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Clinical Research Assistant
SQRL
Clinical trials associate job in Columbus, OH
Highlights
$40,000 - $45,000 salary + benefits!
Unique opportunity to break into the Clinical Research space!
Work with a company that truly cares about their employees and patients
Consistent schedule, no overnights or weekends, Early Fridays, flex holidays, and more!
**We can only consider local candidates at this time, no relocation candidates**
About Our Client
Our client is a long standing clinical research site in the Columbus, OH area that takes a truly unique patient-centric, service-oriented, approach to clinical research. Their reputation for excellence has been built across over 20 therapeutic areas, over 15 physicians, and hundreds completed trials! They are looking to expand their team with additional clinical research assistants; also providing the exciting opportunity to train and develop into CRCs over time!
Job Description
As a Clinical Research Assistant, you will play a crucial role in supporting clinical research activities. Your will work closely with study team members under the direct supervision of a research manager and support other study team members to achieve study objectives and company goals! Compassion, patient focused mindset, and collaboration are all important traits!
Develop strong working relationships with team members and office staff to build a foundation of trust and respect
Assist with the screening, recruiting and enrollment of research patients
Perform patient scheduling
Collect patient history
Data entry and Management
Coordinate follow-up care and laboratory procedures
Adhere to an IRB approved protocol
Assist in the informed consent process of research subjects
Support the safety of research subjects
Coordinate protocol related research procedures study visits, and follow-up care
Schedule subject visits and procedures.
Work with various clinical research software
Qualifications Requirements:
1+ year experience in communication skills from a medical, patient facing setting
Ability to work on site Monday - Friday in Columbus, OH
Ability to or Willingness to learn blood draws, scans, EKG, vitals, etc
Highly professional in demeanor and presentation
$40k-45k yearly 2d ago
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Clinical Trial Associate (One-Year Contract)
Crispr Therapeutics 4.6
Remote clinical trials associate job
Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.
Position Summary
Working closely with the Sr. ClinicalTrial Manager and Clinical Operations Team, the ClinicalTrialAssociate (CTA) contract position will assist with daily clinicaltrial execution activities including the coordination of documents associated with the conduct of investigational clinical studies in accordance with applicable regulations, Good Clinical Practice (GCP), and CRISPR Therapeutics standard operating procedures (SOPs). The CTA will support the Sr. Director of Clinical Operations and ClinicalTrial Managers (CTM) in day-to-day activities for managing clinicaltrial conduct. The ideal candidate will have keen attention to detail and has the ability both to prioritize and handle multiple tasks effectively in a rapidly growing company environment.
This incredible opportunity will put the right candidate at the forefront of medicine, working on ground breaking trials with tremendous potential to impact patient's lives. You will join a team of incredibly dedicated professionals whose talent is matched by their commitment and passion for the work we are doing. A team that remains focused on what's important for the patient and also has an incredible track record of growth and development among them. If you are looking to learn, work hard, and make a difference, we would like to speak with you.
Responsibilities
Help maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out
Coordinate study documents and training tools for coordination with clinical sites
Collect trial information and disseminate it to the internal project team, the CRO, and other stakeholders
Coordinate study meetings, materials and agendas; record and disseminate decisions and actions
Responsible for internal meeting agendas/minutes as applicable
Responsible for updating, maintaining and quality control of the eTMF and other document repositories
Responsible for study laboratory sample tracking and vendor management support
Track new vendors and purchase orders in financial system
Coordinate version control of clinical documents, prioritize multiple tasks and/or projects
Assist in coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation Packages
Support Clinical Operations team with specific projects
Effectively communicate with study team members and work closely to address challenges
Minimum Qualifications
BS/BA degree or equivalent and at least 1-3 years experience in clinical operations in Sponsor company
Knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out procedures
Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations
Experience with eTMF; ability to directly apply essential document knowledge to file documents
Effective communication, organizational and interpersonal/team skills
Proficient in MS Excel, Word and PowerPoint. Knowledge of MS project and SharePoint preferred.
Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines
Participate in inter-departmental workgroups to create or enhance processes
Strong attention to quality/detail
Good organizational and time management skills
Willingness to work in a flexible environment
Preferred Qualifications
Additional Years of clinical operations experience inside a Sponsor company
Experience with global studies, using an outsourced CRO model
Experience in clinical drug development with knowledge of First in Human trials
Experience with regulatory affairs, including IND/CTA submissions
Knowledge of transplant, oncology or cellular therapies
Competencies
Collaborative - Openness, One Team
Undaunted - Fearless, Can-do attitude
Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems.
Entrepreneurial Spirit - Proactive. Ownership mindset.
CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.
Base pay range of $40.00 - $50.00 per hour.
The hourly rate provided is the reasonable estimate for this contract position. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
To view our Privacy Statement, please click the following link: ***********************************************
$40-50 hourly Auto-Apply 5d ago
Clinical Trial Associate
Avalyn Pharma
Remote clinical trials associate job
Avalyn is a biopharmaceutical company developing inhaled therapies for the treatment of rare respiratory diseases including pulmonary fibrosis and other interstitial lung diseases (ILD). Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn is developing a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn's lead program, AP01, is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b Study in progressive pulmonary fibrosis (PPF). Avalyn has initiated a Phase 2 study for its second program, AP02, inhaled nintedanib, that is being developed for the treatment of idiopathic pulmonary fibrosis (IPF). For more information, please visit avalynpharma.com and follow us on LinkedIn.
Position Overview:
The ClinicalTrial Assistant will provide general administrative and project support for clinical research studies. He/she will provide day-to-day operational support to the Clinical Operations and Study Management teams across Avalyn's clinicaltrials spanning PH 1-2b and beyond. This role will support study start-up, ongoing study conduct, and close-out activities in close collaboration with CRO partners, external vendors, and internal cross-functional teams. The ClinicalTrial Assistant will help coordinate global clinicaltrial activities by tracking key study milestones, deliverables, and timelines across investigational sites, and will assist in the preparation and organization of study materials for Investigator Meetings, Site Initiation Visits (SIVs), and other study-related meetings and communications.
Responsibilities:
· Support TMF related activities (sending / tracking Avalyn vendor documents to CRO TMF, TMF QC and reconciliation (through life of the trial and final reconciliation) Including conducting TMF audits based on the timing outlined in the applicable study plans
communicating issues identified to the CRO and tracking resolution of the identified issues.
· Create and maintain a SharePoint study file organization structure; build a file folder format consistent with TMF reference model to use consistently across all trials.
· Assist with study start-up, maintenance, and close-out activities in collaboration with CROs, vendors, and internal cross-functional teams.
· Responsible for coordination of meetings and generate meeting minutes
· Will assist in building Smartsheet or similar workspaces to house various study specific trackers allowing for a central location
· Responsible for supporting Data Review, identifying gaps/missing data, outliers, etc) to ensure accuracy of data. Track and report status of issues to resolution, escalating when appropriate.
· Support GCP compliance and inspection readiness activities by ensuring study documentation is complete, accurate, and well organized.
· Assist with internal audits, inspection preparation activities, and responses to audit findings as needed.
