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Clinical research coordinator Jobs in Indianapolis, IN

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Clinical research coordinator • indianapolis in

Last updated: 22 hours ago
  • Promoted
Clinical Research Scientist- Olomorasib

Clinical Research Scientist- Olomorasib

Eli Lilly and CompanyIndianapolis, Indiana, United States
Full-time
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...Show moreLast updated: 15 days ago
Clinical Coordinator

Clinical Coordinator

Recovery Centers of AmericaIndianapolis, IN
Full-time
The Clinical Coordinator provides support and supervision of the quality of patient care as a member of a multi-disciplinary team. He / She also is responsible for the safe and effective operation of ...Show moreLast updated: 30+ days ago
Clinical Coordinator (QMA)

Clinical Coordinator (QMA)

Capital Senior LivingIndianapolis, IN , US
Full-time
Find your joy here, at The Harrison, a Sonida Senior Living community!.We offer a comprehensive benefit package to include competitive wage / salary, health and dental insurance, k with company match...Show moreLast updated: 30+ days ago
Research Regulatory Coordinator

Research Regulatory Coordinator

Community Health NetworkIndianapolis, IN
Full-time
Hours : Mon-Fri 8 : 00 am to 5 : 00 pm.Community Health Network has an excellent opportunity available within our Clinical Research Department as a Research Regulatory Coordinator.If you are looking for...Show moreLast updated: 30+ days ago
Clinical Research Physician – Incretins

Clinical Research Physician – Incretins

LillyIndianapolis, Indiana, United States of America
Full-time
We’re looking for people who are determined to make life better for people around the world.Job Description Executive Director Global Medical Affairs. Through the application of scientific and medic...Show moreLast updated: 30+ days ago
Clinical Research Monitor, Midwest

Clinical Research Monitor, Midwest

Edwards LifesciencesUSA, Indiana, Remote
Remote
Full-time
Imagine how your ideas and expertise can change a patient’s life.We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transfor...Show moreLast updated: 30+ days ago
  • Promoted
Clinical Research Coordinator

Clinical Research Coordinator

Indiana UniversityIndianapolis, IN, US
Full-time
Indiana University (IU) School of Medicine is a national leader in medical research and education.With more than 60 academic departments and specialty divisions across 9 campuses statewide and stro...Show moreLast updated: 22 days ago
  • Promoted
Clinical Research Laboratory Assistant

Clinical Research Laboratory Assistant

ActalentIndianapolis, IN, US
Full-time
Clinical Research Laboratory Assistant.Join our dynamic team as a Clinical Research Laboratory Assistant, where you will work in a laboratory setting to process blood samples according to research ...Show moreLast updated: 3 days ago
Research Coordinator Registered Nurse RN

Research Coordinator Registered Nurse RN

CuberfeedIndianapolis
Full-time
Research Coordinator Registered Nurse RN Indianapolis IN.Cuberfeed is searching for an ideal candidate to fill the position of. Research Coordinator Registered Nurse RN in Indianapolis IN.Ascension ...Show moreLast updated: 22 days ago
Research Coordinator

Research Coordinator

LHHIndianapolis, Indiana
Permanent
Indianapolis, IN (86th & Naab).LHH Recruitment Solutions has partnered with a healthcare organization seeking a Research Coordinator. This position is based in Indianapolis, IN and requires 100% on-...Show moreLast updated: 30+ days ago
Field Clinical Research Specialist.

Field Clinical Research Specialist.

MedtronicIndianapolis, Indiana, US
Temporary
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident —we work hard to cultivate a workforc...Show moreLast updated: 30+ days ago
CLINICAL COORDINATOR

CLINICAL COORDINATOR

HEALTH AND HOSPITAL CORPORATIONIndianapolis
Full-time
The Indianapolis Healthy Start (IHS) Clinical Coordinator position.IHS to expand its capacity to provide direct access to well woman care and maternity care services to reduce barriers and help add...Show moreLast updated: 30+ days ago
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Vice President, Clinical Research Endocrinology

Vice President, Clinical Research Endocrinology

ConfidentialIndianapolis, IN, United States
Full-time
Vice President, Clinical Research Endocrinology.Fast-growing biopharmaceutical company.The Company is in search of a Vice President for Clinical Research in Endocrinology.The successful candidate w...Show moreLast updated: 22 hours ago
Clinical Research Coordinator

Clinical Research Coordinator

Franciscan HealthIndianapolis, Indiana
Full-time
Franciscan Health Indianapolis Campus.S Emerson Ave Indianapolis, Indiana 46237.With 12 ministries and access points across Indiana and Illinois, Franciscan Health is one of the largest Catholic he...Show moreLast updated: 30+ days ago
Clinical Research Coordinator

Clinical Research Coordinator

Indiana University BloomingtonIndianapolis, Indiana
Full-time
Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies.Recognizes situations requiring prompt escalation and demonstrates actions to mi...Show moreLast updated: 28 days ago
  • Promoted
Clinical Research Coordinator, VA Licensed

Clinical Research Coordinator, VA Licensed

VirtualVocationsIndianapolis, Indiana, United States
Full-time
A company is looking for a Clinical Research Coordinator to support clinical research studies in the Department of Pediatrics. Key Responsibilities : Assist in subject recruitment, eligibility dete...Show moreLast updated: 1 day ago
People also ask
Clinical Research Scientist- Olomorasib

Clinical Research Scientist- Olomorasib

Eli Lilly and CompanyIndianapolis, Indiana, United States
15 days ago
Job type
  • Full-time
Job description

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.

