Clinical research coordinator jobs in Battle Creek, MI - 278 jobs
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Clinical Coordinator: 6 Medical
Akron Children's Hospital 4.8
Clinical research coordinator job in Akron, OH
6 Medical
Full Time 36 hours/week
Nights 7p-730a
Onsite
Assists manager in the daily operations at the unit level, in collaboration with interdisciplinary teams. Assesses, plans, implements, and evaluated delivery of patient care on assigned unit and shift. Contributes to development and evaluations of assigned nursing personnel. Assists and provides nursing care utilizing specialized knowledge, judgement and skill.
Responsibilities:
1. Provides leadership and direction regarding unit goals and work environment by assisting nurse manager in his/her duties.
2. Demonstrates personal and professional accountability for self and staff.
3. Maintains unit safety for staff and patients.
4. Participates in performance improvement.
5. Participates in and supports staff recruitment and retention efforts.
6. Uses critical thinking to provide patient care management through staffing plan development, managing daily shift staffing, and delegation of resources.
7. Supports and assists within human resource management, including but not limited to coaching, time keeping, development and evaluation of nursing personnel.
8. Supports patient care and staffing needs throughout the Akron Children's Hospital enterprise.
9. Promotes a positive work environment and staff engagement.
10. Serves as a clinical resource to the interdisciplinary team.
11. Demonstrates the knowledge and skills necessary to provide care for the physical, psychological, social, educational and safety needs of the patients served.
12. Other duties as required.
Other information:
Technical Expertise
1. Proficiency in MS Office [Outlook, Excel, Word] or similar software is required.
2. Valid Ohio license.
3. Current Health Care Provider BLS training from the American Heart Association is required.
4. See the Department of Nursing Resuscitation Requirements and training policy #2102 for specific department requirements.
5. Relevant professional nursing certification, preferred.
Education and Experience
1. Education: Graduate from an accredited School of Nursing, BSN required, or current enrollment in a BSN program with program completion required within 2 years of assuming position.
2. Certification: May differ based on department/unit
3. Years of experience: Minimum two years relevant clinical experience with demonstrated management and leadership abilities is required.
4. Years of experience supervising: Previous charge nurse or other leadership experience is required.
5. Strong leadership skills including communication/organizational skills, time management, coping skills, motivation, problem solving, autonomy, and supporting teams is required.
Full Time
FTE: 0.900000
Status: Onsite
$42k-53k yearly est. 19d ago
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Oncology Clinical Research Coordinator
Actalent
Clinical research coordinator job in Detroit, MI
This role involves working directly with patients and conducting patient visits. The ClinicalResearchCoordinator will collaborate closely with research nurses and will have the support of Data and Regulatory teams. While a basic understanding of these functions is required, the Coordinator will not be responsible for them. The position involves working within teams divided by disease group, potentially including Phase 1 clinical trials.
Responsibilities
Conduct patient visits and work directly with patients.
Collaborate with research nurses as needed during patient visits.
Participate in recruitment activities using methods such as referrals, tumor board, and new consults.
Conduct chart reviews to support studies.
Support all studies within the team, without owning or leading any specific study.
Manage a patient load of no more than 10 patients a week, with patient visits varying by team and study phase.
Essential Skills
At least one year of clinical trial experience, including patient-facing roles, consenting patients, and conducting patient visits.
Experience in oncology or other complex therapeutic area.
Bachelor's Degree.
Experience with Phase 1 clinical trials.
Job Type & Location
This is a Contract to Hire position based out of Detroit, MI.
Pay and Benefits
The pay range for this position is $27.00 - $35.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in Detroit,MI.
Application Deadline
This position is anticipated to close on Jan 30, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
$27-35 hourly 3d ago
Clinical Research Coordinator
SQRL
Clinical research coordinator job in Columbus, OH
Highlights
$55,000 - $70,000 salary based on experience and certifications
Consistent schedule M-F, no overnights or weekends
Work with a company that truly cares about their employees and patients
About Our Client
Our client is a long standing clinicalresearch site in the Columbus, OH area that takes a truly unique patient-centric, service-oriented, approach to clinicalresearch. Their reputation for excellence has been built across over 20 therapeutic areas, over 15 physicians, and over 550 completed trials! They are looking to expand their team with a skilled clinicalresearchcoordinator!
Responsibilities
As a CRC you will be a specialized research professional under the direction of the clinical Principal Investigator and Site Manager. While the PI and Site Manager are responsible for the overall design, conduct, and management of the clinical trial, you support, facilitate, and coordinate the daily clinical trial activities and play a critical role in the conduct of the study including supporting patients throughout the clinical trial process!
Conduct procedures such as vital signs, blood draws, EKGs, and bladder scans.
Patient recruitment, enrollment, scheduling, and consent
Lab procedures and shipments
Maintain GCP and follow protocols
Data management in EDC systems
Overall coordination of the study
Qualifications:
Clinicalresearch experience as a Research Assistant OR as a CRC
Phlebotomy and lab processing experience (ability to perform without supervision)
Ability to work on site M-F on site (there is no remote or hybrid days)
$55k-70k yearly 2d ago
Research Nurse Coordinator - HVTI
Cleveland Clinic 4.7
Clinical research coordinator job in Cleveland, OH
Join Cleveland Clinic's Main Campus where research and surgery are advanced, technology is leading-edge, patient care is world class and caregivers are family. Here, you will work alongside a passionate and dedicated team, receive endless support and appreciation, and build a rewarding career with one of the most respected healthcare organizations in the world.