Required Qualifications:
· Minimum of Bachelor's degree in Life Sciences, Health Sciences, Nursing, Public Health, or a related field (or equivalent relevant experience)
· 2+ years of experience in Clinical Operations, Clinical Research, or a related clinicaltrial support role (industry or CRO)
· Working knowledge of clinicaltrial documentation and Trial Master File (TMF) requirements including the CDISC TMF reference model
· Experience supporting TMF activities, including document collection, filing, tracking, and basic QC
· Familiarity with electronic TMF (eTMF) systems and document management best practices
· Experience with TMF related activities (sending / tracking Avalyn vendor documents to CRO TMF, TMF QC (set a frequency through life of the trial and final recon)
· Ability to build, maintain, and update study trackers (e.g., Excel, Smartsheet, or similar tools)
· Strong attention to detail with the ability to identify missing, inconsistent, or incomplete information
· Excellent organizational, time management, and prioritization skills
· Strong written and verbal communication skills, including the ability to document meeting minutes clearly and concisely
· Ability to work collaboratively, as well as independently. with cross-functional teams, CROs, and external vendors
· Must be familiar with ICH GCP and appropriate regulations
· Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook)
Proposed pay range$90,000-$125,000 USD
$90k-125k yearly Auto-Apply 13d ago
Sr. Clinical Trial Associate
Allen Spolden
Remote clinical trials associate job
The remote -based ClinicalTrialAssociate (CTA) will perform tasks related to supporting operational strategy and and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.
Provide support for essential daily clinical study activities, including regulatory inspection readiness, following established protocols under the general management of the CTA Manager.
Work with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinicaltrial operating model.
Perform departmental tasks.
Perform developmental tasks with oversight of CTA Manager.
ACCOUNTABILITIES:
For assigned complex, accelerated, and business essential studies, provide support to focus on study startup and site initiation activities, including:
Approval of study documentation, including essential document packets, study plans, informed consent forms, etc.
Support oversight of risk -based monitoring.
Attend important team meetings.
Support regulatory inspection readiness (e.g. preparation of materials and participation during regulatory inspections.)
Support additional ad -hoc activities, as agreed with CTA Manager.
Work with internal departments (Legal, Insurance, R&D functions), CROs, and vendors.
Escalate clinicaltrial insurance issues.
Support Health Care Provider Engagement for facilitating contracts and meetings.
Support vendor contract administration.
Requirements
Bachelor's degree or equivalent international degree.
5 or more years' experience in pharmaceutical industry, clinical research organization, or related role.
Experience in Phase 2 and 3 studies and global/international studies is advantageous.
Experience working across multiple therapeutic areas is advantageous.
Knowledge in global regulatory and compliance requirements for clinical research.
Excellence in task management and collaboration.
Requires availability for 5 -10% domestic and international travel, including overnight and international travel on an as -needed basis.
Benefits
401(k) with company match and Annual Retirement Contribution Plan
Tuition reimbursement Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs
$73k-122k yearly est. 60d+ ago
Clinical Trials Associate
Immunitybio
Remote clinical trials associate job
ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease.
Why ImmunityBio?
• ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
• Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
• Work with a collaborative team with the ability to work across different areas of the company.
• Ability to join a growing company with professional development opportunities.
Position Summary
Responsible for clinicaltrials administration to ensure the most effective and efficient conduct of clinical research studies.
Essential Functions
Support the Clinical Operations teams in the completion of all required tasks to meet trial, departmental and project goals.
Maintain, share and champion a thorough knowledge ICH GCP, appropriate regulations, relevant SOPs and internal tracking systems.
Collaborate with ClinicalTrials Manager (CTM) and Clinical Research Associates (CRAs) to resolve clinicaltrial documentation issues.
Establish, organize and maintain clinical study documentation (e.g. Trial Master File, study level and site level documents, etc.) including preparation for internal/external audits, final reconciliation and archival.
Review clinicaltrial documents to determine compliance with Good Documentation Practices (GDocP), file and track study documents.
Determine materials and other resources needed to conduct the clinicaltrial and manage their acquisition and distribution.
Audit Investigator/Site invoices for accuracy, and reconcile invoices against the case report forms (CRFs) and budget for payment submission.
Gather central IRB report information, submit the report to the central IRB portal and track the IRB submissions from beginning through approval.
Facilitate the collection and review of required study documents during site start-up
Contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.)
Route study documents to the appropriate personnel for validated digital signatures
Submit purchase requisitions to Enterprise Resource Planning (ERP) System for Clinical Operations functional groups as needed. Request invoice approval from internal supplier designee.
Participate in clinical operations safety reporting activities; distribute, file and track safety reports and IRB submissions.
Facilitate clinical operations team meeting coordination, agenda preparation and meeting minutes preparation
Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.
Education & Experience
Bachelor's degree with 0-2 years of clinical research experience required; or
High school diploma with 5+ years of clinical research experience required
Knowledge, Skills, & Abilities
Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe
Excellent written/oral communication skills as well as strong organizational and multi-tasking skills
Maintain corporate confidentiality at all times.
Strong oral and written communication skills
Detail oriented, with solid organization and time management skills
Working knowledge of good documentation practices (GDP)
Working Environment / Physical Environment
This position works on site in El Segundo, CA or remotely depending on the candidate's geographic location
Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval.
This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.
National Market (all markets unless identified as Premium)
$70,000 (entry-level qualifications) to $77,000 (highly experienced) annually
Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston)
$73,800 (entry-level qualifications) to $81,000 (highly experienced) annually
The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
$70k-81k yearly Auto-Apply 2d ago
Clinical Trial Associate
Pathai 4.3
Remote clinical trials associate job
Who We Are
PathAI is on a mission to improve patient outcomes with AI-powered pathology. We are transforming traditional pathology methods into powerful, new technologies. These innovations in pathology can help accelerate drug development, improve confidence in the accuracy of diagnosis, and get life-saving therapies to patients more quickly. At PathAI, you'll work with a diverse and talented team of people, who are dedicated to solving complex problems and making a huge impact.
Over the past five years, PathAI has developed partnerships with many of the top global biopharmaceutical companies and biotechs, with the goal of integrating digital & computational pathology into the drug development process from early R&D through to commercial. As drug development increasingly trends towards personalized and targeted indications, computational pathology offers opportunities to enable faster and cheaper drug development, bringing lifesaving treatments to patients. To meet the constantly growing demand from our life sciences partners, PathAI is building out the Biopharma Partnerships team.
Where You Fit
The ClinicalTrialAssociate (CTA), Clinical Development Services will play a vital role in the Clinical Operations team. Through responsibilities like monitoring of clinicaltrial lab services, engaging with clinical investigator sites and supporting the primary CTM, this role will ensure successful completion of clinical studies with a lab services component.
What You'll Do
Study and Activity Monitoring:
Bring a strong understanding of GCP, ICH, and knowledge of regulatory requirements in support of successful clinicaltrials.
Adhere to the Code of Federal Regulations (Title 21) and guidelines set up by the International Committee for Harmonization (ICH) for good clinical practices.
Oversee and manage the timely closure of queries issued to clinicaltrial investigator sites and/or other designated parties.
