clinic and procedure room environment. There is potential to be exposed to blood, tissue, and bodily fluids. Involves exposure to Glutaraldehyde/Rapicide (Refer to SDS manual as needed). Occasional exposure to communicable diseases and biohazards.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at anytime with or without notice.
Accommodations
Reasonable accommodations will be made to enable a qualified individual with a disability to perform the non-essential or essential functions of this job. All accommodations will be investigated on an individual basis with theneeds of the department and current staff resources considered. Accommodations will not be made that compromise the safety and health of any associate.
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
$40k-58k yearly est. Auto-Apply 60d+ ago
Clinical Research Coordinator
Iterative Health
Clinical research coordinator job in New Albany, IN
Iterative Health is a healthcare technology and services company powering the acceleration of clinicalresearch to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinicalresearch sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise inclinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
Job Title: ClinicalResearchCoordinator
Location: GHP New Albany/Louisville
Reports To: Manager, ClinicalResearch
Job Summary:
The ClinicalResearchCoordinator is responsible to coordinate and administer research study associated activities and ensures that regulatory requirements are followed including adherence to the principles of good clinical practices (GCPs) and adequate human subject protection (HSP). Conduct clinical drug trials in a manner which ensures compliance with regulatory standards, sponsor requirements, patient safety and confidentiality and high professional standards.
FLSA: Non-Exempt
Supervisory Responsibility: This position has no supervisory responsibilities
Key Responsibilities
Administratively and clinically manage industry sponsored clinical trials.
Adhere to Research SOP's, Good Clinical Practices, and the study protocols.
Assist in patient recruitment by performing detailed chart reviews and patient interviews.
Discuss study protocols with patients and verify the informed consent documentation.
Review medical history of patients against inclusion/exclusion criteria of studies.
Perform blood draws, process and ship blood/urine specimens per study protocol and IATA regulations.
Schedule all patient research visits and procedures consistent with protocol requirements.
Dispense study medication, collect vital signs, and perform ECGs.
Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol.
Complete and maintain case report forms per FDA guidelines and review them against the patient's medical record for completeness and accuracy.
Function in a clinical role by conducting clinicalresearch studies.
Monitor patients and provide information to the medical staff and other staff members to assure optimal outcomes.
Develop written concise research study information and/or tools to be used for the education of staff and the recruitment of patients.
Maintain compliance of protocols and regulatory guidelines for studies performed in the research area.
Act as a resource for other staff members regarding investigational issues or guidelines.
Coordinate the availability and distribution of medications for patients in a timely manner.
Perform phlebotomy for lab work as required and complete all necessary forms.
Responsible for the education of patients in all aspects of the disease process and/or clinical study in which the patient may be involved.
Plan and coordinate the initiation of research study protocols, and the establishment of operating policies and procedures.
Assist the principal investigator and research manager with various administrative tasks associated with the day-to-day operations of research studies and projects.
Plan and coordinate with the research manager the staffing of research studies, to include the recruitment and administration of research support staff, as appropriate to the activity.
Plan, implement, and maintain data collection and analysis systems in support of the research protocol.
Monitor the progress of research activities; develop and maintain records of research activities, and prepare periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies.
Facilitate assigned clinical trials from start to finish.
Screen participants for all studies independently.
Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinicalresearch.
Triage phone calls from subjects, be able to answer clinical care questions within the scope of practice; determine when escalation is required.
Adhere to infection control/safety guidelines and confidentiality policies.
Core Competencies
Flexible, Detail oriented, Customer focus, Team working, Initiative, Problem solving, Organized.
General
Adopt the Impact Research culture of respect, integrity and accountability that contribute to an internal environment of teamwork and promote a positive brand image to our external customers.
Incorporate a leadership mindset to your role.
Comply with Impact Research procedures, policies, and regulations relevant to your role.
Successfully completes all Impact Research training requirements (i.e. OSHA, HIPAA, HealthStream, compliance, etc.)
Responsible for compliance with all regulatory requirements and/or guidelines. These requirements/guidelines include, but are not limited to: OSHA, HIPAA, Federal Fraud and Abuse laws.
Computer skills - good working knowledge of MS office.
Ability to communicate effectively with others, both verbally and in writing.
Proven ability to manage time, meet deadlines and prioritize.
Able to maintain standards and professionalism during periods of fluctuating workloads.
Provide professional service to direct customers of Impact Researchin all interactions.
Build effective working relationships with other team members.
Manage daily tasks to ensure business needs are consistently met.
Provide professional service to direct customers of One GI in all interactions.
Build effective working relationships with other team members.
Manage daily tasks to ensure business needs are consistently met.
Education and Qualifications
High School Diploma or equivalent required.
Associate or Bachelor's degree preferred.
One (1) year previous experience inclinicalresearch for pharmaceutical phase II or III trials required.
Previous GI trials experience preferred.
Clinical experience in an office or hospital setting.
Must maintain current licensure and/or certification.
Basic Life Support certification required.
Knowledge of medical terminology, anatomy, physiology, and pathophysiology.
Familiarity with health care systems, regulations, policies, and functions.
Understanding of clinicalresearch documentation standards.
Knowledge of equipment, supplies, and materials needed for medical treatment.
Understanding of basic laboratory procedures including phlebotomy, preparation, and screening.
Working knowledge of industry standards and regulatory requirements relevant to clinical drug trials.
Nurse Coordinator Requirements
Active Registered Nurse license required
Ability to be licensed in multiple states required
Experience with intravenous infusions preferred
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
$40k-58k yearly est. Auto-Apply 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
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