Innovative research and groundbreaking discoveries happen every day at Cleveland Clinic. Each member of our team contributes to our mission of caring for life, analyzing health and educating caregivers. As a Research Nurse Coordinator for HVTI research, you will help us achieve this goal by overseeing the implementation and conduct of various human subject research projects. In this role, you will use your nursing knowledge to perform a variety of related tasks, including care plan development, condition evaluations, telephone triage, documentation and more.
A caregiver in this role works days from 8:00 a.m. - 4:30 p.m. (start/end times flexible)
After six months of orientation, there is an opportunity to work remotely one day per week.
A caregiver who excels in this role will:
Coordinate the implementation and conduct of research projects, ensuring adherence to research protocol requirements and timely completion.
Complete and communicate regulatory documents, develop data and monitoring plans, report Serious Adverse Events as they occur, and complete FDA and sponsor forms.
Serve as a liaison between investigators, research personnel, outside study personnel, and central research administration offices to assist in protocol interpretation, enrollment, and safety questions.
Assess research subjects, complete nursing assessments, document findings in research subject records, and notify the physician of abnormal findings.
Establish a care plan in collaboration with the research subject, family, and research team, and coordinate ongoing care.
Identify discharge needs and facilitate discharge planning as appropriate.
Perform telephone triage, nursing procedures, and treatments.
Evaluate, initiate, and maintain standards of care consistent with CCHS policies and procedures.
Assist with specialized patient care equipment as required by the clinicalresearch protocol.
Administer medications and treatments as ordered by a physician or licensed independent provider (LIP).
Direct, coordinate, and participate in the evaluation and supervision of nursing care provided to research subjects, establishing patient care priorities and delegating nursing activities according to patient needs and staff capabilities.
Conduct and document the informed consent process.
May assist PI with research study design and development of the research protocol.
May assist with research project budget development.
Minimum qualifications for the ideal future caregiver include:
Graduate from an accredited school of professional nursing
Current state licensure as a Registered Nurse (RN)
Basic Life Support (BLS) Certification through the American Heart Association (AHA) or American Red Cross
Four years of clinical experience
Two years of research experience
Understanding of the research process and terminology
In-depth knowledge of the specialty under investigation
Working knowledge of federal regulations and good clinical practice (GCP)
Meet clinical competency requirements
Preferred qualifications for the ideal future caregiver include:
Bachelor's of Science in Nursing (BSN)
Computer acumen (Outlook, Excel, research databases)
Knowledge and/or experience in the OR
Physical Requirements:
Requires full range of body motion, manual and finger dexterity, and eye-hand coordination.
Requires standing and walking for extended periods of time.
Requires corrected vision and hearing to normal range.
Requires working under stressful conditions and irregular hours.
Exposure to communicable diseases and/or body fluids.
Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. Physical Demand requirements are in excess of those for Light Work.
Personal Protective Equipment:
Follows standard precautions using personal protective equipment as required.
Pay Range
Minimum Annual Salary: $63,250.00
Maximum Annual Salary: $96,467.50
The pay range displayed on this job posting reflects the anticipated range for new hires. A successful candidate's actual compensation will be determined after taking factors into consideration such as the candidate's work history, experience, skill set and education. The pay range displayed does not include any applicable pay practices (e.g., shift differentials, overtime, etc.). The pay range does not include the value of Cleveland Clinic's benefits package (e.g., healthcare, dental and vision benefits, retirement savings account contributions, etc.).
$63.3k-96.5k yearly 6h ago
Director - Clinical Research Scientist - Global and US Medical Affairs
Eli Lilly and Company 4.6
Clinical research coordinator job in Indianapolis, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Organization Overview
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Summary
The ClinicalResearch Scientist (CRS) within the Business Unit - Medical Affairs provides scientific and clinical expertise to support product strategy and execute medical plan tactics, customer engagement, and evidence generation. This role ensures that medical insights, clinical data, and regulatory considerations are effectively integrated into local business activities and global development plans.
Key Responsibilities
1. Business & Customer Support
Anticipate and respond to scientific and clinical information needs from healthcare providers, payers, and patient groups.
Lead data analyses and health outcomes research to address customer questions.
Contribute to medical strategy and brand planning in collaboration with global Medical Affairs, GPO/RWE, PRA, and commercial partners.
Provide medical expertise for payer partnerships, promotional material review, and business‑to‑business/government engagements.
Support training of sales, medical, and patient support teams.
Lead definition of Patient Journey and contribute clinical perspective to patient programs.
Participate in relevant professional and industry associations.
2. Scientific Exchange & Data Dissemination
Ensure compliance with global and local regulations governing scientific communication.
Address unsolicited scientific inquiries in alignment with medical governance standards.
Support scientific meetings, advisory boards, symposia, and other expert engagements.
Prepare or review medical letters, slide decks, abstracts, posters, and manuscripts.
Build and maintain relationships with key opinion leaders and scientific societies.
Represent the company at medical congresses and support scientific booth activities.
Contribute to data analyses, publication development, and Clinical Trial Registry reporting.
3. Clinical Planning
Align clinical strategies with regional needs by collaborating with Medical Affairs and global development teams.
Communicate local research needs to ensure Phase I-IV programs reflect market and customer requirements.
Maintain up‑to‑date understanding of clinical and competitive data.
Provide regional clinical insights to inform development plans and study protocols.
4. ClinicalResearch Execution
Review and approve informed consent documents to ensure accurate risk communication.
Partner with clinical operations, statisticians, and investigators throughout study design, initiation, conduct, and close‑out.
Support investigator/site training and address study‑related medical questions.
Oversee local safety monitoring and adverse event follow‑up.
Review investigator‑initiated trial (IIT) proposals as needed.