Work with the CTM to proactively identify trends and provide feedback to internal departments and/or clients on performance of both the Investigator and the PathAI BioPharma Laboratory to ensure timely service delivery. Examples may include:
Monitor the performance of both the Investigator(s) and/or the Laboratory as applicable
Monitor study specific and/or Sponsor requested requirements.
Oversee and/or monitor queries, pending results, testing TATs, etc.
Collaborate with data management to ensure resolution of data discrepancies at all stages of the study.
Assist with the organization and tracking of storage specimens: receipt, retrieval, and shipping as applicable.
Coordinate with external vendors and Sponsors to ensure delivery of laboratory kits and test results to sites.
Provide Support to CTM:
Perform generic, routine study duties and tasks that are applicable across assigned clinicaltrials, including but not limited to: receipt of site lists, drafting of site facing laboratory manuals, managing laboratory kits orders, and monitoring the day-to-day trial operations (i.e., specimen management reports, case assignments on the PathAI AISight CT Platform, monitoring pending lab analysis, etc.).
Support the CTM for routine administrative tasks of the clinicaltrial (e.g., action item tracking, meeting minutes, process mapping, etc.).
Act as a backup support for the CTM during their times of absence, including leading client communication and study management activities.
Proactive lines of communication:
Interact with other functional areas and/or vendors to resolve problems, enhance processes, and service delivery.
Liaise with other departments and support services (e.g., Laboratory, Engineering, etc) to expedite testing of patient's laboratory specimens and/or provision of kits.
Coordinate information and communications for designated projects at the site level, including identification and escalation of discrepancies as needed.
Assist with the development of meeting or training materials where applicable.
Project Documentation and Deliverables:
Assist in reviewing study start up project deliverable schedule, milestones and required tasks
Support maintenance of project documentation files.
Oversee and/or lead Project Close-out procedures as required.
Assist with the development of meeting or training materials where applicable
Perform other administrative or process-related duties as needed to support the success of the trial.
What You Bring
3+ years of clinical research experience in medical device and/or drug development clinicaltrials and a BS or BA in a relevant scientific discipline.
Experience in digital pathology, radiology or other imaging technology-based clinicaltrials is highly preferred.
Good organizational skills, attention to details, and ability to multitask.
Project Management Certification is a plus.
We Want To Hear From You
At PathAI, we are looking for individuals who are team players, are willing to do the work no matter how big or small it may be, and who are passionate about everything they do. If this sounds like you, even if you may not match the job description to a tee, we encourage you to apply. You could be exactly what we're looking for.
PathAI is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications - that's all. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don't tolerate any kind of discrimination or bias, and we are looking for teammates who feel the same way.
The cash compensation outlined below includes base salary or hourly wage and on-target commission for employees in eligible roles. The summary below indicates if an employee in this position is eligible for annual bonus, overtime pay and equity awards. Individual compensation packages are tailored based on skills, experience, qualifications, and other job-related factors.
Annual Pay Range: $54,000 - $85,000
Not Overtime Eligible
Eligible for Equity
#LI-Remote
$54k-85k yearly Auto-Apply 10d ago
Clinical Trial Contracts Associate I
Stratacuity
Remote clinical trials associate job
ClinicalTrials Contracts Associate I (Remote) Rate: $25-$30/hour | Fully Remote We are seeking a ClinicalTrials Contracts Associate I to join our team and support the contracting process for clinicaltrials. This role is fully remote and involves both frontline and backend administrative duties to ensure smooth and compliant contract operations.
Key Responsibilities
* Contract Administration: Review, process, and maintain clinicaltrial contracts and related documentation.
* Collaboration: Work closely with clinical research teams, sponsors, and site staff to facilitate negotiations.
* Communication: Serve as a point of contact for stakeholders, providing updates on contract status.
* Process Improvement: Identify opportunities to streamline workflows and enhance efficiency.
* Contract Reconciliation: Research discrepancies, track pending agreements, and support execution steps.
Qualifications
* Education: Bachelor's degree in business, healthcare, or life sciences.
* Experience: 1-3 years in contract administration, clinicaltrials, or related field preferred.
* Skills: Strong attention to detail, organizational ability, and excellent verbal/written communication.
* Problem-Solving: Ability to identify issues and propose solutions in a fast-paced environment.
Why Join Us
This role offers the opportunity to contribute to the success of clinical research initiatives while working remotely. You'll play a vital part in ensuring contractual obligations are met and supporting teams that advance healthcare innovation.
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click here for more details.
Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.
Employee Type:
Contract
Remote:
Yes
Location:
Memphis, TN, US
Job Type:
Scientific and Clinical
Date Posted:
December 11, 2025
Pay Range:
$25 - $30 per hour
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$25-30 hourly 18d ago
Clinical Study Lead
Actalent
Remote clinical trials associate job
Job Title: Clinical Study LeadJob Description This role will be responsible for the regional operational execution, oversight, and management of one or more clinicaltrials from start-up through close out for Our Client's early-stage clinical programs. As a Regional Lead, you will work directly with cross-functional representatives including Medical Monitor, Clinical Science, Clinical Data Management, Regulatory, Biostatistics, Pharmacology, and Translational Science to ensure the successful completion of all clinical activities and project deliverables. You will apply your technical skills and play a key role in clinicaltrial planning and execution, helping to grow Our Client's pipeline.
Responsibilities
+ Support the Study Lead and Study Execution Team (SET) to ensure trials are initiated efficiently and completed on time, within budget, and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
+ Collaborate with SET to develop, review, and facilitate RFPs, and contribute to bid defense meetings for selecting CROs and other clinical vendors.
+ Manage various clinical vendors to achieve project and corporate goals on time.
+ Actively manage and resolve site issues in collaboration with Our Client's functional lines and CRO partners.
+ Contribute to the development and review of key clinical documents such as protocols and informed consent forms.
+ Serve as a subject matter expert on various company/department initiatives and participate in SOP and process development.
+ Oversee and manage vendor contracts, forecast financials, reconcile invoices, and ensure accuracy of CRO/vendor work orders.
+ Participate in the implementation and oversight of clinical systems including CTMS, TMF, EDC, and IRT.
+ Conduct clinical data reviews, generate queries, and participate in study activities such as site selection and start-up.
+ Provide input and support in the development and review of key study documents and track study metrics.
+ Proactively identify potential study risks, recommend mitigation strategies, and facilitate discussions for implementation.
+ Train investigators, site staff, vendors, and team members on study protocols and trial conduct processes.
+ Ensure the Trial Master File is set up and maintained, and participate in Quality Assurance and regulatory audits.
+ Perform other duties as assigned.
Essential Skills
+ Bachelor's degree in life sciences or a related discipline with 6+ years of experience in clinical and drug development.
+ Advanced knowledge of domestic and global clinical study management and vendor management experience in oncology.
+ Experience with early phase oncology trial management, including precision medicine trials.
+ Self-motivated with a focus on continuous improvement and innovative thinking.
+ Results-oriented team player with strong collaboration and relationship-building skills.
+ Detail-oriented and creative thinker with a passion for process optimization.
+ Excellent organizational, analytical, and communication skills in a fast-paced environment.
+ Ability to analyze and prioritize problems and propose solutions.
+ Willingness to travel as required (up to 40%).
Additional Skills & Qualifications
+ Experience in site management and early phase oncology trial management preferred.
