Clinical Research Associate 1
Clinical research associate job in Indiana
Responsible for providing Clinical Research 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 clinical research 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 clinical research 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
Clinical Research Scientist - Breast Cancer Franchise
Clinical research associate 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 Clinical Research 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 comply 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 in clinical 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.
Supervise and participate 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.
Participate 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 strategic planning 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 or equivalent experience in Health-related field with 10+ years' industry experience
3+ years of clinical research scientist experience/clinical trial experience
Direct Line Leadership experience
Additional Information/Preferences:
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.
Proven 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
Auto-ApplyClinical Research Associate
Clinical research associate job in Lexington, KY
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
We are currently seeking a Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
What you will be doing
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
Collaborating with investigators and site staff to facilitate smooth study conduct.
Performing data review and resolution of queries to maintain high-quality clinical data.
Contributing to the preparation and review of study documentation, including protocols and clinical study reports
Your profile
Bachelor's degree in a scientific or healthcare-related field.
Minimum of 2 years of experience as a Clinical Research Associate.
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
Strong organizational and communication skills, with attention to detail.
Ability to work independently and collaboratively in a fast-paced environment.
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
Auto-ApplyClinical Research Coordinator II
Clinical research associate job in Indianapolis, IN
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into 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 clinical research 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 Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research 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 Clinical Research Coordinator experience required
* Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator
* 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, IN clinic.
* 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
* 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: ********************************
Clinical Research Coordinator II
Clinical research associate job in South Bend, IN
Our clinical research company is looking to hire a qualified candidate for the full-time position of Clinical Research Coordinator II. The ideal candidate will possess 3+ years of clinical research coordination experience, and have a strong desire to work directly with patients.
Who We Are
ObjectiveHealth is a clinical research 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 clinical research 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.
Clinical Research Coordinator
Clinical research associate 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 Clinical Research Coordinator, you will be responsible for executing research projects under the direction of the primary investigator and for performing in accordance to study regulatory processes, standard operating procedures, and study protocols.
The Opportunity
Participate in the planning and execution of research projects under the direction of the Medical Director and the primary investigator.
Function as an integral part of the research and comprehensive care teams, working with colleagues to meet deadlines and maintain a flexible schedule based on the needs of patients, the department, and IHI.
Create a study budget in InfoED in collaboration with the finance department. Work with the finance department to assist with billing, invoicing, tracking status on payments due or past due, documenting patient stipend requests, and charting completed study visits.
Assess patients for inclusion and exclusion criteria to determine study eligibility, and work cooperatively with the comprehensive team to coordinate study-related patient care. Explain informed consent for each study participant; document refusals according to protocol.
Ensure accurate and prompt communication with patients, the primary investigator, research manager, external contacts, study sponsors, and monitors.
Prepare study-related documentation such as protocol worksheets, procedural manuals, drug dispensation records, regulatory forms, adverse event reports; submit all relevant study documents to the institutional review board.
Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices. Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
Participate in internal quality assurance; review monitor reports for trends across studies.
Requirements
Minimum Associate's degree in 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 in Indiana and serves the entire state through services available in Indianapolis and at outreach clinics.
IHI is a leader in hemophilia care, education and clinical research and has a dedicated on-site multidisciplinary staff to ensure availability of a wide range of required services.
IHI participates in national and international clinical research, 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 clinical research projects involving bleeding disorders, sickle cell disease, thrombosis and more.
Innovative Hematology, Inc. is an Equal Opportunity Employer.
Clinical Research Coordinator II
Clinical research associate job in Indianapolis, IN
Job Details Indianapolis - Indianapolis, INClinical Research Coordinator II
The Clinical Research Coordinator II will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC II will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis.
DUTIES & RESPONSIBILITIES
Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis.
Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to:
a. Sponsor-provided and IRB-approved Protocol Training
b. All relevant Protocol Amendments Training
c. Any study-specific Manuals Training, as applicable
d. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner.
Adherence to ALCOA-C Standards with all the relevant clinical trial documentation.
Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.
Demonstration of appropriate and timely follow-up on the action items, at their respective sites.
Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols.
Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols.
Demonstrating adherence and compliance to the assigned protocols at their respective site(s).
Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s)
Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s).
Demonstrating visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s)
Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s).
Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines.
Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.
Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).
Being prepared for and available at all required company meetings.
Submitting required administrative paperwork per company timelines.
Occasionally attending out-of-town Investigator Meetings
Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives
Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent
Facilitate effective communication between patients, healthcare providers, and research staff
2Any other matters as assigned by management.
KNOWLEDGE & EXPERIENCE
Education:
High School Diploma or equivalent required; Bachelor's degree preferred
Foreign Medical Graduates preferred
Experience:
At least 2 years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting.
Credentials:
ACRP or equivalent certification is preferred
Knowledge and Skills:
Be an energetic, go-getter who is detail-oriented and can multi-task.
Be goals-driven while continuously maintaining quality.
Proficient communication and comprehension skills both verbal and written in the English language are required.
Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.