Job Summary

Through the application of scientific training and clinical training and expertise, the Development  clinical research scientist participates in : the development, conduct and reporting of corporate / global clinical trials in support of registration and commercialization  of the product; the implementation of global clinical trials; the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions  and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the external clinical customer community,  including thought leaders; the development  and implementation of the business unit and global strategy for the product; and various medical activities in support of demand realization.

The clinical research scientist serves as a scientific resource for study teams, departments, and others as needed. The Clinical Research Scientist must be aware of and ensure that all their activities are in compliance with current local and international regulations, laws, guidance's (for example, FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the medical vision.

Responsibilities : Clinical Planning

  • Contribute to business unit and global alignment of clinical strategy and clinical plans.
  • Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.

Clinical Research / Trial / Execution and Support

  • Participate in medical review of clinical trial data to ensure comprehensiveness, accuracy and validity of the information in advance of database locks and subsequent analyses.
  • Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (e.g., annual reports) according to the agreed upon project timeline.
  • Provide protocol oversight and input into informed consent documents.
  • Supports the monitoring of patient safety during study and participates in the global product safety reviews including the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.
  • Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions).
  • Review and collaborates with CRP on the approval of risk profiles to ensure to ensure appropriate communication of risk to study subjects.
  • Participate in investigator identification and selection, in conjunction with clinical teams.
  • Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval / notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
  • Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
  • Serve as resource to clinical operations / CTMs / clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
  • Understand and actively address the scientific information needs of all investigators and personnel.
  • Review lIT proposals and publications, as requested by CRP or Director-Medical.
  • Scientific Data Dissemination / Exchange

  • Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals.
  • Understand and address the unsolicited scientific information needs of external health care professionals according to guidelines above.
  • Participate in reporting of clinical trial data in Clinical Trial Registry activities.
  • Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
  • Prepare or review scientific information in response to customer questions or media requests
  • Provide telephone follow-up or specific written information requested by health care professionals as per global SOPs.
  • Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a local, national, regional and possibly international basis.
  • Support the design of customer research as medical expert
  • Support medical information associates in preparation and review of medical letters and other medical information materials.
  • Support data analysis and the development of slide sets (through reviewing and / or approving) and publications (abstracts, posters, manuscripts).
  • Develop and maintain appropriate collaborations and relationships with relevant professional societies.
  • Support training of medical personnel, including geographic / affiliate medical personnel as assigned, medical and outcome liaisons and global patient outcomes personnel.
  • Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events)
  • Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.
  • Regulatory Support Activities

  • Participate in development and review of label changes and labeling modifications in collaboration with affiliates, brand teams, regulatory, and legal.
  • Provide medical expertise to regulatory scientists.
  • Support / assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective.
  • Participate in advisory committees.
  • Participate in risk management planning along with affiliates and Global Patient Safety (GPS).
  • Business / customer support (ore and post launch support)

  • Contribute to the development of medical strategies to support brand commercialization activities by working closely with business unit, brand team, clinical plans manager / project management associates and other cross-functional management during the development of the local business plan.
  • Understand and anticipate the scientific information needs of all Development customers (payers, patients, health care providers).
  • Actively address Development customer (payer, patient, and health care providers) questions in a timely fashion by leading data analyses and new clinical or global patient outcomes research efforts.
  • Establish effective collaborations with marketing personnel in the various geographic regions to further corporate demand realization.
  • Establish and maintain contact with external experts and opinion leaders; maintain a credible scientific expertise to facilitate these contacts.
  • Contribute as a scientific and medical expert to activities and deliverables of the PRA organization, in particular giving clinical input and insight to develop payer partnership programs and defend the product value.
  • Support business-to-business and business-to-government activities as medical expert.
  • Contribute actively on an ongoing basis to the strategic planning for the brand.
  • By offering scientific and creative input, contribute to the development, review, and approval of promotional materials and tactics as needed.
  • Become familiar with market archetypes and potential influence on the medical interventions for the product.
  • Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his / her medical knowledge. Become a patient advocate, as well as a medical expert.
  • Participate in PhRMA or other local or national trade associations as appropriate.
  • Scientific I Technical Expertise and continued development

  • Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product
  • Responsible for the scientific training of the clinical study team.
  • Acts as scientific consultant and protocol expert for clinical study team members and others in medical.
  • Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near term (1-2 years) and longer term (3-5 years).
  • Explore and take advantage of opportunities for extramural scientific experiences
  • Attend, contribute and participate in scientific symposia, as well as administrative / business workshops and training.
  • General Responsibilities

  • Actively set and meet individual professional development goals and contribute to the development of others.
  • Support the management team, including the Sr. Director-Medical, in preparation and administration of the business unit development budget.
  • Actively participate in recruitment, diversity and retention efforts.
  • Collaborate proactively and productively with all alliance, business and vendor partners.
  • Participate in active coaching by providing timely and constructive feedback to co-workers, others on the medical team, in the spirit of development, increased team effectiveness and cohesiveness.
  • Participate in committees, Six Sigma initiatives and task forces as requested by local / corporate management
  • Ensures that at all times is adequately qualified and trained in the tasks required to perform. Includes accountability and compliance for maintaining a current curriculum training map for self.
  • Model the leadership behaviors
  • Be an ambassador of both patients and the Lilly Brand
  • Qualifications :

    Applicants should have one of the two below 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) and one of following : 3-5 years of clinical experience or 3-5 years of pharmaceutical experience (2 of which is in clinical development) OR
  • Have a BS or Masters degree in health / medical / scientific or related field and 7-10 years experience that is directly related to either clinical trial or Drug / clinical development (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs)
  • Other qualifications :

  • Pharmaceutical industry experience, preferred
  • Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills
  • Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills
  • Demonstrated 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
  • 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 ( https : / / careers.lilly.com / us / en / workplace-accommodation ) 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), enAble (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

    142,500 - $228,800

    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.

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