+ Advanced knowledge of FDA and ICH/GCP regulations and guidelines.
Work Environment
Must work West Coast hours. The position can be fully remote.
Job Type & Location
This is a Contract position based out of Remote, OR.
Pay and Benefits
The pay range for this position is $65.00 - $88.00/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 fully remote position.
Application Deadline
This position is anticipated to close on Jan 23, 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.
$65-88 hourly 5d ago
Clinical Study Manager, FSP - IVD Experience Required
Invitrogen Holdings
Remote clinical trials associate job
REMOTE:
We welcome applicants from all locations within the US.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinicaltrials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinicaltrial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
We have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
Summarized Purpose:
Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on complex issues and makes good business decisions with support from line management. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically works independently on projects of moderate to high complexity, and may assume regional lead or Clinical Study Manager responsibilities.
Essential Functions
Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities.
Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required.
Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitors clinicaltrials to assess performance and ensure contractual obligations are met. May routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
Communicates with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
May coordinate all start-up activities, and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) are addressed. Reviews and follows up on all questions raised by ethics committees. Responsibilities may vary based on project timelines.
Provides input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.
In North America, where assigned to GPHS (Government & Public Health Studies) projects, may have limited line management responsibilities.
Job Complexity: Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
Job Knowledge: Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Some barriers to entry exist at this level (e.g., dept. / peer review). Level at which career may plateau.
Supervision Received
Determines methods and procedures on new assignments and may coordinate activities of other personnel (i.e., Team Lead). Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
Business Relationships: Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling of specific phases of projects or contracts. Creates formal networks with key contacts outside own area of expertise.
Qualifications:
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
Strong In Vitro Diagnostic Devices Regulations (IVDR), and ISO20916
Strong planning and organizational skills to enable effective prioritization of workload and workload of team members
Strong interpersonal and problem solving skills to enable working in a multicultural matrix organization
Solid understanding of change management principles
Comprehensive understanding of the practices, processes, and requirements of clinical monitoring
Strong judgment, decision making, escalation, and risk management skills
Effective oral and written communication skills, including English language proficiency
Capable of evaluating own and team members workload against project budget and adjust resources accordingly
Strong financial acumen and knowledge of budgeting, forecasting and fiscal management
Strong attention to detail
In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
Capable of independently managing clinical only studies
Management Role:
No management responsibility
Working Conditions and Environment:
· Work is performed in an office environment with exposure to electrical office equipment.
· Occasional drives to site locations with occasional travel both domestic and international.
Physical Requirements:
· Frequently stationary for 6-8 hours per day.
· Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
· Frequent mobility required.
· Occasional crouching, stooping, bending and twisting of upper body and neck.
· Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
· Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
· Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
· Frequently interacts with others to obtain or relate information to diverse groups.
· Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
· Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
· Regular and consistent attendance.
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
$61k-99k yearly est. Auto-Apply 3d ago
Clinical Study Manager-Remote(Job Id- 3908-1)
Artech Information System 4.8
Remote clinical trials associate job
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
• The Study Specialist will augment activities performed by existing study team members whether from client or client's preferred CROs by providing support to CRA activities to ensure adherence to study timelines and deliverables.
• This position will provide site level problem solving expertise for complex rare disease clinical studies in early and late phase development.
• Position will support all site management activities, which may include operational activities related to site evaluation, initiation, monitoring and close out for assigned clinical study sites to ensure compliance with ICH/Good Clinical Practices (GCP), client SOPs, protocol and patient safety.
Organizational Relationships:
• Oversight by client Clinical Operations Study Team Lead
• Role will lease with client Compliance Oversight Lead for monitoring related activities if they occur
• Interfaces with cross-functional study team members in a matrix environment (e.g., CRO Project Lead)
Primary Duties:
• Removing site obstacles to site start-up, maintenance and close-out while maintaining awareness of site dynamics with ability to motivate and educate site staff
• Exhibits ability to independently and proactively identify and interpret problems, recommend creative solutions, drive resolution, and influence appropriate changes
• Liaise with site, sponsor and CRO to provide site issue identification and resolution bringing sites to initiation, readiness to enroll and recruitment for assigned clinical research sites
• Point of escalation for clinically identified site related issues
• Problem solves identified issues (monitoring and/or regulatory) with appropriate escalation to Project Manager and/or designee
• Supports the management of multiple academic sites (e.g., clinical research naive requiring in depth coordination and support)
• Assures protection of the rights, safety, and wellbeing of subjects, study integrity and data quality
• Supports inspection readiness including for example the facilitation of the collection and maintenance of regulatory and site documentation for the Trial Master File and site file
• Supports local IRB workflow, submission through approval and reporting of safety information and may prepare answers, as required, to the IRB in conjunction with study team/Client
• Completes assigned training as necessary, including general training requirements, SOPs, system and process related training, and protocol specific training.
• Complies with all departmental objectives and metrics related to study execution
• Attend/lead/facilitate meetings as requested (i.e. investigator, project) to gain and/or share project/site knowledge
Secondary Duties
• As needed, performs site development and training (supporting and coaching site personnel), site monitoring, and site close-out activities for assigned clinical research sites with designated project SOPs, Client expectations, study specific protocol and GCPs
• As needed, supports activities such as but not limited to source data verification, case report form review, AE/SAE review and reconciliation, IP accountability, questionnaire reconciliation, equipment maintenance, supplies tracking and query resolution
• Complies with the Clinical Monitoring Plan (CMP) and becomes knowledgeable of the protocol to guide assigned sites in the proper conduct of the study
• Potential to complete monitoring reports in compliance with requirements in the Clinical Monitoring Plan
Training and Education Preferred:
• Bachelor's Degree in Life Science, RN preferred
• Minimum 5 years of study management experience with preferred focus in Rare Diseases (for example Sickle Cell Disease and/or other genetic hematological diseases) and experience in on-site monitoring
• Expertise in study start up and site management (experience in complex hospital-based Phase 3 clinicaltrials highly desirable)
• Demonstrated ability to problem solve and to prioritize site related activities
• Demonstrates solid understanding of drug development and clinical practices
• Understands and is able to comprehend study protocols
• Has knowledge of FDA regulations
• Possesses working knowledge of GCPs and other regulations governing clinical research
• Demonstrates technical expertise in computer skills
• Demonstrates diligent and self-motivated approach to working in an independent environment
• Demonstrates effective oral and written communication skills
• Travel anticipated at 25% but could up to 50% at times.
Qualifications
BS/MS
Additional Information
For more information, please contact
Akriti Gupta
**************
Morristown, NJ 07960
$66k-97k yearly est. 14h ago
US Northeast, Clinical Research Associate, Remote
Icon Plc 4.8
Remote clinical trials associate job
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Clinical Research Associate II/ Sr. Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinicaltrials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. CRA's must have Oncology experience, GVHD would be nice but not required. They should be willing to do dermatology if requested.
What you will be doing
* Conducting site qualification, initiation, monitoring, and close-out visits for clinicaltrials.
* Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
* Collaborating with investigators and site staff to facilitate smooth study conduct.
* Performing data review and resolution of queries to maintain high-quality clinical data.
* Contributing to the preparation and review of study documentation, including protocols and clinical study reports
Your profile
* Bachelor's degree in a scientific or healthcare-related field.