Clinical Scheduler, Dr. Anne Rossell, OB, Downtown Nashville
Clinical research associate job in Nashville, TN
Job Details 222 22ND AVE NORTH - NASHVILLE, TN Full Time (32-40 Weekly Hours) Not Specified None Day Health CareDescription
SUMMARY: The Clinical Scheduler is responsible for effectively and professionally managing patient flow from arrival to departure; performing various clerical duties; deals with other clinic personnel, patients and visitors, and fellow employees to ensure good internal and public relations. Handles incoming calls, schedules appointments, returns calls from patients, calls in prescriptions/changes as well as other phone responsibilities. Other duties may be assigned.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Answer incoming telephone calls; handle patient concerns as appropriate or route to appropriate personnel.
Schedule appointments according to doctor's instructions and/or template in the Patient/Practice Management (Scheduling) system.
Review and scan all lab results, correspondence and necessary documents in the patient record.
Handle incoming calls-take complete and accurate phone messages including caller's name, telephone number. For sick calls include signs and symptoms, drug allergies, present medications, and pharmacy phone number. Prescription refills need to include the name of drug, dosage, frequency, and pharmacy phone number. Document appropriately in the EMR system.
Return patient calls in a timely manner
Call in prescriptions/changes according to the doctor's instruction (doctor's order). Document appropriately in the EMR system.
Check for accuracy of insurance status, eligibility, account information, and all vital statistics.
Complete referrals and pre-certifications in a timely manner-should have a good understanding of all insurance companies and referral/ pre-certifications requirements.
Must have predictable and consistent attendance
SECONDARY DUTIES
Open mail daily.
Maintain a clean and orderly work area.
Check for accuracy of insurance status, eligibility, account information, and all vital statistics.
SUPERVISORY RESPONSIBILITIES
This job has no supervisory responsibilities.
Qualifications
Ability to cope with busy, challenging office environment.
Strong phone skills
Pleasant, courteous personality
Basic typing and computer skills, (Patient/Practice Management (Scheduling) & Electronic Med. Records experience helpful) minimum 25 wpm typing
Ability to communicate effectively both written and verbally.
Minimum of two years' experience in a physician's office.
EDUCATION and/or EXPERIENCE
High school education or equivalent.
3-5 years' experience office environment in the medical field.
KNOWLEDGE, SKILLS AND ABILITIES
Skill in establishing and maintaining effective working relationships with patients, medical staff, and the public. Ability to maintain quality control standards. Ability to recognize problems and recommend solutions. Ability to interpret, adapt and apply guidelines and procedures. Finally, articulate speech and pleasant, professional manner are necessary.
CERTIFICATES, LICENSES, REGISTRATIONS
Healthcare Provider BLS Certification
PHYSICAL DEMANDS AND WORK ENVIRONMENT
Must be able to stand/sit for 8 to 10 hours a day
Requires regular walking, bending, pushing, pulling and lifting
Must be able to lift at least 10-15lbs
Must be able to assist patients with transfers from chair to wheelchair, to exam tables, and back to wheelchair/chair
Must be able to assist patient with turning/positioning on exam table
Must be able to push patient in wheelchair
Must be able to manipulate objects-reaching, grasping, handling
Must exhibit good communication skills-understand, respond and translate into action
Clinical setting; exposure to communicable diseases, medical preparations and other conditions common to a clinical environment.
Dr. Baessler's Clinic Roomer (Certified Medical Assistant)
Clinical research associate job in Fishers, IN
Job Description
The Float/Roomer is responsible for making patients feel comfortable during the visit, directing patients while in the clinic, and performing initial assessment and intake of information including, but not limited to, past surgical, medical, family and social history, taking and recording patient vital signs, and interviewing patient to fully understand the reason for the visit. Individuals in this role will provide care for clinic patients following established standards and practices. This individual is responsible for delivering patient care and assisting in procedures as directed by physicians. This position is responsible for maintaining and updating patients records with a high degree of accuracy in a timely and efficient manner.
Type: Full Time
Location: Fishers, IN office
Travel Required: 1 day a week to Zionsville, IN and Fishers, IN
Prepares patients for examination and treatment by observing, recording, and assessing patient's condition, noting reactions to drugs and treatments, obtaining vital signs, and taking patient's past surgical, medical, social, and family history and accurately entering information into the electronic health record.
Updates and maintains patient files, records, posts tests and examination results, formulates and updates patient care plans, and other information with a high degree of accuracy and efficiency to provide a smooth and timely flow of patients through the clinic.
Performs selected nursing duties, including assisting physicians in preparing for minor surgeries, procedures and physicals; assisting physician during treatment as needed; obtain specimens and administer injections or tests as ordered by physician, arranging for additional testing as needed, and apply or remove casts, splints, and dressings as necessary.
Explain and demonstrate home physical therapy exercises or rehabilitation techniques to patients.
Prepares exam and treatment rooms with necessary instruments based on physician and patient needs.
Maintains and prepares supplies and equipment for treatments, including sterilization and ensuring clinic area is stocked with proper equipment at all times and ordering as necessary.
Places a high priority on and maintains strict confidentiality in all situations.