Ensure global alignment of Phase 3b/4 and applicable early‑phase studies.
5. Regulatory Support
Contribute to development and review of local labeling and labeling changes.
Provide medical input for regulatory submissions, advisory committee preparation, and local registration activities.
Participate in risk management planning with global and local teams.
6. Scientific & Professional Development
Stay informed on therapeutic area trends, market changes, and competitive landscape.
Provide scientific training to clinical study teams and act as a protocol subject‑matter expert.
Represent the organization at medical congresses and contribute to medical budget planning.
Seek opportunities for external scientific engagement.
7. Leadership & Collaboration
Set and pursue professional development goals and support growth of colleagues and direct reports.
Contribute to recruitment, diversity, and retention efforts when applicable.
Participate in committees, Six Sigma initiatives, and cross‑functional projects.
Model leadership behaviors and serve as an ambassador for patients and the company.
Basic Qualifications
An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 10 years experience and at least 1 year of gastroenterology pharmaceutical experience
Additional Preferences
Clear evidence and documentation of candidate's direct role and contribution to medical content. This should include evidence of candidate as medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical content = medical, scientific or clinical information)
Ability to balance scientific priorities with business priorities with examples of successful leadership skills
Demonstrate strong communication, interpersonal, teamwork, organizational and negotiation skills
Demonstrate ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.
Fluent in English, verbal and written communication
Primary internal interactions include, but not limited to:
Therapeutic area directors, managers, or project managers
Product directors, managers, and associates of the brand
Clinicalresearch staff
Statisticians
Scientific communication associates
Medical information associates
Medical liaisons
Global patient outcomes research consultants/research scientists and health outcomes liaisons
Regulatory directors, scientists, and associates
Sales representatives
Legal counsel
Therapeutic area physicians, global brand physicians, early phase physicians, clinicalresearch scientists, and Regional Medical Leader, Directors-Medical.
Corporate or regional patient safety physician(s)
External Contacts
Scientific and clinical experts, thought leaders
Lilly clinical investigators
Practicing physicians/prescribers
Regulatory agency personnel
Professional association staff and leaders
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$177,000 - $308,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$177k-308k yearly Auto-Apply 13d ago
Lead Clinical Research Associate
Oracle 4.6
Clinical research coordinator job in Lansing, MI
With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to join us!
As a global leader we're looking for a Senior **Lead ClinicalResearch Associate (CRA)** to drive success as part of our Non-interventional Study team.
Join Oracle as a Lead CRA and make a real impact by guiding teams, ensuring top-quality clinicalresearch, and driving groundbreaking projects on a global scale!
**What you will do**
**As a Senior Lead ClinicalResearch Associate at Oracle, you will:**
+ **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors.
+ **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters.
+ **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents.
+ **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans.
+ **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of ClinicalResearch Associates, develop project-specific training materials, and ensure delivery of high-quality site management.
+ **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports.
+ **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement.
+ **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required.
**Required Experience**
+ **Education** : Bachelor's degree in Life Sciences, Medical Science, Pharmacy, Public Health, or equivalent, with a minimum of three years' hands-on clinicalresearch experience.
+ **Clinicalresearch expertise** : At least 3 years of experience as a CRA, including site initiation, Trial Master File (TMF) management, and site monitoring for both clinical and non-interventional studies.
+ **Communication skills** : Outstanding spoken and written proficiency in English (C1 level minimum).Additional languages are considered a strong asset.
+ **Technical proficiency** : Comfort with MS Office, EDC, CTMS exprience and willingness to learn and handle various technical systems and tools.
+ **Personal qualities** : Exceptional organizational and problem-solving skills, strong cross-culturalteamwork, initiative in process optimization, and the ability to manage competing priorities in a fast-paced environment.
+ **Financial management:** Experience reviewing site contracts, budget and invoices.
+ **Attention to detail** : Ability to work independently with careful, precise, and thorough execution of complex tasks.
**Responsibilities**
**What you will do**
**As a Senior Lead ClinicalResearch Associate at Oracle, you will:**
+ **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors.
+ **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters.
+ **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents.
+ **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans.
+ **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of ClinicalResearch Associates, develop project-specific training materials, and ensure delivery of high-quality site management.
+ **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports.
+ **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement.
+ **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required.
Disclaimer:
**Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.**
**Range and benefit information provided in this posting are specific to the stated locations only**
US: Hiring Range in USD from: $70,600 to $141,200 per annum. May be eligible for bonus and equity.
Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business.
Candidates are typically placed into the range based on the preceding factors as well as internal peer equity.
Oracle US offers a comprehensive benefits package which includes the following:
1. Medical, dental, and vision insurance, including expert medical opinion
2. Short term disability and long term disability
3. Life insurance and AD&D
4. Supplemental life insurance (Employee/Spouse/Child)
5. Health care and dependent care Flexible Spending Accounts
6. Pre-tax commuter and parking benefits
7. 401(k) Savings and Investment Plan with company match
8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation.
9. 11 paid holidays
10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours.
11. Paid parental leave
12. Adoption assistance
13. Employee Stock Purchase Plan
14. Financial planning and group legal
15. Voluntary benefits including auto, homeowner and pet insurance
The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted.
Career Level - IC3
**About Us**
As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity.
We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all.
Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.
We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_************* or by calling *************** in the United States.
Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
$70.6k-141.2k yearly 11d ago
Clinical Scientist
Eliassen Group 4.7
Clinical research coordinator job in Lansing, MI
**Anywhere** **Type:** Permanent **Category:** Clinical Ops **Industry:** Life Sciences **Workplace Type:** Remote **Reference ID:** JN -112025-104407 **Shortcut:** ********************************** + Description + Recommended Jobs
**Description:**
_Remote_
Our client is a PE-backed medical device organization advancing next-generation technologies in atrial fibrillation and cardiac ablation. As the team prepares for two global Class III IDE studies, the Clinical Development and Science function is expanding to support protocol development, safety oversight, and scientific leadership. The role provides exposure to electrophysiology and Pulse Field Ablation, contributing to the scientific, clinical, and strategic elements of cardiac ablation innovation.
_This is a full-time, permanent opportunity, offering a competitive salary and comprehensive benefits package. Qualified applicants must be willing and able to work on a w2 basis._
Salary: $130,000 - $150,000/ yr. w2
**Responsibilities:**
**Responsibilities**
+ Lead development of clinical study protocols, case report forms, and associated study documents.
+ Support clinical safety oversight, including adverse event review, vigilance, and coordination with the Clinical Events Committee.
+ Contribute scientific input into study design, endpoints, and overall clinical strategy.
+ Review and interpret clinical data to support study reports, publications, and regulatory submissions.
+ Collaborate closely with Clinical Operations, Field Clinical, Regulatory, and Quality teams.
+ Participate in discussions with key opinion leaders, investigator meetings, and internal scientific reviews.
+ Ensure scientific consistency across programs and alignment with regulatory and clinical goals.
+ Support the development of data collection tools and ensure clarity, accuracy, and completeness.
+ Assist with medical writing elements related to clinical reports and study documentation.
**Experience Requirements:**
**Experience Requirements**
+ Electrophysiology and Pulse Field Ablation experience required.
+ Background supporting clinical studies in industry or academia.
+ Strong understanding of clinicalresearch methods and safety reporting.
+ Ability to evaluate and interpret clinical data.
+ Strong scientific writing skills and attention to detail.
+ Ability to collaborate effectively across Clinical Development, Operations, and Regulatory functions.
+ Excellent communication and analytical capabilities.
+ Prior experience as a Clinical Scientist in medical devices preferred.
+ Experience with Class III devices or IDE studies preferred.
+ Experience contributing to regulatory submissions or interacting with health authorities preferred.
+ Experience working with electrophysiologists, key opinion leaders, or clinical event committees preferred.
**Education Requirements:**
**Education Requirements**
+ MS, PhD, or MD.
**_Recruitment Transparency Notice_**
**_Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (_** **_noreply@eliassen.com_** **_, ************* inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process._**
_Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range._
_W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality._
_Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact_ _********************_ _._
_About Eliassen Group:_
_Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate._
_Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status._
_Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!_
Clinical research coordinator job in Indianapolis, IN
ICON plc is a world-leading healthcare intelligence and clinicalresearch 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
What will you be doing?
Works on multiple trials within the Cross Therapeutic areas - Start up focus
Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements.
Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies.
Build strong relationships with site personnel to facilitate a smooth onboarding process.
Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs).
Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation.
Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process.
Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities.
Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones.
Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines.
Proactively identify and address any issues that may delay study initiation or affect trial deliverables.
Maintain precise documentation to ensure readiness for inspections.
Support sites during the activation phase until they achieve “Green Light” status for site opening.
Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met.
Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards.
What do you need to have?
Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
Must be located in Columbus, OH area; near a major airport.
Must have 2 -3 years' experience in monitoring pharmaceutical industry clinical trials
Have a minimum of 1-3 years' experience monitoring cross therapeutic area clinical trials
Knowledge of several therapeutic areas
Analytical/risk-based monitoring experience is an asset
Ability to actively drive patient recruitment strategies at assigned sites
Ability to partner closely with investigator and site staff to meet all of our study timelines
Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.
Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
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
Clinical research coordinator job in Indianapolis, IN
ICON plc is a world-leading healthcare intelligence and clinicalresearch 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
What will you be doing?
Works on multiple trials within the Cross Therapeutic areas - Start up focus
Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements.
Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies.
Build strong relationships with site personnel to facilitate a smooth onboarding process.
Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs).
Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation.
Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process.
Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities.
Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones.
Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines.
Proactively identify and address any issues that may delay study initiation or affect trial deliverables.
Maintain precise documentation to ensure readiness for inspections.
Support sites during the activation phase until they achieve “Green Light” status for site opening.
Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met.
Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards.
What do you need to have?
Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
Must be located in Columbus, OH area; near a major airport.
Must have 2 -3 years' experience in monitoring pharmaceutical industry clinical trials
Have a minimum of 1-3 years' experience monitoring cross therapeutic area clinical trials
Knowledge of several therapeutic areas
Analytical/risk-based monitoring experience is an asset
Ability to actively drive patient recruitment strategies at assigned sites
Ability to partner closely with investigator and site staff to meet all of our study timelines
Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.
Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
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
$52k-83k yearly est. Auto-Apply 5d ago
Clinical Research Associate 1
Allen Spolden
Clinical research coordinator job in Indiana
Responsible for providing ClinicalResearch support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinicalresearch functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1 -2 years of clinicalresearch experience or equivalent experience or training
Strong attention to detail
Ability to multi -task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self -motivated, assertive, and driven
BenefitsDental, Medical, Vision, PTO and 401K
ICON plc is a world-leading healthcare intelligence and clinicalresearch 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.
What will you be doing?
* Works on multiple trials within the Cross Therapeutic areas - Start up focus
* Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements.
* Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies.
* Build strong relationships with site personnel to facilitate a smooth onboarding process.
* Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs).
* Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation.
* Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process.
* Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities.
* Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones.
* Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines.
* Proactively identify and address any issues that may delay study initiation or affect trial deliverables.
* Maintain precise documentation to ensure readiness for inspections.