* Minimum of 2 years of experience as a Clinical Research Associate.
* In-depth knowledge of clinicaltrial processes, regulations, and ICH-GCP guidelines.
* Strong organizational and communication skills, with attention to detail.
* Ability to work independently and collaboratively in a fast-paced environment.
* Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
* Various annual leave entitlements
* A range of health insurance offerings to suit you and your family's needs.
* Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
* Global Employee Assistance Programme, 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.
Salary range: $110,520.00-$138,150.00
Bonus, Com, Stock, Benefits & Disclaimer verbiage:
Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance.
Are you a current ICON Employee? Please click here to apply
$110.5k-138.2k yearly 5d ago
Clinical Research Associate - Remote, US based
Getinge Group 4.5
Remote clinical trials associate job
With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
The Clinical Research Associate leads real-world research, market insights, and scientific communication initiatives supporting Healthmark's commercial and clinical strategy. This role designs and executes real-world studies on Healthmark products, analyzes data, monitors FDA safety alerts and outbreak reports, develops scientific publications, and supports presentations and educational content. The position blends research, evidence generation, and science communication to provide data-driven insights that shape product strategy, customer education, and marketplace understanding.
Job Responsibilities and Essential Duties:
* Design, plan, and conduct real-world studies evaluating Healthmark and Getinge products and other medical devices.
* Coordinate market research initiatives to identify customer needs, device performance trends, and marketplace gaps.
* Lead data collection, data analysis, and ensure adherence to study protocols.
* Perform routine surveillance of peer-reviewed literature, FDA MAUDE reports, outbreak summaries, and regulatory inspection findings.
* Synthesize findings into actionable reports, briefs, and recommendations for leadership and product teams.
* Write or co-author manuscripts, literature reviews, technical papers, white papers, and industry articles.
* Collaborate with the technical writer to prepare publications and educational content.
* Support conference presentations, webinars, and professional education materials with scientific research.
* Develop internal evidence briefs summarizing research trends and key literature updates.
* Partner with Marketing, Sales, Product Management, and R&D on evidence generation and product support.
* Represent Healthmark at scientific conferences and professional society meetings.
* Management of Key Opinion Leader (KOL) relationships.
* Work with R&D and Regulatory to conduct existing product research for regulatory submissions.
* Contribute to the creation of training materials, slide decks, and educational programs.
Required Knowledge, Skills and Abilities:
* Excellent data interpretation and scientific writing abilities.
* Strong project-management and organizational skills.
* Ability to translate complex scientific findings into clear, accessible communication.
* Proficiency with literature review tools, MAUDE database searches, and data analysis software.
* Strong presentation and public speaking skills.
* Ability to work independently and remotely.
Minimum Requirements:
* Master's degree in Public Health (MPH), Epidemiology, or related scientific discipline.
* 3-5 years of experience conducting real-world or post-market studies in healthcare or medical device settings.
* Experience with protocol development, data collection, analysis, and manuscript writing.
* Experience with peer-reviewed publication processes.
* Strong scientific communication skills, including writing and presenting.
* Experience in infection prevention, sterile processing, or medical device reprocessing strongly preferred.
* Ability to collaborate cross-functionally across clinical, marketing, regulatory, and product teams.
Environmental/Safety/Physical Work Conditions:
* 10% travel required.
* Sit when needed to do job.
* Stand for long periods of time.
* Wear PPE when required for the job.
* Be able to lift to 25 lbs.
The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The salary range for this job is a minimum of $80,000 to a maximum of $110,000 annually, plus 4% bonus potential.
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
* Health, Dental, and Vision insurance benefits
* 401k plan with company match
* Paid Time Off
* Wellness initiative & Health Assistance Resources
* Life Insurance
* Short and Long Term Disability Benefits
* Health and Dependent Care Flexible Spending Accounts
* Commuter Benefits
* Parental and Caregiver Leave
* Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
Nearest Major Market: Detroit
$80k-110k yearly 2d ago
Clinical Research, Clinical Research Associate (Remote)
Castle Biosciences 3.7
Remote clinical trials associate job
Castle Biosciences Earns "Top Workplaces USA Award" for Phoenix, Pittsburgh, and Friendswood! Learn more at ************************* Castle Biosciences Inc. is growing, and we are seeking to hire a full-time Clinical Research Associate to work remotely from a home-based office in the USA, preferably located in the greater Chicago area, St. Louis, Missouri, Ohio, Virginia, Pennsylvania, Nashville, Indianapolis, or Atlanta within close proximity to a major airport.
Why Castle Biosciences?
* Exceptional Benefits Package:
* Excellent Annual Salary + 20% Bonus Potential
* 20 Accrued PTO Days Annually
* 10 Paid Holidays
* 401K with 100% Company Match up to 6%
* 3 Health Care Plan Options + Company HSA Contribution
* Company Stock Grant Upon Hire
Salary Range: $90,000 - $95,000. Salary Range is based on Experience and Education levels.
A DAY IN THE LIFE OF A Clinical Research Associate
The Clinical Research Associate (CRA) is responsible for managing sites participating in Castle's clinical studies. Daily tasks vary based on study and site needs and may include attending team meetings, training site staff, sending emails, and traveling to U.S. sites to monitor data. The CRA performs all aspects of clinical monitoring and site management in compliance with ICH GCP, FDA guidelines, local regulations, protocols, and Castle's SOPs. This role ensures protocol and regulatory compliance, manages study documentation, and fosters strong relationships with sites. CRAs also play a key role in protecting participant safety, ensuring data quality, and representing Castle in the broader research community.
REQUIREMENTS
* Bachelor's degree in a science or healthcare-related field or a registered nursing certification, or equivalent certification/licensure from an appropriately accredited institution.
* 3 years of CRC experience or previous 1 year experience as a CRA.
* Direct patient care or clinical research experience required.
* Familiarity with clinical research and study development processes.
* Valid Driver's License where applicable.
* In some cases, a combination of education, professional training, and demonstrated experience that provides the required knowledge, skills and abilities may be considered.
TRAVEL/WORK ENVIRONMENT
* Regular overnight travel by car and air, typically 50-60% of the time, with potential peaks up to 80%
* Flexibility to accommodate an often changing and unpredictable timeline
* Frequent laptop use
* When in the office, there is a standard office environment with the use of a desk/phone/computer
* Generally, proof of COVID-19 vaccination will be required to access study sites, in accordance with site-specific guidelines and subject to any applicable exceptions as required by Federal, State, and Local laws.
SCHEDULE
* M-F travel-based position; working remotely from your home based in the USA near a major airport.
* Preferred locations include greater Chicago area, St. Louis MO, Ohio, Virginia, Pennsylvania, Nashville or Atlanta within close proximity to a major airport.
READY TO JOIN OUR BIOTECH TEAM?
We truly appreciate your time. If this feels like the right opportunity for you, we'd love for you to complete our mobile-friendly application. We're excited to learn more about you and look forward to connecting soon!
Castle Biosciences Awards and Research Developments!
WORK AUTHORIZATION
All candidates must be legally authorized to work in the United States. Currently, Castle Biosciences does not sponsor H-1B visas, OPT, or employment-related visas.