Participates in professional development activities and maintains applicable professional affiliations and certifications as required.
Attends and participates in required organizational meetings and committees as requested.
Perform additional related duties as assigned.
Education, Experience, and Certification/License Requirements:
Completion of an accredited program medical assisting (Associate's degree). One to two years' professional experience in a clinical setting preferred. Must possess and maintain in good standing certification from the American Association of Medical Assistants (CMA or CCMA). Must maintain current BLS certification.
Working Conditions/Physical Requirements:
Working environment is in a clinical environment. Exposure to communicable diseases, toxic substances, ionizing radiation, medicinal preparations and other conditions common to a clinic environment. Work requires standing for long periods of time and excessive walking. Position requires full range of body motion including handling and lifting/assisting patients, manual and finger dexterity and eye-hand coordination. Occasionally lifts and carries items weighing up to 100 pounds. Requires normal visual acuity and hearing must be in normal range for telephone contacts and to interact directly with patients. Regularly interacts with staff, physicians, and the public, which may involve dealing with angry or upset people. Work may be stressful at times.
Clinical Research Assistant
Clinical research associate job in Valparaiso, IN
Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.
As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.
Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.
Summary:
The Clinical Research Assistant assists the Clinical Operations Team in a multi-functional capacity to carry out all assigned tasks associated with the collection, documentation, and maintenance of clinical data including phlebotomy/laboratory, data entry and administrative responsibilities.
Responsibilities
Duties/Responsibilities:
Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Velocity's SOPs
Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations
With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc) within scope of the protocol, local law and regulations
Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable
Track, order and maintain inventory of all laboratory and study related supplies throughout course of the clinical trial
Enter source data into the sponsor's and/or vendor's data portal and resolve basic queries in a timely manner under the direction of the Clinical Research Coordinator
Communicate with coworkers, leadership, study subjects, sponsors, CROs, and vendors under the direction of the Clinical Research Team
Understand good documentation practices when collecting, transferring data to sponsor/CRO data capture systems and resolving queries under the direction of the Clinical Research Coordinator
Understand the informed consent process with emphasis on ensuring initial and ongoing consent of study subjects
Understand basic elements of regulatory documentation required to initiate, maintain and close a clinical research trial
Understand and participate in patient recruiting tasks including but not limited to prescreening potential subjects for clinical research trials either via phone or in person
Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information
Ability to escalate potential patient safety issues such as adverse events, serious adverse events, and adverse events of special interest to the Clinical Research Team
Cleaning, organizing, and disinfecting the patient care, lab and lab equipment areas as needed
Prepare source document charts, copy and/or file medical records and study related documents as required.
Perform front office duties as needed including but not limited to answering phones, scheduling subjects, making reminder calls and updating patient tracking systems.
Other duties as assigned
Qualifications
Education/Experience:
High School Graduate and/or technical degree with minimum of 1 year of relevant experience in life sciences industry
Required Licenses/Certifications:
Phlebotomy if applicable and required by state law
Intramuscular dose administration and preparation if applicable and required by state law
Required Skills:
Demonstrated knowledge of medical terminology
Demonstrated ability to use the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.
Understanding of verbal, written, and organizational skills
Demonstrated ability to work as a team player
Demonstrated ability to read, write, and speak English
Demonstrated ability to multi-task
Demonstrated ability to follow written guidelines
Demonstrated ability to be flexible/adapt as daily schedule may change rapidly
Required Physical Abilities:
Sit or stand for long periods of time
Communicate in person and by a telephone
Limited walking required
Limited to lifting up to 30 pounds
NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
Auto-ApplyClinical Research Assistant
Clinical research associate job in New Albany, IN
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research 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 in clinical 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: Clinical Research Assistant
Location: GHP New Albany/Louisville
Reports To: Manager, Clinical Research
Job Summary:
The Clinical Research Assistant, under the guidance and supervision of the Clinical Research Manager and Principal Investigator (PI), ensures the integrity and quality of clinical trials are maintained and conducted in accordance w/ federal, state, and local regulations, Institutional Review Board (IRB) approvals, and Impact Research policies, and procedures. This position is primarily responsible for the accurate completion of visit procedures and collection of information for study patients according to protocols, and for protecting the health, safety, and welfare of research participants.
FLSA: Non-Exempt
Supervisory Responsibility: This position has no supervisory responsibilities
Key Responsibilities
Assist in the implementation of clinical research studies.
Recruit, screen, and enroll study participants.
Coordinate and schedule study visits and follow-ups.
Collect, process, and manage biological samples.
Maintain accurate and detailed records of research activities.
Communicate with research participants and address their concerns.
Ensure compliance with regulatory and ethical standards.
Assist in the preparation of study-related documents and reports.
Monitor study progress and report any adverse events or protocol deviations.
Coordinate with clinical research coordinators, other departments and staff involved in the study.
Other duties as assigned
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 Research 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.
Previous experience in clinical research or healthcare setting preferred
Associate's or Bachelor's degree in a relevant field preferred
Basic understanding of clinical research principles and methodologies.
Strong organizational and time management skills.