* Support sites during the activation phase until they achieve "Green Light" status for site opening.
* Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met.
* Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards.
What do you need to have?
* Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
* Must be located in Columbus, OH area; near a major airport.
* Must have 2 -3 years' experience in monitoring pharmaceutical industry clinical trials
* Have a minimum of 1-3 years' experience monitoring cross therapeutic area clinical trials
* Knowledge of several therapeutic areas
* Analytical/risk-based monitoring experience is an asset
* Ability to actively drive patient recruitment strategies at assigned sites
* Ability to partner closely with investigator and site staff to meet all of our study timelines
* Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
* Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.
* Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
* To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized 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
$43k-62k yearly est. 4d ago
Clinical Scientist- FSP
Parexel 4.5
Clinical research coordinator job in Lansing, MI
PXL is hiring a Clinical Scientist! **Job Purpose:** The Clinical Scientist (CS) assists the CS Protocol Lead and study team with the clinical/scientific conduct of clinical studies (e.g., adjudication support, medical monitoring, imaging data reconciliation preparation of meeting materials, protocol deviation management).
**Key Accountabilities**
May include but not limited to the following:
Clinical Trial Operational Delivery
- May support a single study or multiple studies
- May lead a study with limited scope (e.g., Survival Follow-up)
- Liaises with cross-functional lines as appropriate
- May interact with internal and external stakeholders (study sites,
committees, etc.) in support of clinical study objectives
Compliance with Parexel Standards
- Complies with required training curriculum
- Completes timesheets accurately as required
- Submits expense reports as required
- Updates CV as required
- Maintains a working knowledge of and complies with Parexel processes,
ICH-GCPs and other applicable requirements
Skills:
- Demonstrated oral and written communication skills
- MS Office Suite Experience Required- including Word, Excel, and Power Point
- Proficient in written and spoken English
- Proficient in local language (as applicable)
- Willingness to travel as required for key company meetings
Knowledge and Experience:
- Pharmaceutical experience beneficial but not required
- Therapeutic Area (TA) specific experience beneficial
- 2 years medical monitoring experience preferred
Education:
- Bachelors/Masters/PhD in Life Sciences with 2+ years relevant career experience
- If no degree in Life Sciences, must have significant experience in clinical development (>5 years)
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$99k-124k yearly est. 3d ago
Study Start-Up Coordinator- PhD
Medpace 4.5
Clinical research coordinator job in Cincinnati, OH
Our clinical operations activities are growing rapidly, and we are currently seeking full-time, office-based Regulatory Submissions Coordinators to join our Study Start-up team. This position works both independently and collaboratively with a team to meet common goals and plays a key role in the clinical trial management and study start-up process at Medpace. We are seeking entry level employees. If you want an exciting career where you can build a foundation in industry knowledge through our robust training program and develop and grow your career even further, then this is the opportunity for you.
Responsibilities
* Communicate with research sites (doctor's offices, universities, hospitals, etc.) to collect all essential documents required before the site begins to screen patients to participate in the clinical trial;
* Maintain and perform ongoing quality review of trial documents within the Trial Master File (TMF);
* Collect, review, organize, and assemble regulatory start-up submissions (including submissions to Institutional Review Boards (IRB);
* Maintain timelines for study start-up through both internal and external collaboration; and
* Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.
SITE ACTIVATION & MAINTENANCE (SAM) TRAINING PROGRAMMedpace training programs are curated to educate and support experienced associates, as well as those that are new to the industry. The SAM Training Program embraces evidence- based learning & development models to advance professional learning and employee performance. In the program, you will…• Complete independent learning modules, interactive exercises, and team workshops through the core curriculum;• Gain exposure to real-world tasks through a robust mentoring program; and• Join other professionals revolutionizing efficient and seamless study start-up to advance clinical trials.
Qualifications
* A minimum of a PhD is required (preferably in a Life Sciences field);
* 3.5 GPA and above preferred;
* Some experience in an office setting is preferred;
* Excellent organizational and prioritization skills;
* Knowledge of Microsoft Office; and
* Great attention to detail and excellent oral and written communication skills.
Travel: None
Medpace Overview
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Cincinnati Perks
* Cincinnati Campus Overview
* Flexible work environment
* Competitive PTO packages, starting at 20+ days
* Competitive compensation and benefits package
* Company-sponsored employee appreciation events
* Employee health and wellness initiatives
* Community involvement with local nonprofit organizations
* Discounts on local sports games, fitness gyms and attractions
* Modern, ecofriendly campus with an on-site fitness center
* Structured career paths with opportunities for professional growth
* Discounted tuition for UC online programs
Awards
* Named a Top Workplace in 2024 by The Cincinnati Enquirer
* Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
* Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
$45k-61k yearly est. Auto-Apply 15d ago
Study Coordinator II BioA
Labcorp 4.5
Clinical research coordinator job in Greenfield, IN
We have an excellent opportunity for a Study Coordinator I on our BioAnalytical Team in Greenfield, IN. Labcorp Drug Development's work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career.
In this role, you will be coordinating the activities of routine and non-routine studies in compliance with appropriate company standards, GLP, GCP, GMP, and regulatory guidelines specified in the study plans, protocols, or work agreements governing the work in which they are involved in a timely, efficient, and quality manner. High volume of data and report delivery.
Essential Job Duties:
* Writes Study Protocols, Methods and Reports
* With minimal support and guidance, drafts protocols, methods, amendments, and reports; utilizing sources such as Documentum, Toxicology protocols and client supplied information
* Reviews study activities for compliance against protocol/SOW, Standard Operating Procedure (SOP), Policies, and regulatory agency guidelines.