ABOUT CASTLE BIOSCIENCES INC.
At Castle, it all comes down to people. After all, disease doesn't just happen - it happens to people. We believe that disease management and treatment decisions can be better informed through a person's unique biology, which is revealed through the scientific rigor of our innovative, laboratory-developed tests. We are committed to empowering healthcare providers and patients with the goal of improved outcomes.
Every employee at Castle has an impact on patient care, and we work to ensure that everyone finds their work to be both challenging and rewarding. We behave with integrity and treat our colleagues with respect and kindness. Our culture fosters an environment of trust, transparency, and collaboration. We prioritize and encourage internal growth and professional development.
Castle Biosciences is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.
If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail ReasonableAccommodationsRequest@castlebiosciences.com.
This email was created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.
No third-party recruiters, please
$90k-95k yearly 8d ago
US, Central, Clinical Research Associate, Remote
Icon Clinical Research
Remote clinical trials associate job
US Central, Clinical Research Associate, Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinicaltrials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. CRA's must have Oncology experience, GVHD would be nice but not required. They should be willing to do dermatology if requested.
**What you will be doing**
+ Conducting site qualification, initiation, monitoring, and close-out visits for clinicaltrials.
+ Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
+ Collaborating with investigators and site staff to facilitate smooth study conduct.
+ Performing data review and resolution of queries to maintain high-quality clinical data.
+ Contributing to the preparation and review of study documentation, including protocols and clinical study reports
**Your profile**
+ Bachelor's degree in a scientific or healthcare-related field.
+ Minimum of 2 years of experience as a Clinical Research Associate.
+ In-depth knowledge of clinicaltrial processes, regulations, and ICH-GCP guidelines.
+ Strong organizational and communication skills, with attention to detail.
+ Ability to work independently and collaboratively in a fast-paced environment.
+ Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, 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
$54k-85k yearly est. 5d ago
Clinical Research Associate II
Glaukos Corporation 4.9
Remote clinical trials associate job
How will you make an impact?
Responsible for assessing the study capabilities of potential study sites, training, on-site monitoring, closure, and management of sites participating in clinical research studies sponsored by Glaukos. The Clinical Research Associate (CRA) is responsible for maintaining data integrity and monitoring study conduct in accordance with regulations and the study protocol at the site level.
What will you do?
CLINICAL SITE MONITORING
Travel to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits
Assist with selection of potential investigators
Conduct initial and ongoing site training throughout the course of the study
Verify informed consent process is properly followed
Evaluate investigator compliance with the study protocol and applicable regulations
Verify sites are collecting all required source data per protocol, accurately completing Case Report Forms, and resolving all data queries
Review the regulatory binder and essential documents at the site and verify all documents are appropriately filed
Verify and reconcile site's essential documents against the trial master file as required
Oversee and conduct monitoring activities, including remote monitoring when applicable
Verify investigational product is properly stored, dispensed, returned, and that accountability of the product and masking requirements are maintained throughout the study
CLINICAL SITE MANAGEMENT
Lead/manage assigned sites through regular contact with investigators and site staff to monitor progress, answer questions, and provide guidance during the course of the clinical study
Critically review and analyze site activities through frequent visits and contacts to monitor study sites and performance
Build relationships with the Investigators and site staff to enhance productivity, as well as collaborate with study management on protocol discrepancies, improving efficiency, and monitoring data integrity
Manage the progress of assigned studies by tracking subject enrollment, data collection, CRF completion, source data verification, data query generation and resolution, and investigational product accountability
Monitor subject safety and address protocol deviations, data quality issues, drug accountability, and identify process improvements for assigned sites.
Create and maintain appropriate documentation (e.g., visit reports/letters)
regarding site management, monitoring visit findings, and action plans
Ensure audit and inspection readiness of assigned sites
Advise on pre-audit activities for GCP requirements
Be familiar with assigned study timelines and communicate potential issues to study management
How will you get here?
Works independently with minimal supervision
Conducts all types of site visits
Build strong productive relationships with study investigators, site staff, and study management personnel
Participates in department projects 2 to 5 years work experience as a regional CRA; 5 years direct clinical research experience
Experience in the medical device and pharmaceutical industry is preferred, and ophthalmology experience is strongly preferred for all levels of a CRA
Knowledge and understanding of Good Clinical Practices (ICH E6 R2)
Knowledge and understanding of FDA's Code of Federal Regulations applicable to conducting clinical research studies
Must have proficient computer skills and experience with Microsoft Office
Must be willing and able to travel approximately 75-80%, including overnight, domestic and international
Must have Self-directed behavior
#GKOSUS
$53k-81k yearly est. Auto-Apply 11d ago
Clinical Research Associate II
Global 4.1
Remote clinical trials associate job
How will you make an impact?
Responsible for assessing the study capabilities of potential study sites, training, on-site monitoring, closure, and management of sites participating in clinical research studies sponsored by Glaukos. The Clinical Research Associate (CRA) is responsible for maintaining data integrity and monitoring study conduct in accordance with regulations and the study protocol at the site level.
What will you do?
CLINICAL SITE MONITORING
Travel to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits
Assist with selection of potential investigators
Conduct initial and ongoing site training throughout the course of the study
Verify informed consent process is properly followed
Evaluate investigator compliance with the study protocol and applicable regulations
Verify sites are collecting all required source data per protocol, accurately completing Case Report Forms, and resolving all data queries
Review the regulatory binder and essential documents at the site and verify all documents are appropriately filed
Verify and reconcile site's essential documents against the trial master file as required
Oversee and conduct monitoring activities, including remote monitoring when applicable
Verify investigational product is properly stored, dispensed, returned, and that accountability of the product and masking requirements are maintained throughout the study
CLINICAL SITE MANAGEMENT
Lead/manage assigned sites through regular contact with investigators and site staff to monitor progress, answer questions, and provide guidance during the course of the clinical study
Critically review and analyze site activities through frequent visits and contacts to monitor study sites and performance
Build relationships with the Investigators and site staff to enhance productivity, as well as collaborate with study management on protocol discrepancies, improving efficiency, and monitoring data integrity
Manage the progress of assigned studies by tracking subject enrollment, data collection, CRF completion, source data verification, data query generation and resolution, and investigational product accountability
Monitor subject safety and address protocol deviations, data quality issues, drug accountability, and identify process improvements for assigned sites.
Create and maintain appropriate documentation (e.g., visit reports/letters)
regarding site management, monitoring visit findings, and action plans
Ensure audit and inspection readiness of assigned sites
Advise on pre-audit activities for GCP requirements
Be familiar with assigned study timelines and communicate potential issues to study management
How will you get here?