Must be proficient in Microsoft Office Word and Excel, electronic health systems and databases used in research environment, or willingness to learn and demonstrate proficiency within three months of hire
Ability to work independently and as part of a team.
Ability to follow protocols and guidelines closely.
Basic knowledge of medical terminology.
Ability to handle sensitive and confidential information.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to 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 is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stoop as necessary. This position requires the ability to occasionally lift office products and supplies up to 20 pounds. This job operates in a professional office environment. This role routinely uses standard office equipment.
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 any time 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 the needs 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.
Auto-ApplyClinical Research Assistant- Medical Assistant - Urology of Indiana
Clinical research associate job in Carmel, IN
The Clinical Research Coordinator (CRC) is responsible for conducting and documenting clinical research and trials for the Research Division while adhering to Good Clinical Practice/ICH Guidelines and the Code of Federal Regulations.
What You'll Be Doing
Administratively and clinically coordinates a team to effectively conduct a minimum of six clinical trials (level 1-3 clinical research protocol) and evaluates/analyzes clinical data and trial results. Schedule, plan, and participate in study monitoring visits and address any potential queries or deviations in accordance with the study contract. Acts as a liaison between the sponsor and the research department.
In collaboration with the Clinical Manager advises treating physicians on clinical protocol opportunities and procedures. Recruitment of study subjects, including use of professional experience, discretion, and judgment to include or exclude potential subjects based on trial criteria.
Acts as a study resource for patients and families. Discusses study protocols with patients and verifies the informed consent process and documentation. Addresses any questions or concerns the research patient may have regarding the study. Provides patient with written communication of their participation.
Ensures subjects understanding and willingness to continue participation as well as conduct study-specific procedures and assessments (within his/her scope of practice) at each visit. This includes providing patients with all treatment option information within their scope of practice such as pamphlets and protocol direction.
Dispenses study medications in accordance with protocol requirements within his/her scope of practice. Performs investigative product accountability for accurate compliance.
Collects, processes, and ships blood/urine specimens at scheduled times.
Supervisors scheduling of research patient visits and procedures consistent with protocol requirements. Performs study-specific procedures, including but not limited to ECGs, vital signs, height, weight, injections, etc. within his/her scope of practice.
Collect, compile, and maintain source documentation. Completes and maintains case report forms per FDA guidelines while ensuring source completeness and accuracy. Prepares and participates in quality assurance audits by study sponsors, federal agencies, or specially designated review groups.
Responsible for the reporting of and follow-up on adverse events and serious adverse events per study protocol.
Screens all laboratory and radiographic results following protocol procedures regarding abnormal results assuring that all results are reviewed by a physician, PI or SI for clinical significance.
Contacts outside health care providers and communicates with subjects to obtain follow-up information.
Ensures scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials.
Ensures filing and maintenance of all regulatory documents.
Attends sponsor meetings for the purpose of education and understanding of protocols or protocol addendums.
Maintains required continuing education hours required for certifications.
Adherence and knowledge of OSHA including the location and use of Material Data Safety Sheets (MSDS).
Maintains a high level of patient confidentiality.
Performs all other duties as assigned.
What We Expect from You
Associate's or Bachelor's Degree from an accredited college or university.
Good Clinical Practice (GCP) Certificate
International Air Transport Association (IATA) Certificate
CCRC certification through an accredited organization (ACRP/SoCRA) is required
2-3 years of related Research Experience Preferred.
Reasoning Ability
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Computer Skills
To perform this job successfully, an individual should have thorough knowledge in computer information systems.
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. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
Work Environment
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.
Other Duties
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 any time with or without notice.
Travel
Travel is primarily local during the business day, although some out-of-the-area and overnight travel may be expected.
Benefits We Offer:
Medical
Dental
Vision
Health Savings Account
Life Insurance
Paid Time Off
401K plus Company Match of up to 4%
Accident and Critical Illness Coverage
Long-Term and Short-Term Disability
Employee Assistance Program
What We are Offer You
At U.S. Urology Partners, we are guided by four core values. Every associate living the core values makes our company an amazing place to work. Here “Every Family Matters”
Compassion
Make Someone's Day
Collaboration
Achieve Possibilities Together
Respect
Treat people with dignity
Accountability
Do the right thing
Beyond competitive compensation, our well-rounded benefits package includes a range of comprehensive medical, dental and vision plans, HSA / FSA, 401(k) matching, an Employee Assistance Program (EAP) and more.
About US Urology Partners
U.S. Urology Partners is one of the nation's largest independent providers of urology and related specialty services, including general urology, surgical procedures, advanced cancer treatment, and other ancillary services. Through Central Ohio Urology Group, Associated Medical Professionals of NY, Urology of Indiana, and Florida Urology Center, the U.S. Urology Partners clinical network now consists of more than 50 offices throughout the East Coast and Midwest, including a state-of-the-art, urology-specific ambulatory surgery center that is one of the first in the country to offer robotic surgery. U.S. Urology Partners was formed to support urology practices through an experienced team of healthcare executives and resources, while serving as a platform upon which NMS Capital is building a leading provider of urological services through an acquisition strategy.