* With support, assists Scientist with report preparation, including table and figure preparation; compiles analytical information from operations teams.
* Under direction of Scientist, supports with Quality Assurance Unit (QAU) audits of study documents, drafts responses as applicable, and follows up with appropriate personnel to ensure that all responses and/or necessary document/raw data clarifications are completed within specified timelines.
* Reviews client comments in protocol, method drafts and reports with Scientist, works with them to determine appropriate responses; addresses comments under guidance of Scientist to ensure all necessary document/data clarifications are completed in a timely manner.
* Supports report production processes through finalization
* Assists with archiving of study related materials
* Drives/Maintains Study and Client Communications
* Efficiently communicate and serve as a secondary to support the Scientist with client contact on assigned studies.
* Proactively communicates and interacts with study team, other departments, and clients as applicable.
* Attends and engages in pre-initiation and other internal study-related meetings, and attends conference calls; takes and distributes meeting minutes / action items, as appropriate.
* Support PM's and Scientists with preparing for and attends routine client visits.
* With support manages data transfer to clients as requested.
* Drives/Contributes to Process Improvement/Adherence
* Participates in the development and maintenance of standard report/table formats as needed.
* Participates in the development and maintenance of standard protocol, method and Sample Analysis Plan (SAP) formats as needed.
* Identifies opportunities to increase the efficiency of daily/routine procedures and reporting methods; provides input on and assists with implementation of new technologies, system changes, and enhancements.
* Study/Timeline Management
* With support plans, prioritizes, and manages own workload and multiple responsibilities.
* With support uses project tracking systems, as appropriate.
* Manages standard projects and study designs, and drives to increase study load over time.
* Maintains well-documented, organized, and up-to-date study files, including real-time study schedule updates, as applicable.
* Demonstrates active engagement with study progress/timelines.
* Actively promotes a team environment; identifies and escalates any activities that do not promote a team environment.
* Other related duties as assigned
Minimum Required:
* Bachelor of Science (BS) degree in science or related field preferred; experience may be substituted for education
* Ability to learn/utilize word processing software, database, spreadsheet, and specialized software
* Excellent communication and interpersonal skills
* Excellent attention to detail
* Ability to prioritize, organize, and manage time
Application Window - 1/21 thru 1/31/2026
Pay Range: $24 - $25 per hour
All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here.
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.
$24-25 hourly Auto-Apply 6d ago
Specialist, Clinical Business Operations, Oncology
Sumitomo Pharma 4.6
Clinical research coordinator job in Lansing, MI
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
**Job Duties and Responsibilities**
+ Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA).
+ Assist with the entry of Contractual Agreements into an electronic document repository.
+ Ensure all outsourcing decisions are properly documented, compliant, and audit-ready.
+ Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate.
+ Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements.
+ Perform other duties as requested.
**Key Core Competencies**
+ Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities
+ Ability to proactively identify and act on opportunities for operational efficiencies
+ Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude
+ Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution
+ Excellent written and oral communication skills
**Education and Experience**
+ BA/BS preferred with at least 2 years experience, or 5 years equivalent experience
+ Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles.
The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at **********************************************
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
$72.5k-90.6k yearly 60d+ ago
Parasitology - Clinical Research
Zoetis 4.9
Clinical research coordinator job in Kalamazoo, MI
Role Description
Manager I (Parasitology)
US Clinical Operations
Global ClinicalResearch and Development
Veterinary Medicine Research & Development (VMRD)
The successful applicant embodies Zoetis' Core Beliefs: Our Colleagues Make The Difference, Always Do The Right Thing, Customer Obsessed, Run It Like You Own It, and We Are One Zoetis.
Within US Clinical Operations, the candidate will be assigned to one or more Project Teams and will have the following duties and responsibilities:
Participate on project teams to develop and license veterinary parasiticides. As a member of the clinical team, coordinate or lead the coordination of all study activities, including start up, Investigator training, conduct, site monitoring and close out. These may include, but are not limited to:
Prepare study protocols, amendments, deviations, data capture forms, electronic data capture systems, test article documentation and study reports in preparation for submission to regulatory agencies.
Collaborate with multiple internal partner groups to plan, coordinate, conduct, analyze, and report studies.
Develop training materials and conduct training of Investigators and other study site personnel.
Coordinate animal related study activities (i.e. clinical sampling, test material administration and clinical observations).
Serve as the principal communication link between the Sponsor and study sites.
Maintain study files in accordance with SOPs and regulatory requirements.
Implement and execute data management processes including paper and electronic data capture, entry, review, tracking, and verification utilizing electronic tools and centralized data management systems.
Prepare study files, author study reports and review technical section summaries for submission to regulatory agencies (FDA, EMA, EPA).
Lead multi-functional team(s) serving as a project team member or clinical team lead.
Contribute to, review and/or author manuscripts for journal publication. Present results, as needed, both internally and to external scientific audiences.
Travel: approximately 10 - 40% on an annual basis. Variable, depending upon project status.
EDUCATION AND EXPERIENCE:
Educational Background:
Minimum: Bachelor's degree
Desirable: Master's degree
Work Experience/Skills:
Minimum:
Five years' experience as a clinical study coordinator/monitor or in research/product development in the animal health pharmaceutical industry
Experience in the study design and execution of parasitology laboratory clinical studies.
Familiarity with parasitology study designs and models as well as regulatory guidance/expectations for the conduct and execution of parasitology studies.
Previous experience with preparation of regulatory submissions for FDA, EPA and/or EMA for product registration
Previous experience working with veterinary clinics and/or research facilities.
Experience with Good Clinical Practice and/or Good Laboratory Practices.
Ability to work both as a member of a team and independently in a self-directed and self-motivated manner.
Excellent skills in the following competencies: organizing, planning, time management, quality, attention to detail.
Well-developed critical thinking skills with the ability to learn on the fly and problem solve.
Excellent interpersonal skills with very good written and oral communication skills.
Competence with Microsoft Office Products (Outlook, Word, Excel, OneNote, Teams).
Experience in configuring studies in an electronic data capture platform/ eClinical software.
Desirable:
Experience and interest in the conduct and leadership of companion animal clinical field studies.
Education and clinical experience in the field of veterinary technology.
Competence with electronic data capture, eClinical software or remote communication tools.
MS or MPS in Veterinary Parasitology, Veterinary Biomedical Science or Veterinary Public Health.
Full time RegularColleague
Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
$50k-68k yearly est. Auto-Apply 60d+ ago
Clinical Coordinator: Behavioral Health Unit
Akron Children's Hospital 4.8
Clinical research coordinator job in Akron, OH
Behavioral Health Unit
Full Time 36 hours/week
Nights 7p-730a
every other weekend and holiday
Onsite
Assists manager in the daily operations at the unit level, in collaboration with interdisciplinary teams. Assesses, plans, implements, and evaluated delivery of patient care on assigned unit and shift. Contributes to development and evaluations of assigned nursing personnel. Assists and provides nursing care utilizing specialized knowledge, judgement and skill.
Responsibilities:
1. Provides leadership and direction regarding unit goals and work environment by assisting nurse manager in his/her duties.
2. Demonstrates personal and professional accountability for self and staff.
3. Maintains unit safety for staff and patients.
4. Participates in performance improvement.
5. Participates in and supports staff recruitment and retention efforts.
6. Uses critical thinking to provide patient care management through staffing plan development, managing daily shift staffing, and delegation of resources.
7. Supports and assists within human resource management, including but not limited to coaching, time keeping, development and evaluation of nursing personnel.
8. Supports patient care and staffing needs throughout the Akron Children's Hospital enterprise.
9. Promotes a positive work environment and staff engagement.
10. Serves as a clinical resource to the interdisciplinary team.
11. Demonstrates the knowledge and skills necessary to provide care for the physical, psychological, social, educational and safety needs of the patients served.
12. Other duties as required.
Other information:
Technical Expertise
1. Proficiency in MS Office [Outlook, Excel, Word] or similar software is required.
2. Valid Ohio license.
3. Current Health Care Provider BLS training from the American Heart Association is required.
4. See the Department of Nursing Resuscitation Requirements and training policy #2102 for specific department requirements.
5. Relevant professional nursing certification, preferred.
Education and Experience
1. Education: Graduate from an accredited School of Nursing, BSN required, or current enrollment in a BSN program with program completion required within 2 years of assuming position.
2. Certification: May differ based on department/unit
3. Years of experience: Minimum two years relevant clinical experience with demonstrated management and leadership abilities is required.
4. Years of experience supervising: Previous charge nurse or other leadership experience is required.
5. Strong leadership skills including communication/organizational skills, time management, coping skills, motivation, problem solving, autonomy, and supporting teams is required.
Full Time
FTE: 0.900000
Status: Onsite
$42k-53k yearly est. 6d ago
Oncology Clinical Research Coordinator
Actalent
Clinical research coordinator job in Detroit, MI
This role involves working directly with patients and conducting patient visits. The ClinicalResearchCoordinator will collaborate closely with research nurses and will have the support of Data and Regulatory teams. While a basic understanding of these functions is required, the Coordinator will not be responsible for them. The position involves working within teams divided by disease group, potentially including Phase 1 clinical trials.
Responsibilities
+ Conduct patient visits and work directly with patients.
+ Collaborate with research nurses as needed during patient visits.
+ Participate in recruitment activities using methods such as referrals, tumor board, and new consults.
+ Conduct chart reviews to support studies.
+ Support all studies within the team, without owning or leading any specific study.
+ Manage a patient load of no more than 10 patients a week, with patient visits varying by team and study phase.
Essential Skills
+ At least one year of clinical trial experience, including patient-facing roles, consenting patients, and conducting patient visits.
+ Experience in oncology or other complex therapeutic area.
+ Bachelor's Degree.
+ Experience with Phase 1 clinical trials.
Job Type & Location
This is a Contract to Hire position based out of Detroit, MI.
Pay and Benefits
The pay range for this position is $27.00 - $35.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in Detroit,MI.
Application Deadline
This position is anticipated to close on Jan 30, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
$27-35 hourly 3d ago
Research Nurse - Oncology First-in-Human Trials
Cleveland Clinic 4.7
Clinical research coordinator job in Cleveland, OH
Join the Cleveland Clinic Taussig Cancer Institute where more than 250 highly skilled healthcare professionals provide advanced cancer care to thousands of patients each year. This team focuses on a wide variety of services and innovations, including clinical trials and internationally-recognized research efforts. Here, you will work with the latest technologies, gain hands-on experience, receive endless support and build a rewarding career with one of the most respected healthcare organizations in the world.
As a Research Nurse for Oncology phase 1, you will support the implementation and conduct of human subject research projects, applying the nursing process while ensuring strict adherence to research protocol requirements. Responsibilities include timely completion and communication of regulatory documents, development of data capture and monitoring plans and reporting of serious adverse events. This position offers a unique opportunity to make a lasting impact by helping cancer patients access promising research treatments when standard options are limited, supporting them from their first interaction with the team through their return home.
A caregiver in this role works days from 8:00 a.m. - 4:30 p.m. or 8:30 a.m. - 5:00 p.m.
After six months, there may be an option to work from home one day per week depending on business needs.
A caregiver who excels in this role will:
Assist with coordinating the implementation and conduct of research projects ensuring adherence to research protocol requirements.
Complete and communicate regulatory documents, develop data, monitor plans, report Serious Adverse Events as the occur and complete FDA and sponsor forms.
Serve as a liaison between investigators, research personnel, outside study personnel and central research administration offices to assist in protocol interpretation, enrollment and safety questions.
Utilize the nursing process as a basis for patient care.
Assess research subjects, complete nursing assessments, document findings in research subject records and notify the physician of abnormal findings.
Establish a care plan in collaboration with the research subject, family and research team and coordinate ongoing care.
Identify discharge needs and facilitate discharge planning as appropriate.
Perform telephone triage, nursing procedures and treatments.
Evaluate, initiate and maintain standards of care consistent with CCHS policies & procedures.
Assist with specialized patient care equipment as required by the clinicalresearch protocol.
Administer medications and treatments as ordered by a physician or LIP.
Direct, coordinate and participate in the evaluation & supervision of nursing care provided to research subjects, establishing patient care priorities and delegating nursing activities according to the patient needs and staff qualifications and capabilities.
Conduct and document the informed consent process.
Successfully complete certification in Human Subjects Research within 90 days or hire as required by the Responsible Conduct of Research Guidelines adopted by Cleveland Clinic.
Minimum qualifications for the ideal future caregiver include:
Graduate from an accredited school of professional nursing
Current state licensure as a Registered Nurse (RN)
Basic Life Support (BLS) certification through the American Heart Association (AHA) or the American Red Cross
Two years of clinical experience
Within 90 days of hire, successfully complete certification in Human Subjects Research as required by the Responsible Conduct of Research guidelines adopted by Cleveland Clinic
Any registered nurse or advanced practice nurse must obtain a cancer specific certification or demonstrate ongoing qualifying education within the timeframe of the facilities accreditation cycle, if they work in medical oncology, radiation oncology, cancer center or cancer clinic and/or administer chemotherapy within an accredited Cleveland Clinic facility.
Basic computer proficiency
Preferred qualifications for the ideal future caregiver include:
Bachelor of Science in Nursing (BSN)
Oncology and/or research experience
Med-surg or ICU background
Physical Requirements:
Requires full range of body motion, manual and finger dexterity, and eye-hand coordination.
Requires standing and walking for extended periods of time.
Requires corrected vision and hearing to normal range.
Requires working under stressful conditions and irregular hours.
Exposure to communicable diseases and/or body fluids.
Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. Physical Demand requirements are in excess of those for Light Work.
Personal Protective Equipment:
Follows standard precautions using personal protective equipment as required.
Pay Range
Minimum Annual Salary: $57,510.00
Maximum Annual Salary: $87,697.50
The pay range displayed on this job posting reflects the anticipated range for new hires. A successful candidate's actual compensation will be determined after taking factors into consideration such as the candidate's work history, experience, skill set and education. The pay range displayed does not include any applicable pay practices (e.g., shift differentials, overtime, etc.). The pay range does not include the value of Cleveland Clinic's benefits package (e.g., healthcare, dental and vision benefits, retirement savings account contributions, etc.).
$57.5k-87.7k yearly 6h ago
Director - Clinical Research Scientist
Eli Lilly and Company 4.6
Clinical research coordinator job in Indianapolis, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Summary:
The Development ClinicalResearch Scientist will contribute to the oversight of clinical development program(s) in support of overall clinical development strategy and vision and serve as liaison and resource to various physicians and clinical trial sites, drawing on strong medical and scientific knowledge/principles, understanding compliance and regulatory requirements as well as awareness across business operations, and emerging issues.
Roles and Responsibilities of the Position:
Core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. The ClinicalResearch Scientist will apply scientific and clinical training and expertise to described roles.
Primary responsibility will be supporting the build, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts and other program documents.
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Reporting of adverse events as mandated by corporate patient safety.
Engage in clinical development contributions to due diligence or other business development activity. Contributes, as required by program needs and in collaboration with research colleagues, to design and implement translational strategies.
Acts in parallel with the clinical lead to solicit opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. The CRS serves as a scientific resource for study teams, departments, and others as needed.
Responsible for understanding the regulatory requirements related to clinical studies and global drug development and accountable for aligning with those requirements. Become a clinical representative for key regulatory discussions.
Minimum Requirements:
An advanced health/medical/scientific degree (such as DVM, PharmD, PhD, or MSN with advanced clinical specialty).
1+ years Clinical Trials/Research experience in pharmaceutical industry, academia, research setting with a strong preference for experience within in Oncology and/or Hematology.
Additional Preferences:
Breast cancer disease area knowledge.
Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors.
Strong analytical mind and problem-solving skills, thoughtful detail, strong organizational skills, and ability to work independently within a team.
Proven track record to bring out the best in others on a cross-functional international team. Leading by influence.
Proven track record to interact externally and internally to support a global scientific and business strategy.
Strong documentation and leadership qualities, including proficiency with MS Word, EndNote, PowerPoint and Excel.
Show one's true mettle to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
Strong communication, both written and oral.
Ability to multi-task and shift priorities rapidly to meet target dates.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $259,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$151.5k-259.6k yearly Auto-Apply 6d ago
Learn more about clinical research coordinator jobs
How much does a clinical research coordinator earn in Battle Creek, MI?
The average clinical research coordinator in Battle Creek, MI earns between $35,000 and $75,000 annually. This compares to the national average clinical research coordinator range of $37,000 to $72,000.
Average clinical research coordinator salary in Battle Creek, MI