Works independently with minimal supervision
Conducts all types of site visits
Build strong productive relationships with study investigators, site staff, and study management personnel
Participates in department projects 2 to 5 years work experience as a regional CRA; 5 years direct clinical research experience
Experience in the medical device and pharmaceutical industry is preferred, and ophthalmology experience is strongly preferred for all levels of a CRA
Knowledge and understanding of Good Clinical Practices (ICH E6 R2)
Knowledge and understanding of FDA's Code of Federal Regulations applicable to conducting clinical research studies
Must have proficient computer skills and experience with Microsoft Office
Must be willing and able to travel approximately 75-80%, including overnight, domestic and international
Must have Self-directed behavior
#GKOSUS
$50k-79k yearly est. Auto-Apply 11d ago
Clinical Research Associate (PhD Candidates)
Medpace 4.5
Remote clinical trials associate job
Join our CRA Team in Cincinnati, Ohio! The Clinical Research Associate position at Medpace offers the unique opportunity to have an exciting career in the research of drug and medical device development while making a difference in the lives of those around them. For those with PhD/Life Science backgrounds who want to explore the research field, travel the US, and be part of a team bringing pharmaceutical and medical devices to market - this could be the right opportunity for you!
MEDPACE CRA TRAINING PROGRAM (PACE )
No research experience is needed as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs. Through our PACE Training Program, you will join other Professionals Achieving CRA Excellence:
* PACE provides the platform to effectively and confidently carry out your duties, enhance your current abilities and ultimately help you become a high-functioning independent Medpace CRA.
* PACE will prepare you by developing your CRA skills through interactive discussions and hands on job-related exercises and practicums.
* To supplement your in-house and field-based training you may also participate in other clinical research departmental core rotations, learning other aspects of the drug/device development and approval process.
WHY BECOME A CRA
This role takes you on a journey through travel and excitement which will allow you to make a difference on a large scale through the enhancement of pharmaceuticals and medical devices. The CRA position provides many other distinctive advantages including:
* Dynamic working environment, with varying responsibilities day-to day
* Expansive experience in multiple therapeutic areas
* Work within a team of therapeutic and regulatory experts
* Defined CRA promotion and growth ladder with potential for mentoring and management advancements
* Competitive pay and many additional perks unmatched by other CROs (SEE BELOW).
WE OFFER THE FOLLOWING
* Competitive travel bonus;
* Equity/Stock Option program;
* Training completion and retention bonus;
* Annual merit increases;
* 401K matching;
* The opportunity to work from home;
* Flexible work hours across days within a week;
* Retain airline reward miles and hotel reward points;
* Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere;
* In-house travel agents, reimbursement for airline club, and TSA pre-check;
* Opportunity for leadership positions - Lead CRA, CRA Manager, ClinicalTrial Manager, Training and Development Manager, and many more;
* CRA training program (PACE );
* Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts;
* In-house administrative support for all levels of CRAs; and
* Opportunities to work with international team of CRAs.
Responsibilities
* Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
* Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
* Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
* Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
* On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated ClinicalTrial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;
* Verification that the investigator is enrolling only eligible subjects;
* Regulatory document review;
* Medical device and/or investigational product/drug accountability and inventory;
* Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
* Assess the clinical research site's patient recruitment and retention success and offering suggestions for improvement; and
* Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
Qualifications
* Must have a minimum of a Bachelor's degree in a health or life science related field;
* Ability to travel 60-70% to locations nationwide is required, or less if remote/virtual visits required;
* Must maintain a valid driver's license and the ability to drive to monitoring sites;
* Minimum 1 year healthcare-related work experience preferred;
* Proficient knowledge of Microsoft Office;
* Strong communication and presentation skills; and
* Must be detail-oriented and efficient in time management.
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-73k yearly est. Auto-Apply 8d ago
Clinical Trial Coordinator - Onsite Position - Columbus, Ohio
Orsini Healthcare 4.4
Clinical trials associate job in Columbus, OH
Careers with real impact.
Every role at Orsini moves a patient closer to life-changing therapy. We partner with biopharma innovators, healthcare providers, and payers to make access simple, compassionate, and reliable - so no patient is left behind. Make your next role matter.
ABOUT ORSINI
Providing compassionate care since 1987, Orsini is a leader in rare disease and gene therapy pharmacy solutions, built to simplify how patients connect to advanced medicines. Through our comprehensive commercialization solutions including a nationwide specialty pharmacy, patient services hub, home infusion and nursing network, and third-party logistics provider, we work with biopharma, providers, and payors to ensure No Patient is Left Behind™
OUR MISSION
Orsini is on a mission to be the essential partner for biopharma innovators, healthcare providers, and payers to support patients and their families in accessing revolutionary treatments for rare diseases. Through our integrated portfolio of services, we seek to pioneer comprehensive solutions that simplify how patients connect to advanced therapies while providing holistic, compassionate care so that No Patient is Left Behind™.
CORE VALUES
At the heart of our company culture, the Orsini LIVE IT Core Values serve as guiding principles that shape how we interact with each other and those we serve. These values are the driving force behind our commitment to excellence, collaboration, and genuine care in every aspect of our work.
COMPENSATION & LOCATION
The salary range for this role is $80,000-$90,000.
This on-site position based out of our Columbus, Ohio. Travel to other locations may occur, although minimal.
POSITION SUMMARY
The ClinicalTrial Coordinator will oversee and manage the dispensing operations for clinicaltrials and Early Access Programs for Orsini. This role ensures compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards while coordinating with sponsors, CROs, investigators, and internal pharmacy teams. The position is critical for maintaining accuracy, integrity, and timely delivery of investigational products to trial participants.
Essential Duties
Serve as the primary liaison between the specialty pharmacy, clinicaltrial sponsors, CROs, and clinical sites. Provide timely updates on IP status, shipment schedules, and dispensing activities.
Coordinate all pharmacy-related activities for assigned clinicaltrials, including investigational product (IP) receipt, storage, dispensing, and accountability. Ensure adherence to study protocols, sponsor requirements, confidentiality, and regulatory guidelines. Maintain accurate documentation for IP handling, including temperature logs, chain of custody, and dispensing records.
Ensure compliance with state and federal pharmacy laws, clinicaltrial regulations, and specialty pharmacy accreditation standards.
Prepare for and support audits and inspections by sponsors, CROs, and regulatory authorities.
Manage investigational product inventory, including reconciliation and returns in conjunction with the inventory management team.
Implement quality assurance processes to ensure accuracy and prevent protocol deviations.
Train pharmacy staff on study-specific requirements and handling procedures.
Maintain SOPs and ensure proper documentation for all trial-related activities
Disclaimer: The information written in this indicates the general nature and level of work to be performed. This is not designed to contain or be interpreted as totally comprehensive of every job duty, responsibility, or qualification required by an employee assigned to this job. While employed in this position, an employee may be required to perform other assignments not listed in this job description.
KNOWLEDGE, SKILLS, AND TRAINING
Pharmacy Technician License.
Bachelor's degree in Life Sciences, or related field.
Minimum 2-3 years of experience in clinicaltrials or investigational drug services.
Familiarity with GCP, FDA regulations, and clinicaltrial operations.
Strong organizational and project management skills.
Excellent communication and collaboration abilities.
Proficiency in clinicaltrial management systems and pharmacy dispensing software.
NICE TO HAVE'S
Certified Clinical Research Coordinator (CCRC) or equivalent.
Specialty Pharmacy experience.
EMPLOYEE BENEFITS
We offer a comprehensive benefits package designed to support your health, financial security, and overall well-being:
Medical Coverage, Dental, and Vision Coverage
401(k) with employer match
Accident and Critical Illness coverage
Company-paid life insurance options
Generous PTO, paid holidays, and floating holidays
Tuition reimbursement program.