U.S. Urology Partners is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.
Auto-ApplyClinical Research Associate II
Clinical research associate job in Louisville, KY
Responsible for providing Clinical Research 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 clinical research 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 clinical research 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 and 401K
Research Scientist - Clinical
Clinical research associate 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.
Clinical Research Scientist - Medical Affairs Allergy, Immunology BU
Purpose:
The Medical function throughout the Lilly enterprise brings scientific objectivity, clinical expertise and experience in patient care that enhance Lilly's R&D, but Medical Affairs extends those benefits in its interactions with the customer and uses those customer experiences to inform ongoing development and use of Lilly's medications.
Medical Affairs (MA) plays a critical role in anticipating and interpreting the constant and rapid changes happening in the complex world of healthcare. Medical Affairs leads efforts to identify and address Clinical Care Gaps, generate evidence, and share science across communication channels.
The application of scientific and clinical training, and expertise, positions the Medical Affairs Clinical Research Scientist (CRS) an integral member of the medical affairs team.
The Medical Affairs CRS supports the medical strategic planning supporting launch and commercialization of our treatments. Additionally, the MA CRP leads the medical strategy addressing patients' needs and ultimately enhancing the customers' experience in interacting with the company. The definition of "customer" here includes patients, providers (HCPs), and payers.
Specific activities include developing or contributing to the global and/or regional clinical/medical plan in his/her therapeutic area of responsibility, the development, conduct and reporting of local clinical trials; the implementation of global clinical trials conducted in local affiliates/countries; the reporting of adverse events as mandated by corporate patient safety; 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; the outreach medical activities aimed at the external clinical customer community, including thought leaders; and various medical activities in support of demand realization. In addition, with input from the Director-Medical and Business Unit Team Physician/Regional Medical Leader, the CRS is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respective Medical Affairs business unit brand team(s), global Development team, Therapeutic Area Program Phase, Early Phase I Clinical Pharmacology, and Translational Medicine team(s).
The Clinical Research Scientist serves as a scientific resource for study teams, departments, and others as needed. The CRS is aware of and ensures that all activities of the medical team (and direct reports, if applicable) are in compliance with current local and international regulations, laws, guidance (for example, FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, global quality standards, the Principles of Medical Research and activities are aligned with the medical vision.
Primary Responsibilities:
This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
The primary responsibility of the Medical Affairs CRS is to provide expert scientific and clinical support to all aspects of the local and global business, to ultimately enhance the customers' experience and develop medical strategies that improve patient outcomes. This includes informing the identification of Clinical Care Gaps (CCG), Integrated Evidence Generation (IEG) planning, product lifecycle planning, and evidence dissemination plans aligned with medical strategy.
This includes local marketed product support (participate in the development of the "patient journey" and the strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies (medical support for New and Supplemental New Drug Submissions and participating and presenting at meetings with government regulatory agencies), medical support for PRA (providing medical guidance on the PRA plan and interacting with government PRA agencies as needed), and leading in local scientific data dissemination (leading and presenting at conferences, advisory boards, etc., and overseeing the development of the scientific content of educational programs). These responsibilities are generally related to late-phase and marketed compounds but can also include early phase trials (for example, phase I and II trials).
The global team CRS is responsible for collaborating with the global development teams in the planning, startup and conduct of phase 3b/4 studies (and phase I and II studies where applicable), as well as non-clinical trial solutions/activities that are conducted in affiliates/countries as described in the clinical plan. In addition, the CRS, if assigned, is responsible for support of global Development studies conducted in affiliates/countries. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned.
Business/ customer support (pre and post launch support)
Understand and anticipate the scientific information needs of all local/regional customers (payers, patients, health care providers)
Actively address customer (payer, patient and health care providers) questions in a timely fashion by leading data analyses and new clinical or health outcomes research efforts.
Contribute to the development of medical strategies to support brand commercialization activities by working closely with the global Medical Affairs and brand teams, Global Patient Outcomes/Real World Evidence and global PRA, clinical management or personnel and other cross-functional management during the development of the local business plan.
Contribute as a scientific and clinical expert to activities and deliverables of the PRA organization, 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 currently marketed brands.
By offering scientific and creative input, contribute to the development, review, and approval of promotional materials for the brand team.
Support training of sales representatives, and other medical representatives.
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 patient advocate, as well as a medical expert supporting identification of Clinical Care Gaps (CCGs).
Provide medical insight and training to patient support programs (for example, Diabetes Nurse Educators Service).
Understand and apply knowledge of customer insights to all customer-related activities.
Participate in local or national trade associations as appropriate.
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 actively address the unsolicited scientific information needs of external health care professionals according to guidelines above.
Support the planning of symposia, advisory board meetings, and and/or the facilitation of other meetings with health care professionals.
Support medical information associates in preparation and review of medical letters and other medical information materials.
Support training of local medical personnel, including medical and/or outcome liaisons and health outcomes staff.
Prepare or review scientific information in response to customer questions or media requests.
Provide follow-up to information requested by health care professionals as per global SOPs.
Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts).
Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community on a local, national, regional, and possibly international basis.
Develop and maintain appropriate collaborations and relationships with relevant professional societies.
Support the design of customer research as medical expert.
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).
Support efforts in Integrated Evidence Generation (IEG) planning, participate in data analyses, development of scientific data dissemination including personal and non-personal channel strategy, and preparation of final reports and publications.
Participate in reporting of clinical trial data in Clinical Trial Registry activities.
Clinical Planning
Communicate and collaborate with Director-Medical and Business Unit Team Physician/Regional Medical Leader as needed to ensure life cycle plans for drugs in development address customer needs or communicate and collaborate such needs as delegated by Director-Medical and Business Unit Team Physician/Regional Medical Leader, as needed, to global Medical Affairs and Development teams, Global Patient Outcomes/Real World Evidence, PRA, Therapeutic Area Program Phase, and Early Phase /EPM/Translational Medicine teams.
Communicate local/regional research needs and collaborate with other regions and the global Development and Medical Affairs teams, Global Patient Outcomes/Real World Evidence, and PRA teams to ensure Phase 3, 3b, and 4 (and Phase I and II where applicable) clinical programs meet the needs of local/regional customers (for example, through global medical planning processes).
Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
Represent the clinical needs of the country/region to the business unit medical leadership in the development of clinical strategies, development plans and study protocol design.
Clinical Research/Trial Execution and Support
Review and approve local informed consent documents and risk profiles to ensure appropriate communication of risk to study subjects.
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).
Collaborate with clinical research staff, regional clinical operations staff, statisticians, global patient outcomes, research scientists and selected investigators in the development of protocols and data collection requirements.
Participate in investigator identification and selection, in conjunction with clinical teams.
Ensure that the clinical operations team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
Assist in the planning process and participate in study start-up meetings and other activities to provide the appropriate scientific training and information to investigators and site personnel.
Serve as resource to clinical research site monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
Review lIT proposals and publications, as requested.
Contribute to global alignment of Phase 3b/4 clinical studies (and Phase I and II studies where applicable) planned by country(ies) or global Development and Medical Affairs teams.
Understand and actively address the scientific information needs of all investigators and personnel.
Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.
Regulatory Support Activities
Participate in development and review of local labeling and labeling modifications in collaboration with global Development, brand teams, regulatory, and legal. Demonstrate deep knowledge of local label. Provide medical expertise to regulatory scientists.
Support I assist in the preparation of regulatory reports, preparation for regulatory agency advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from an affiliate/country perspective.
Participate in advisory committees.
Participate in risk management planning along with global Development team(s), business unit, local area, and Global Patient Safety (GPS).
Scientific / Technical Expertise and continued development
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).
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.
Explore and take advantage of opportunities for extramural scientific experiences.
Attend, contribute and participate in medical congresses/scientific symposia.
General Responsibilities
Support the business unit management team, including medical leadership in preparation and administration of the local or business unit medical budget.
Use knowledge of specific disease states and available treatments to provide scientific and medical input, contribute to the development, review, and approval of promotional and medical materials ensuring high integrity and quality.
Actively set and meet individual professional development goals and contribute to the development of others by being an active source of coaching and feedback to co-workers, and direct reports as applicable.
Collaborate proactively and productively with all alliance, business, and vendor partners.
Participates in active coaching by providing timely and constructive feedback to co-workers, others on the clinical medical team, in the spirit of development, increased team effectiveness and cohesiveness.
Actively participate in recruitment, diversity, and retention and hiring efforts as applicable.
Participate in committees, Six Sigma initiatives and task forces as requested by business unit/corporate management.
Model the leadership behaviors.
Be an ambassador of both patients and the Lilly Brand.
Minimum Qualification Requirements:
PhD with 3+ years of industry experience) OR (BS Degree or equivalent experience in Health-related field with 10+ years' industry experience
Clinical trial experience in drug discovery Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs)
Other Information/Additional Preferences:
Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership 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
Primary internal interactions include, but not limited to:
Therapeutic area directors, managers, or project managers
Product directors, managers, and associates of the brand
Clinical research 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, clinical research 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
Disease advocates and lay organizations focused on relevant health issues
Formulary representatives (private and government)
Demonstrates the following competencies
Making Business Decisions with data - Harnesses the power of data and analytics to solve problems, make good decisions and measure results.
Job-Based Skills:
Defines the problem or decision to be made within context of strategy or goals/objectives.
Identifies relevant sources and validates accuracy of data.
Analyzes and synthesizes data and identifies trends.
Draws conclusions and makes timely, well-informed decisions.
Engages data and analytics colleagues appropriately when needed.
Scientific/Information Exchange - Maximizes engagement with key customers and colleagues through the integration of personal and/or non-personal channels when collaborating, discussing, and sharing science/information.
Job-Based Skills:
Identifies challenges, information gaps, education needs, and delivery preferences.
Creates an engaging narrative.
Generates content with the channel(s) and medium(s) in mind.
Adjusts style and tone to meet the unique needs of each audience.
Uses preferred channel(s) to deliver at the time of need.
Measures knowledge gained.
Technical/Functional Expertise - Leads with technical and functional expertise.
Job-Based Skills:
Establishes appropriate scientific and medical subject matter expertise (e.g., disease states, therapeutic landscapes, drug development processes, portfolio, etc.).
Maintains relevant knowledge of the healthcare landscape (e.g., health, payer, and regulatory systems and processes) and environment (e.g., HCP experience models and patient flow maps, value/accountable care, and population health landscape, etc.).
Understands the advancements in technology that are influencing area of expertise and function (i.e., real-world clinical practice, AI techniques, tools and platforms).
Develops appropriate knowledge of activities that can be used to influence and deliver on organizational purpose (i.e., shape clinical practice, systems, tools and platforms).
Masters individual workstream tools and processes.
Strategic Agility - Defines and commits to an initial strategy or approach; monitors effectiveness; and adapts based on new information and/or insights.
Job-Based Skills:
Develops an actionable strategy or approach-involving colleagues and engaging stakeholders appropriately.
Creates a clearly defined measurement plan with key metrics and triggers.
Monitors progression and impact against key metrics.
Identifies opportunities to improve.
Reassesses strategy/approach and pivots when appropriate.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $244,200
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
Auto-ApplyClinical Research Coordinator - Level 2
Clinical research associate job in Knoxville, TN
CRC Level I - Knoxville, TN (Onsite)
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
We have an incredible opportunity for a Clinical Research Coordinator 2 to join ICON's Accellacare team. The CRC 2 ensures the safety of our volunteers, promotes the mission of Accellacare, and strives to meet and exceed study priorities. This individual is responsible for recruiting and promoting our service to suitable participants and sponsor representatives. Additionally, the CRC 2 will autonomously perform tasks required to coordinate and complete multiple studies according to the protocol. They will assist the Manager of Clinical Operations and Senior CRCs with staff development through mentoring and site level quality assurance.
This role is with Accellacare, part of ICON's clinical research network, where you'll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site network is designed with one goal in mind: to deliver better access, greater efficiency, and improved outcomes in clinical research.
Location: Onsite (1200 Merchant Drive, Knoxville, TN 37912)
What you will be doing:
Performs study start-up duties including the production of a recruitment tool, and progress notes, as well as phone screening patients and identifying participants for trials on site
Proactively develops and executes recruitment plans that meet and exceed enrollment goals
Performs study start-up duties including the production of a recruitment plan, recruitment tool, and progress notes, as well as phone screening participants.
Completes training on Clinical Trial Management System and maintains proper skills to update database, complete participant reimbursement, capture referral source of participants, and create calls lists to promote recruitment.
Attends investigator meetings
Creates and updates source documents/progress notes and utilizes templates provided in the Core Operating Guidelines
Accurately collects study data via source documents/progress notes as required by the protocol
Performs technical requirements of the study protocol, i.e., lab work (phlebotomy and processing), blood pressure, electrocardiograms, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol
Performs continuous reviews of the inclusion and exclusion criteria for each participant during the trial for their trials as well as peer review of inclusion and exclusion for trials
Documents laboratory data and adverse reactions, presents this information to an investigator in a timely manner, and immediately notifies investigators, the Institutional Review Board and sponsor of any serious adverse events
Builds and maintains strong relationships with Investigators and provides ongoing communication about trial status and participants
Dispenses study medication at the direction of the Investigator
Maintains communication with the monitor from the sponsoring company through telephone contact, written communication and on-site visits
Enters visit data in the Electronic Data Capture (EDC) or Case Report Forms (CRF) within timelines provided by sponsor
Your Profile:
2+ years of patient-facing Clinical Research Coordinator experience
Strong attention to detail
Motivated about a career in clinical research
Excellent time management and planning skills with an organized approach to work
Bachelor's degree in life sciences or other related field
#LI-Office
#LI-TP1
#LI-Accellacare
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
Auto-ApplyClinical Research Coordinator II
Clinical research associate 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 into 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 clinical research 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 Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research 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 Clinical Research Coordinator experience required
Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator
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, IN clinic.
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
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: ********************************
Clinical Research Coordinator I
Clinical research associate job in South Bend, IN
Our clinical research company is looking to hire a qualified candidate for the full-time position of Clinical Research Coordinator. 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 clinical research 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 clinical research 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.
Dr. Baessler's Clinic Roomer (Certified Medical Assistant)
Clinical research associate job in Zionsville, IN
Job Description
The Float/Roomer is responsible for making patients feel comfortable during the visit, directing patients while in the clinic, and performing initial assessment and intake of information including, but not limited to, past surgical, medical, family and social history, taking and recording patient vital signs, and interviewing patient to fully understand the reason for the visit. Individuals in this role will provide care for clinic patients following established standards and practices. This individual is responsible for delivering patient care and assisting in procedures as directed by physicians. This position is responsible for maintaining and updating patients records with a high degree of accuracy in a timely and efficient manner.
Type: Full Time
Location: Fishers, IN office
Travel Required: 1 day a week to Zionsville, IN and Fishers, IN
Prepares patients for examination and treatment by observing, recording, and assessing patient's condition, noting reactions to drugs and treatments, obtaining vital signs, and taking patient's past surgical, medical, social, and family history and accurately entering information into the electronic health record.
Updates and maintains patient files, records, posts tests and examination results, formulates and updates patient care plans, and other information with a high degree of accuracy and efficiency to provide a smooth and timely flow of patients through the clinic.
Performs selected nursing duties, including assisting physicians in preparing for minor surgeries, procedures and physicals; assisting physician during treatment as needed; obtain specimens and administer injections or tests as ordered by physician, arranging for additional testing as needed, and apply or remove casts, splints, and dressings as necessary.
Explain and demonstrate home physical therapy exercises or rehabilitation techniques to patients.
Prepares exam and treatment rooms with necessary instruments based on physician and patient needs.
Maintains and prepares supplies and equipment for treatments, including sterilization and ensuring clinic area is stocked with proper equipment at all times and ordering as necessary.
Places a high priority on and maintains strict confidentiality in all situations.
Participates in professional development activities and maintains applicable professional affiliations and certifications as required.
Attends and participates in required organizational meetings and committees as requested.
Perform additional related duties as assigned.
Education, Experience, and Certification/License Requirements:
Completion of an accredited program medical assisting (Associate's degree). One to two years' professional experience in a clinical setting preferred. Must possess and maintain in good standing certification from the American Association of Medical Assistants (CMA or CCMA). Must maintain current BLS certification.
Working Conditions/Physical Requirements:
Working environment is in a clinical environment. Exposure to communicable diseases, toxic substances, ionizing radiation, medicinal preparations and other conditions common to a clinic environment. Work requires standing for long periods of time and excessive walking. Position requires full range of body motion including handling and lifting/assisting patients, manual and finger dexterity and eye-hand coordination. Occasionally lifts and carries items weighing up to 100 pounds. Requires normal visual acuity and hearing must be in normal range for telephone contacts and to interact directly with patients. Regularly interacts with staff, physicians, and the public, which may involve dealing with angry or upset people. Work may be stressful at times.
Clinical Research Associate II
Clinical research associate job in Nashville, TN
Responsible for providing Clinical Research 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 clinical research 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 clinical research 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 and 401K
Dr. Baessler's Clinic Roomer (Certified Medical Assistant)
Clinical research associate job in Anderson, IN
Job Description
The Float/Roomer is responsible for making patients feel comfortable during the visit, directing patients while in the clinic, and performing initial assessment and intake of information including, but not limited to, past surgical, medical, family and social history, taking and recording patient vital signs, and interviewing patient to fully understand the reason for the visit. Individuals in this role will provide care for clinic patients following established standards and practices. This individual is responsible for delivering patient care and assisting in procedures as directed by physicians. This position is responsible for maintaining and updating patients records with a high degree of accuracy in a timely and efficient manner.
Type: Full Time
Location: Fishers, IN office
Travel Required: 1 day a week to Zionsville, IN and Fishers, IN
Prepares patients for examination and treatment by observing, recording, and assessing patient's condition, noting reactions to drugs and treatments, obtaining vital signs, and taking patient's past surgical, medical, social, and family history and accurately entering information into the electronic health record.
Updates and maintains patient files, records, posts tests and examination results, formulates and updates patient care plans, and other information with a high degree of accuracy and efficiency to provide a smooth and timely flow of patients through the clinic.
Performs selected nursing duties, including assisting physicians in preparing for minor surgeries, procedures and physicals; assisting physician during treatment as needed; obtain specimens and administer injections or tests as ordered by physician, arranging for additional testing as needed, and apply or remove casts, splints, and dressings as necessary.
Explain and demonstrate home physical therapy exercises or rehabilitation techniques to patients.
Prepares exam and treatment rooms with necessary instruments based on physician and patient needs.
Maintains and prepares supplies and equipment for treatments, including sterilization and ensuring clinic area is stocked with proper equipment at all times and ordering as necessary.
Places a high priority on and maintains strict confidentiality in all situations.
Participates in professional development activities and maintains applicable professional affiliations and certifications as required.
Attends and participates in required organizational meetings and committees as requested.
Perform additional related duties as assigned.
Education, Experience, and Certification/License Requirements:
Completion of an accredited program medical assisting (Associate's degree). One to two years' professional experience in a clinical setting preferred. Must possess and maintain in good standing certification from the American Association of Medical Assistants (CMA or CCMA). Must maintain current BLS certification.
Working Conditions/Physical Requirements:
Working environment is in a clinical environment. Exposure to communicable diseases, toxic substances, ionizing radiation, medicinal preparations and other conditions common to a clinic environment. Work requires standing for long periods of time and excessive walking. Position requires full range of body motion including handling and lifting/assisting patients, manual and finger dexterity and eye-hand coordination. Occasionally lifts and carries items weighing up to 100 pounds. Requires normal visual acuity and hearing must be in normal range for telephone contacts and to interact directly with patients. Regularly interacts with staff, physicians, and the public, which may involve dealing with angry or upset people. Work may be stressful at times.