Equal Employment Opportunity
Orsini Rare Disease Pharmacy Solutions is committed to the principle of Equal Employment Opportunity for all employees and applicants. It is our policy to ensure that both current and prospective employees are afforded equal employment opportunity without consideration of race, religious creed, color, national origin, nationality, ancestry, age, sex, marital status, sexual orientation, or present or past disability (unless the nature and extent of the disability precludes performance of the essential functions of the job with or without a reasonable accommodation) in accordance with local, state and federal laws.
Americans with Disabilities Act
Applicants as well as employees who are or become disabled must be able to perform the essential job functions either unaided or with reasonable accommodation. The organization shall determine reasonable accommodation on a case-by-case basis in accordance with applicable law.
$80k-90k yearly Auto-Apply 3d ago
Senior Clinical Trial Specialist - Remote Position
Puma Biotechnology, Inc. 4.3
Remote clinical trials associate job
The Senior ClinicalTrial Specialist (Sr. CTS) is responsible for providing operational support for the day-to-day execution of clinicaltrials, following established SOPs, GCP and applicable regulatory requirements in the execution of all activities; proactively identifying and resolving operational project issues; and participating in process improvement initiatives as required.
Major Duties/Responsibilities
* Ensures timely and accurate study-related communication to clinical personnel (eg, internal and external study teams, consultants and investigative site personnel); prepares and disseminates clinicaltrial correspondence, newsletters, and IND safety letters (working with project clinician); and assists with the creation of study-specific manuals, tools, and templates
* Participates in selection and management/oversight of external vendors and develops vendor specifications; reviews vendor reports, budgets, and metrics; acts as liaison between vendors and sites (eg, assists sites with laboratory sample queries)
* Coordinates specified clinicaltrial meetings (eg, investigator meetings, study team meetings, CRA and CRO meetings) by arranging logistics, preparing necessary materials and recording and distributing minutes
* Sets up, tracks, collects and maintains audit-ready clinicaltrial documentation and study status in an electronic system; manages and tracks regulatory/IRB/IEC documentation, IND safety letter distribution, confidentiality disclosure agreements, and other clinicaltrial documents; performs initial QC of electronic data feeds; generates, reviews and distributes reports; assists with quality assurance audits and resolution of audit findings
* Participates in study design and execution by contributing operational experience and expertise: provides input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications; assists with study or site feasibility process; posts and maintains study-related information on external websites when applicable
* Ensures that necessary study supplies are available as per study timelines: sources clinicaltrial supplies through external vendors (eg, case report forms, study manuals, lab kits); manages, reviews and tracks drug shipment, destruction, and return; coordinates internal lab sample supply set-up and shipment
* Maintains ongoing communication with site staff to resolve issues (eg, data queries, study management), support the staff, oversee the efficient conduct of the trial, and ensure continued compliance
* May also be responsible for acting as a central point of communication between Puma and investigative sites for all assigned clinicaltrial-related activities to assure trials are conducted on time and budget, while fully compliant with ICH GCP and the SOPs in effect. In this role, the Sr. CTS may be responsible for:
* Conducting on-site visits consistent with the applicable Clinical Monitoring Plan and SOPs for site qualification, site initiation, routine monitoring, site close-out and other site visits (eg, booster), as requested
* Overseeing site recruitment, implementing appropriate contingency plans, as needed
* Assessing site performance and conducting training/re-training when necessary to ensure site compliance with the protocol, applicable regulations and Puma expectations
* Writing confirmation letters, follow-up letters and site visit reports that conform with guidelines and timelines stated in the applicable Clinical Monitoring Plan and SOPs
* Mentors more junior staff
* Manages study team meetings in absence of ClinicalTrial Manager
* Performs other tasks, as assigned by the manager/designee to promote the efficient conduct of the trial
Skills & Abilities
* Clear and timely communication, both written and verbal
* Ability to handle a moderate volume of highly complex tasks within an established timeframe
* Strong organizational skills and ability to prioritize
* Ability to build relationships within the team, across departments, and with external contacts (eg, vendors, site staff)
* Proactively identify and resolve/escalate project-related operational issues
* Ability to work independently on routine assignments, and take over new assignments based on previous experience
* Familiarity with word processing, spreadsheet and document management systems
Travel
Travel required up to 25%.
Education & Professional Experience
Required:
* Bachelor's degree or equivalent combination of education/experience, preferably in science or a health-related field
* Strong understanding of GCP, ICH and knowledge of regulatory requirements
* Minimum one year prior ClinicalTrial Specialist experience or commensurate
Preferred:
* One year of clinical research experience or health-related experience (eg, study coordinator, data management, nursing)
* Completion of Puma Field Monitoring Course or equivalent, as required for field monitoring activities
* Oncology experience
* Global trial experience
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Physical Demands
The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply.
Compensation Range
The salary range for this role is $90,000 - $100,000 per year. Higher compensation may be available for someone with advanced skills and/or experience.
At Puma Biotechnology, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), an annual bonus target, and a robust benefits package. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
#LI-Remote
$90k-100k yearly 30d ago
Director - Clinical Research Scientist - Immunology/Gastroenterology Development
Eli Lilly and Company 4.6
Remote clinical trials associate job
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.
The GI Therapeutic Area within Lilly Immunology Development is focused on developing new therapies for patients with gastrointestinal diseases. The GI immunology development team is seeking a motivated clinical research scientist that is passionate about drug development within gastroenterology. The candidate must have extensive drug development experience in mid-to-late phase trials. They will engage in various trial related activities including but not limited to the development, conduct and reporting of global clinicaltrials in support of registration and commercialization of new therapies; the reporting of adverse events; the drafting and review process for protocols, study reports, publications; engagement with global regulatory authorities and other governmental agencies; outreach medical activities including thought leaders engagement.
Key Objectives/Deliverables
The primary responsibilities of the Development CRS are generally related to late-phase and marketed compounds. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned.
Clinical Planning: product lifecycle plan, clinical strategies, development plans and study protocol design. Provide subject matter expertise and keep updated with the pre-clinical and clinical data relevant to the molecule
ClinicalTrial Execution and Support: Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions. Supports the monitoring of patient safety during study and engages in the global product safety reviews. Cross function collaboration with clinicaltrial teams in the design, conduct and reporting of mid to late phase clinicaltrials. Conduct study start-up meetings, investigator meetings and other activities to provide the appropriate training and information to investigators and site personnel.
Scientific Data Dissemination/Exchange: engage in reporting of clinicaltrial data in ClinicalTrial Registry activities. Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Establish and maintain collaborations and relationships thought leaders. Support clinicaltrial data analysis and publications.
Regulatory Support Activities: Provide medical expertise to regulatory scientists and support regulatory strategy.
Scientific and Technical Expertise and continued development: Acts as scientific consultant and protocol expert for clinical study team members and others in medical.
Minimum Requirements
An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as, PharmD, PhD
3+ years of clinical development experience, including mid-to-late-stage development
Additional Skills/Preferences
Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills
Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills
Previous GI drug development experience
Pediatric drug development experience
Oral/written communication/listening skills are essential
Strong relationship-building and interaction skills with peers and management
Preferred location is Indianapolis, though remote arrangements may be considered
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 - $338,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly