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CT Clinical Study Manager
Philips Healthcare 4.7
Remote clinical research monitor job
Job TitleCT Clinical Study ManagerJob Description
Clinical Study Manager, Computed Tomography (EST Time zone)
The Clinical Study Manager will be responsible for the execution and regulatory compliance of clinical studies for our Computed Tomography business.
Your role:
Manages and executes clinical studies with strict adherence to protocols, regulatory standards (ISO, GCP, FDA), and Philips procedures, ensuring data accuracy, integrity, and effective handling of deviations.
Provides expert guidance and support to study sites and investigators on regulatory requirements, protocol adherence, and Good Clinical Practice, while reviewing study documentation for completeness and compliance.
Enhances and streamlines clinicalresearch processes through continuous data review, process optimization, and proactive resolution of queries and discrepancies related to study conduct and regulatory compliance.
Collaborates and communicates effectively with internal cross-functional teams and external partners, facilitating alignment, issue resolution, and achievement of project objectives throughout the study lifecycle.
Monitors study progress, milestones, and budgets, conducts trend analysis for risk mitigation, and delivers timely study updates and recommendations to leadership and senior management.
You're the right fit if:
You've acquired 3+ years of related experience in clinicalresearch execution in the medical device industry. Experience using EDC, CTMS, and eTMF systems is highly preferred.
Your skills include profound knowledge of clinicalresearch process legislation and ICH-GCP guidelines.
You have a Bachelor's/master's degree or higher in Life Sciences or an equivalent field.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
You demonstrated strong analytical, project management, and communication skills; thrive in cross-functional environments, and are committed to maintaining high standards of data integrity and regulatory compliance. Must be willing to travel up to 50% globally to study sites, based on business needs.
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.
This is a field-based role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.
Learn more about our culture.
Philips Transparency Details
The pay range for this position in AL, FL, GA, MI, NH, NC, OH, PA, VT, VA, WI is $101,250 to $162,000.
The pay range for this position in DE, MD, RI, is $106,313 to $170,100.
The pay range for this position in CT, MA, NJ, NY, DC, is $113,400 to $181,440.
The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
Additional Information
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
Company relocation benefits will not be provided for this position.
#LI-PH1
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
$113.4k-181.4k yearly Auto-Apply 15d ago
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Clinical Research Associate - Oncology
ZP Group 4.0
Remote clinical research monitor job
Piper Companies is seeking a well-rounded ClinicalResearch Associate with direct oncology monitoring experience to work with a Global CRO. The ClinicalResearch Associate will be working remote with some travel included. Requirements for the ClinicalResearch Associate include:
* Conducting site monitoring visits in line with GCP and ICH guidelines
* Ensure project needs are met by collaborating with local sites
* Oversee regulatory submissions, CRF completion, and data query resolutions
* Ensure documentation is properly formatted and filed; TMF and ISF
* Mentor clinical staff during visits
Qualifications for the ClinicalResearch Associate include:
* 2+ years of Oncology monitoring experience
* 2+ years of onsite monitoring experience
* Able to travel locally for work
* Proficient in GCP and ICH guidelines
* Understand Microsoft Office and mobiles devices
* Strong understanding of Phase 1 oncology trials (phase 2 and 3 are welcomed)
* Bachelor's degree in a related field
Compensation for the ClinicalResearch Associate includes:
* Salary range: $90,000 - $120,000
* Comprehensive benefit package: Medical, Dental, Vision, 401k match plus PTO, Sick leave as required by law, and Paid Holidays
Keywords: Clinicalresearch associate, CRA, hospital, travel, oncology, documentation, trials, trial sites, cancer, cancer research, GCP, ICH, recruitment plans, projects, project, protocol adherence, regulatory submissions, enrollment, CRF completion, data, data query, start-up phase, phase 1, trial master file, TMF, Investigators site file, ISF, mentorship, Microsoft office, mobile devices
#LI-BH1 #LI-REMOTE
This job opens for applications on 12/12/2025. Applications for this job will be accepted for at least 30 days from the posting date.
$90k-120k yearly 19d ago
In-House Clinical Research Associate (Biotech - REMOTE)
Actalent
Remote clinical research monitor job
We are seeking a skilled ClinicalResearch Associate to join our dynamic Clinical Development team. This role will support and manage various aspects of clinical trials, ensuring that studies are conducted efficiently and in compliance with regulatory standards.
Responsibilities
* Support the Trial Manager in tracking regulatory submissions and approvals, recruitment, and enrollment for assigned studies.
* Assist in site start-up activities, including oversight of CRO start-up activities, essential document package review, and participation in initiation visits.
* Collaborate with the contracts team to review and negotiate site and vendor budgets/contracts.
* Contribute to the development and review of study, patient, and site-facing documents such as protocols and informed consent forms.
* Ensure meeting agendas are clear and distributed in advance; take comprehensive minutes for internal and external meetings.
* Participate in CRO monitoring activities and co-monitoring visits to ensure compliance with protocol and regulatory requirements.
* Identify potential operational challenges and collaborate with senior team members to provide solutions.
* Adhere to Clinical Operations processes and SOPs to maintain studies in an 'inspection ready' state.
* Support the oversight of vendors, review site invoicing, and manage financial aspects in accordance with clinical trial agreements.
* Engage in TMF activities, including review of TMF index and document provision.
* Support onboarding and mentoring of new department members.
* Comply with workplace health and safety policies and procedures.
* Perform other duties as assigned by the supervisor.
Essential Skills
* Experience in vendor management and clinicalresearch.
* Proven monitoring oversight experience, including co-monitoring or remote monitoring.
* Experience with site contracts and budgets.
* Familiarity with TMF activities, such as review of TMF index and document provision.
Additional Skills & Qualifications
* At least 4+ years of relevant clinical operations experience.
* Bachelor's degree in Life Sciences with at least 2 years in a pharmaceutical sponsor environment.
* Excellent attention to detail and strong verbal, written, interpersonal, and presentation skills.
* Familiarity with routine medical/scientific terminology.
* Proficiency with MS Office.
* Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs is desirable.
* Ability to participate in strategic initiatives under general supervision.
* High energy, personal productivity, initiative, creativity, and commitment.
* Team-player attitude, eager to work in a fast-moving, dynamic start-up environment.
Work Environment
This role is primarily remote, requiring occasional travel (10-20%). The position is within a growing Clinical Development team based on the East Coast, with candidates ideally located in the Eastern Standard Time zone. The company offers an exciting opportunity to learn and take on additional responsibilities in a small but growing biotech environment.
Job Type & Location
This is a Permanent position based out of Gaithersburg, MD.
Pay and Benefits
The pay range for this position is $90000.00 - $115000.00/yr.
Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan
Workplace Type
This is a fully remote position.
Application Deadline
This position is anticipated to close on Dec 31, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
$90k-115k yearly 10d ago
Clinical Research Associate (West Coast)
Atrium Staffing
Remote clinical research monitor job
Our client is a respected global clinicalresearch partner, known for delivering high-quality trial support and regulatory compliance across a variety of therapeutic areas. This organization partners with major biopharmaceutical sponsors to ensure efficient and ethical clinicalresearch execution across the U.S. They are currently looking to add a ClinicalResearch Associate (West Coast) to their team.
Salary/Hourly Rate:
$100k - $120k, Based on experience, with travel reimbursement and potential performance incentives.
Position Overview:
An exciting opportunity has opened for a ClinicalResearch Associate (West Coast) with extensive site monitoring experience to join a growing team focused on West Coast clinical trials. The ClinicalResearch Associate (West Coast) will be the key contact for assigned investigative sites, ensuring protocol adherence, subject safety, and quality data collection throughout the trial lifecycle. This remote-based position is ideal for a motivated and experienced ClinicalResearch Associate (West Coast) who is comfortable traveling to various regional sites while managing multiple aspects of site performance.
Responsibilities of the ClinicalResearch Associate (West Coast):
* Perform all required monitoring visits (SQV, SIV, IMV, COV) in alignment with protocol and regulatory standards.
* Serve as the primary liaison between the sponsor and site staff, providing timely updates and training as needed.
* Conduct source data verification (SDV) and ensure data accuracy in all systems.
* Support safety reporting by tracking and managing adverse events (AEs) and serious adverse events (SAEs).
* Document visit findings through clear and timely reports and follow-up correspondence.
* Maintain oversight of site documentation, including regulatory binders and monitoring files.
* Contribute to subject recruitment planning and site engagement strategies.
* Attend internal project meetings, highlighting site progress and raising any concerns.
* Support audit readiness and facilitate the resolution of site-level issues.
Required Experience/Skills for the ClinicalResearch Associate (West Coast):
* Minimum of 5 years of experience as a ClinicalResearch Associate, with demonstrated success in site monitoring.
* Strong knowledge of ICH-GCP and regulatory requirements.
* Ability to manage multiple sites and travel up to 80%.
* Experience with clinical trial management systems (CTMS), EDC platforms, and Microsoft Office.
* Excellent organizational, analytical, and communication skills.
Education Requirements:
* Bachelor's degree in a scientific discipline, Nursing, or an equivalent field is required.
Benefits:
* Competitive compensation package.
* Health, dental, and vision insurance.
* 401(K) with company matching.
* Paid time off and holidays.
* Full travel reimbursement and per diem.
* Career development and training opportunities.
$100k-120k yearly 12d ago
Senior Clinical Trial Associate
Apogee Therapeutics
Remote clinical research monitor job
About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. If this sounds like you, keep reading! Role Summary
We are seeking a Sr. Clinical Trial Associate (Sr. CTA) role, who will support 1-3 project teams. In this role you will manage multiple administrative aspects of clinical trials across all project stages, including study start-up, enrollment, study conduct and close-out. This may include creation of study documents, implementing and maintaining trackers, coordinating vendor payments and supplies to research units, performing quality control of clinical trial documents and assisting with study start-up contracting and study coordination activities. This role will also have accountability for managing the collection, review, completeness, and quality of their assigned eTMFs.
Key Responsibilities
Act as a central contact for the cross-functional study team for designated project communications, correspondence, and associated documentation
Maintain and perform QC reviews on study specific electronic Trial Master Files to ensure inspection readiness and compliance with applicable regulations and Good Clinical Practices
Track and report study metrics; inclusive of start-up, data management, and contracting as needed
Participate in GxP audits and related clinical compliance activities
Prepare and track study documents (e.g., contracts, budgets, IRB documentation)
Maintain databases/spreadsheets, as necessary, to facilitate tracking/documentation of departmental activities (e.g., CRFs, queries, and clinical data or sample flow, etc.) and assist in ensuring all systems, including but not limited to, EDC (Data Management), eTMF, CTMS, Payments, etc. are best utilized per Quality standards
Administer user access and change control within Apogee's electronic systems
Assist in User Acceptance Testing for all EDC needs in regard to Data Management and all Clinical Systems
Assist with vendor management and associated logistics, as assigned
Contribute to the creation of presentations, as needed for project, departmental, sponsor and/or business development presentations
Collaborate with Clinical Project Manager, Clinical Supply Unit and QA in order to manage activities related to Clinical Supplies. Manage study related payment procedures. Interact with external providers during study conduct (CROs, monitors and, occasionally, with investigators and Hospital personnel). May accompany CRAs on site visits to assist with clinicalmonitoring duties upon completion of required training.
Organize and/or participate in meetings with CROs. Ensure appropriate meeting minutes are prepared and filed in TMF
Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
Assist in creating and implementing departmental procedures Assist with information gathering, literature searches, and creation of presentations, as needed
Responsible for managing team training assignments and oversight/ownership of due dates to support compliance
Ideal Candidate
BS/BA in Life Sciences or equivalent
4+ years of experience in similar position in Biotech, Pharmaceutical or CRO industry and in R&D environment
Extensive experience with TMF, including set-up, maintenance, QC/ QR and query management. Familiar with DIA reference model
Knowledge of ICH/GCP and applicable regulations
Demonstrated proficiency in written, verbal and face-to-face communication to effectively present information to and influence decision making of managers, working partners (local and global)
Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining high attention to detail and responding to rapidly changing priorities and aggressive deadlines
Proficient in MS Office (Word, Excel, Project), Adobe, SmartSheet, and ISI Toolbox
Strong critical thinking, organizational and time-management skills
Successfully exhibit Apogee's C.O.R.E. values: Caring, Original, Resilient and Egoless
Position requires up to 15-20% travel,including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year. Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences.
The anticipated salary range for candidates for this role will be $130,000 - $145,000 per year.The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
What We Offer
A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve
E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. A
pogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
To review our privacy policy, click here
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$130k-145k yearly Auto-Apply 15d ago
Clinical Research Associate
Histosonics 3.6
Remote clinical research monitor job
HistoSonics is a medical device company, founded in 2009, that has developed a non-invasive, sonic beam therapy platform that uses histotripsy, which is capable of destroying targeted liver tumors. Our mission and passion are to advance the novel science of histotripsy and its powerful benefits, bringing meaningful and transformational change to physicians and their patients.
Location: Remote position, ideally candidates will live in a major metro area with an international airport in the Northeast, Southeast or West Coast.
Travel Expectation: Travel (by automobile or air, day trips and overnight stays) up to 30% of the time.
Position Summary:
The ClinicalResearch Associate will play a key role in proactively helping the conduct of pre-market and post-market global clinical studies to ensure compliance with all the regulatory requirements and company strategic initiatives. As a member of the Clinical Affairs team, this role will work with key stakeholders to execute clinical studies. This role will be responsible for study site management, including site qualification, training, activation, and monitoring.
Key Responsibilities:
* Works on assigned studies to ensure that human subject protection is maintained in accordance with Good Clinical Practice (GCP), SOPs, and applicable regulations
* Conducts on-site and remote site qualification, initiation, interim, and close-out monitoring visits
* Serve as primary point of contact for site questions relating to study enrollment and conduct; collaborate with appropriate study team members as needed
* Assists with the development and execution of clinical study documents including protocols, informed consents, case report forms, and study plans
* Communicates through verbal and written communication with site investigator and the project team on the overall site performance, trends, deficiencies, and concerns
* Ensures quality and completeness of central and site master files
* Oversees site investigational product requirements and device accountability
* Supports the planning and coordination of Investigator Meetings
* Other duties as assigned
Qualifications and Skills:
* 2+ years clinicalresearch study monitoring for medical device or related experience
* BS degree in relevant area of study
* Knowledge of federal and local regulations and policies pertinent to research involving human subjects
* Knowledge of ICH, GCP and Declaration of Helsinki
* Excellent communication, interpersonal and organizational skills
* Ability to collaborate in a team environment and work independently
* Self-starter with the ability to manage projects and effectively prioritize tasks in a dynamic, start-up environment
* Must be willing and able to travel (by automobile or air, day trips and overnight stays) up to 30% of the time
HistoSonics will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Benefits: We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
#LI-Remote
$55k-90k yearly est. 43d ago
Clinical Research Associate- Remote
Icon Clinical Research
Remote clinical research monitor job
ClinicalResearch Associate ICON plc is a world-leading healthcare intelligence and clinicalresearch organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a ClinicalResearch Associate to join our diverse and dynamic team. As a ClinicalResearch Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
**What you will be doing**
+ Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
+ Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
+ Collaborating with investigators and site staff to facilitate smooth study conduct.
+ Performing data review and resolution of queries to maintain high-quality clinical data.
+ Contributing to the preparation and review of study documentation, including protocols and clinical study reports
**Your profile**
+ Bachelor's degree in a scientific or healthcare-related field.
+ Minimum of 2 years of experience as a ClinicalResearch Associate.
+ In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
+ Strong organizational and communication skills, with attention to detail.
+ Ability to work independently and collaboratively in a fast-paced environment.
+ Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, 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
$56k-88k yearly est. 50d ago
Remote Women's Fertility Clinical Research Associate III
Global Channel Management
Remote clinical research monitor job
Remote ClinicalResearch Associate III needs 2 years of site management and field monitoring experience
Remote ClinicalResearch Associate III requires:
Work Schedule: M-F 7:00 am -3:30 pm or 8:00 am to 4:30 pm
EST
Qualifications:
BS/BA
Minimum of 2 years of site management and field monitoring experience
Knowledge of applicable standards and regulations for clinical trials
Proven oral and written communication skills
Proven planning skills; ability to create and track detailed project plans
Proven interpersonal, leadership, organizational and effective time management skills
Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates
Ability to work independently and within a cross-functional team environment to identify and escalate site/monitoring related activities issues to the management team in a timely fashion
Preferred:
Experience in womens fertility
VD Study Experience
Medidata RAVE system
Remote ClinicalResearch Associate III duties:
Performs Site initiation, interim & close out monitoring visits
Verifies required clinical data entered in the electronic case report form (eCRF) is accurate and complete
Manages site communication and escalates to leadership in a timely fashion when needed
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).
Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
Documents activities via confirmation letters, follow-up letters, trip reports
Site support throughout the study lifecycle from site identification through close-out Attends and participates in internal meetings
$50k-80k yearly est. 60d+ ago
Sr. Clinical Trial Associate
Allen Spolden
Remote clinical research monitor job
The remote -based Clinical Trial Associate (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 ClinicalResearch Organizations (CROs) to support clinical study activities as defined by the clinical trial 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 clinical trial 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, clinicalresearch 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 clinicalresearch.
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 Study Manager-Remote
Artech Information System 4.8
Remote clinical research monitor 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 Title: Clinical Study Manager-Remote
Location: Collegeville, PA
Duration: 36 months
Job Description:
This position is needed to assist with Inspection Readiness Prepartion. The candidate will need to assist in leading diverse CRO teams through the Inspection Readiness process. Strong pTMF experience is also desired. A large component of the position will be to search for documents in pTMF and work with 2 different CRO to ensure that all documents are present in pTMF. Strong understanding of clinical trial documents is needed as well as a thorough understanding of a sponsor Inspection. The candidate should be flexible and able to positvely influence CRO staff while meeting the needs of the business. The candidate will also be asked to assist with filing protocol amendments in pTMF, ICD updates, and helping the COSTL and Clinican with tasks on an ad hoc basis.
The candidate will lead 2 CROs through Inspection Readiness Activities for a large, high visibility, global oncology protocol that is in submission.
The candidate needs to be able to influence and lead the 2 CROs through the Inspection Readiness checklist (~500 items). All items on the checklist will need to be reviewed, the location of the documents will need to be identified and entered onto the checklist. The candidate will need to be able to navigate through pTMF to ensure all documents are in pTMF in the correct cabinet and folder. The candidate will need to be proficient at searching for documents such as Monitoring Visit Reports, Financial Disclosure Documents, SOPs, vendor oversight plans. The candidate will need to compile a listing of relevant SOPs used on the study both past and present and download those SOPs into folders on a sharepoint space.
The candidate will need to be comfortable leading 2 CROs in document retrieval and ensuring all Inspection Readiness Documents are up to date with the correct versions. The candidate will need to work with the 2 CROs for any corrections or updates needed.
Additional Skills:
pTMF, Inspection Readiness activities, Study conduct activities.
Qualifications
BS
Additional Information
For More information, Contact
Best Regards,
Akriti Gupta
**************
Morristown, NJ 07960
$66k-97k yearly est. 60d+ ago
Clinical Research Associate- Remote
Ire
Remote clinical research monitor job
ClinicalResearch Associate
ICON plc is a world-leading healthcare intelligence and clinicalresearch organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
We are currently seeking a ClinicalResearch Associate to join our diverse and dynamic team. As a ClinicalResearch Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
What you will be doing
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
Collaborating with investigators and site staff to facilitate smooth study conduct.
Performing data review and resolution of queries to maintain high-quality clinical data.
Contributing to the preparation and review of study documentation, including protocols and clinical study reports
Your profile
Bachelor's degree in a scientific or healthcare-related field.
Minimum of 2 years of experience as a ClinicalResearch Associate.
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
Strong organizational and communication skills, with attention to detail.
Ability to work independently and collaboratively in a fast-paced environment.
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
$51k-76k yearly est. Auto-Apply 52d ago
Clinical Research Associate (CRA)
Peachtree Bioresearch Solutions
Remote clinical research monitor job
Peachtree BioResearch Solutions, a Julius Clinical Company, is a global specialized full-service CRO providing highly specialized study operations teams for pharmaceutical, biotech, and medical device companies. Formed over 15 years ago by a pharma leadership team experienced in
buying
CRO services with the purpose of creating trusting partnerships with sponsor clients - no matter their budget. We do this by investing in people who thrive in an environment where their experience and contributions can be felt throughout the organization. It's an exciting time as we expand our global reach, while still offering a personalized approach to sponsors and delivering incredible value.
Peachtree Bioresearch Solutions is a fast growing, full-service ClinicalResearch Organization with expertise in CNS and other therapeutic areas. We create strong, consultative relationships with sponsor clients and we're looking to add CRAs who are dedicated, want to make an impact, and enjoy having visibility across the entire project beyond their monitoring role.
As a small/mid CRO, we focus on building great teams where all ops functions can provide a high level of service. You can see the impact you make, and get recognized for it. It's also fun working with others who are very good at what they do.
Responsibilities:
Work closely with the Site Management team and sponsor stakeholders so you can plan and manage your work most effectively
Perform site selection, initiation, monitoring and close-out visits, plus maintain the appropriate documentation
Establish relationships with sites while administering protocol and related study training
Work with Peachtree's Data Management team and sites to ensure all queries are resolved
Complete all reports and follow up items in a timely manner
Work with project leadership to customize solutions that bring value to the sponsor
Qualifications:
Bachelor's degree
1-5 years of experience working on clinical trials (CRO or Sponsor) with at least a year of site monitoring
Experience on CNS or neuro studies highly desirable
Willing to travel 65%. Sometimes it's hectic. Sometimes it's not. We do a good job trying to manage it.
Highly proficient with business software (MS365)
Experience working in a CTMS and EDC system
Excellent organizational and critical thinking skills
Excellent written and verbal communication and presentation skills
Be resourceful and curious - you figure out problems and think about the business beyond the task at hand.
A team player who elevates others
Leadership traits and attitude
In addition to working with great people on high performing teams,
full-time employees
receive:
Medical, Dental, Vision, Life, Disability coverage
20 days PTO + PTO rollover + 13 paid holidays
401(k)
$51k-76k yearly est. Auto-Apply 60d+ ago
Clinical Research Associate- Remote
Icon Central Laboratories
Remote clinical research monitor job
ClinicalResearch Associate
ICON plc is a world-leading healthcare intelligence and clinicalresearch organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
We are currently seeking a ClinicalResearch Associate to join our diverse and dynamic team. As a ClinicalResearch Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
What you will be doing
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
Collaborating with investigators and site staff to facilitate smooth study conduct.
Performing data review and resolution of queries to maintain high-quality clinical data.
Contributing to the preparation and review of study documentation, including protocols and clinical study reports
Your profile
Bachelor's degree in a scientific or healthcare-related field.
Minimum of 2 years of experience as a ClinicalResearch Associate.
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
Strong organizational and communication skills, with attention to detail.
Ability to work independently and collaboratively in a fast-paced environment.
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
$51k-76k yearly est. Auto-Apply 52d ago
Clinical Research Associate (PhD Candidates)
Medpace 4.5
Remote clinical research monitor job
Join our CRA Team in Cincinnati, Ohio! The ClinicalResearch 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 clinicalresearch 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, Clinical Trial 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, clinicalresearch 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 Clinical Trial 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 clinicalresearch 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.
$49k-80k yearly est. Auto-Apply 60d+ ago
Clinical Research Associate- Remote
Icon Plc 4.8
Remote clinical research monitor job
ClinicalResearch Associate ICON plc is a world-leading healthcare intelligence and clinicalresearch organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a ClinicalResearch Associate to join our diverse and dynamic team. As a ClinicalResearch Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
What you will be doing
* Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
* Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
* Collaborating with investigators and site staff to facilitate smooth study conduct.
* Performing data review and resolution of queries to maintain high-quality clinical data.
* Contributing to the preparation and review of study documentation, including protocols and clinical study reports
Your profile
* Bachelor's degree in a scientific or healthcare-related field.
* Minimum of 2 years of experience as a ClinicalResearch Associate.
* In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
* Strong organizational and communication skills, with attention to detail.
* Ability to work independently and collaboratively in a fast-paced environment.
* Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
* Various annual leave entitlements
* A range of health insurance offerings to suit you and your family's needs.
* Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
* Global Employee Assistance Programme, 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
$48k-70k yearly est. 51d ago
Clinical Research Scientist Interventional Solutions
Gehc
Remote clinical research monitor job
SummaryAre you looking to make meaningful impact with your research/technical experience? Working daily in close partnership with Interventional key clinical partners - as well as global and local GE Healthcare colleagues - you will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job DescriptionResponsibilities
Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities.
Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership (contributing to letters of support, research proposals, supporting identified grant submissions).
Support adoption of new technology or clinical applications through advocacy and evidence.
Participate in customer presentations regarding use of Interventional products for institution research purposes.
Closely connected with GEHC global modality clinical and R&D teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs.
Collect data, clinical & product feedback, technical study endpoints, DICOM images and annotations
Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns.
Grow technology leadership mindshare through joint scientific presentations and publications.
Install/upgrade research equipment and software & prototypes
Lead GE Interventional solutions evaluation and optimization for emerging interventional procedures
Represent the global modality technical, scientific and product expertise in USCAN to support local clinical teams and best-in-class customer experience on new products.
Study new technology concepts and leverage expertise to move initiatives forward.
Note:
No sponsorship available for this role now or in the future to work in the United States..
Qualifications
PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field.
3+ years of experience in Interventional healthcare industry or research.
Knowledge of Interventional procedures, anatomies, clinical practice.
Excellent written and verbal communication skills.
Excellent customer relationship management and collaboration skills.
Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas.
Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task.
Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams.
Able to individually lead complex projects with autonomy, rigor, drive & competence
Ability to travel (
Quality, Compliance, and Continuous Improvement focus
Desired Characteristics
5 years' experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics.
Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department)
Demonstrated record of innovation and development.
History of publications, clinical/non-clinical experiments, knowledge in statistics
Programming / Image processing experience
Experience with academic and/or clinicalresearch collaborations
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.
#LI-BR3
#LI-Remote
We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $97,600.00-$146,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.Additional Information
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
$97.6k-146.4k yearly Auto-Apply 43d ago
Global Trial Associate- Global Clinical Operations Leadership Development Program (GCO-LDP)- Full-Time Class of 2026
8427-Janssen Cilag Manufacturing Legal Entity
Remote clinical research monitor job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
R&D Operations
Job Sub Function:
Clinical Trial Project Management
Job Category:
Professional
All Job Posting Locations:
Irvine, California, United States of America, Los Angeles, California, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, United States of America
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at *******************/innovative-medicine
Remote work options may be considered on a case-by-case basis and if approved by the Company.
We are searching for the best talent for the Global Trial Associate- Global Clinical Operations Leadership Development Program (GCO-LDP)- Full-Time Class of 2026.
Purpose: The GCO Leadership Development Program consists of 12 months of dynamic rotations in Spring House, PA and Southern California locations (e.g Los Angeles, Irvine, San Diego). The Program provides in-depth training across the Clinical Trial Assistant, Site Manager, and potentially Local Trial Manager based on business need, supported by strong line management, formal mentorship, sponsorship, networking, focused leadership development and dynamic real world work experience.
Global Trial Associates (GTAs) will rapidly gain knowledge, develop technical and leadership skills and important insights into how the business operates. These positions will be in the Immunology and Cross (e.g. Neuroscience, Retinol, and others) Therapeutic Areas. These positions will not be in the Oncology Therapeutic area.
The objective is for the GTA to develop an understanding of pharmaceutical development, GCO standard operation procedures, policies and regulatory requirements, logistical and administrative tasks related to trial management (start-up, execution and closing phases) and patient safety in clinical trials.
The GTA will gain knowledge of and support activities of the Site Manager (SM) and Program Manager, and/or Manager Clinical Operations (MCO). GTA's will support Local Trial Manager (LTM) positions under the direct supervision of LTM and SM mentors if there is a business need.
Upon successful completion of the program, GTAs will be placed in a Site Manager role or potentially a Local Trial Manager role depending on business need and skillset. The GCO US Site Management organization is regionally aligned to the Northeast, Southeast, Central and West. This reduces the travel burden for Site Managers as they are assigned to study institutions based in their region.
Local Trial Managers work remotely and are not regionally aligned as they don't have travel associated with their position. LTMs are project managers responsible for study deliverables in the US. Following completion of the program, GTAs moving into the SM role will work remotely in an assigned region in the U.S., where there is a business need.
You will be responsible for:
Provide administrative and logistical support to Clinical Trial Assistant (CTAs), Site Manager and/or Local Trial Manager in tracking progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence, materials, drug distribution and other relevant tasks as appropriate in adherence to relevant SOPs, policies, and local regulatory requirements.
Support the local study team in performing site feasibility and/or country feasibility. Collaborates with the Global Project Team, e.g. Trial Delivery Manager (TDM)/Trial Delivery Lead (TDL), local management/Country Head and other study team members, as required.
Maintain information in relevant systems, including electronic filing (electronic Trial Master File: eTMF).
Ensure current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes, as applicable.
Support Trial Delivery Manager, Site Manager and/or Local Trial manager in collecting/preparing documents required for study start-up/ submission to Ethics Committee/IRB and/or Health Authorities.
Support Trial Delivery Manager, Site Manager and/or Local Trial Manager in collecting, processing, and archiving study related documents as appropriate. Use appropriate systems to ensure file completeness at designated study milestones.
May assist team in conducting local investigator meeting or with planning for the investigators participating in an international meeting.
Maintain and update contact information in relevant systems to ensure appropriate safety updates distribution.
Comply with all training requirements, company policies & procedures and all applicable laws and regulations. Always act aligned with J&J Credo.
Ensure inspection readiness at all times.
May contribute to process improvement.
Support Site Manager, within a reasonable timeframe, be able to take on responsibility in executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/ study close-out according to Standard Operating Procedures, Work Instructions (WIs) and policies.
Qualifications / Requirements:
Must be graduating between December 2025 and July 2026 with a bachelor's or master's degree (e.g., BA, BS, MS) in Health Sciences or a related scientific field (we will not be accepting PhD/Pharm D or Pre-Med applicants)
Minimum GPA of 3.5 is required
1+ year of professional work experience is preferred (including internship, co-op or research experience)
Ability to relocate to:
Spring House, PA and work full-time (hybrid 3 days on-site/2 days remote) for the duration of the 1-year program
California locations and work full-time for the duration of the 1-year program (hybrid and/or remote schedule will be determined on an individual basis)
Geographic flexibility to relocate within the U.S. following completion of the program, if there is a business need
Ability to travel as needed in the Site Manager rotation
Permanently authorized to work in the United States, must not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually require future sponsorship for long term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship.
Skills:
Strong verbal and written communication and presentation skills
Analytical and a real problem solver
Willingness to learn in a dynamic environment and stay abreast of new technologies
Strong interpersonal, leadership, and negotiating skills
Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
Ability to perform activities in a timely and accurate manner.
Expert proficiency with Word, Power Point, Excel.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs:
Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Employees are eligible for the following time off benefits:
Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
Holiday pay, including Floating Holidays - up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on Company benefits, please go to: *********************************************
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid #LI-Remote #LI-Onsite
Required Skills:
Analytical Thinking, Microsoft Excel, Negotiation, PowerPoint Presentations, Problem Solving, Time Management
Preferred Skills:
Analytical Reasoning, Clinical Data Management, ClinicalResearch and Regulations, Clinical Trial Designs, Clinical Trials
The anticipated base pay range for this position is :
$95,600/year
Additional Description for Pay Transparency:
This position is eligible for a sign-on bonus. Eligibility for severance.
$95.6k yearly Auto-Apply 17d ago
Clinical Trial Contracts Associate I
Stratacuity
Remote clinical research monitor job
Clinical Trials Contracts Associate I (Remote) Rate: $25-$30/hour | Fully Remote We are seeking a Clinical Trials Contracts Associate I to join our team and support the contracting process for clinical trials. 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 clinical trial contracts and related documentation.
* Collaboration: Work closely with clinicalresearch 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, clinical trials, 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 clinicalresearch 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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Senior Clinical Trial Specialist - Remote Position
Puma Biotechnology, Inc. 4.3
Remote clinical research monitor job
The Senior Clinical Trial Specialist (Sr. CTS) is responsible for providing operational support for the day-to-day execution of clinical trials, 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 clinical trial 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 clinical trial 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 clinical trial documentation and study status in an electronic system; manages and tracks regulatory/IRB/IEC documentation, IND safety letter distribution, confidentiality disclosure agreements, and other clinical trial 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 clinical trial 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 clinical trial-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 ClinicalMonitoring 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 ClinicalMonitoring Plan and SOPs
* Mentors more junior staff
* Manages study team meetings in absence of Clinical Trial 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 Clinical Trial Specialist experience or commensurate
Preferred:
* One year of clinicalresearch 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 14d ago
Clinical Research Coordinator I
St. Charles Health System 4.6
Remote clinical research monitor job
This position may be filled at the coordinator level 1 or level 2, based on experience/qualifications and requires the incumbent to reside in Central Oregon: Level 1 Pay range: $25.18 - $37.77 per hour. Level 2 Pay range: $27.20 - $40.79 per hour.
St. Charles Health System is a leading healthcare provider in Central Oregon, offering a comprehensive range of services to meet the needs of our community. We are committed to providing high-quality, compassionate care to all patients, regardless of their ability to pay. Our values of compassion, excellence, integrity, teamwork, and stewardship guide our work and shape our culture.
What We Offer:
Competitive Salary
Comprehensive benefits including Medical, Dental, Vision for you and your immediate family
403b with up to 6% match on Retirement Contributions
Generous Earned Time Off
Growth Opportunities within Healthcare
ST. CHARLES HEALTH SYSTEM
JOB DESCRIPTION
TITLE: ClinicalResearch Coordinator I
REPORTS TO POSITION: Research Manager
DEPARTMENT: Research
DATE LAST REVIEWED: November 15, 2024
OUR VISION: Creating America's healthiest community, together
OUR MISSION: In the spirit of love and compassion, better health, better care, better value
OUR VALUES: Accountability, Caring and Teamwork
DEPARTMENTAL SUMMARY: St. Charles Research Department conducts clinical trials for promising new treatments and therapies in a wide variety of medical fields, including cancer treatment and prevention, cardiovascular disease and supportive care.
POSITION OVERVIEW: The ClinicalResearch Coordinator I is responsible for conducting clinical trials in compliance with FDA regulation, ICH Guidelines and applicable industry standards. The ClinicalResearch Coordinator 1 will oversee up to ten clinical trials as the main research coordinator.
This position does not directly manage other caregivers, however may be asked to review and provide feedback on the work of other caregivers.
ESSENTIAL FUNCTIONS AND DUTIES:
Maintains surveillance system to identify potential subjects for study eligibility, prescreen patients, and assists physicians in determining eligibility.
Obtains informed consent according to GCP and ICH guidelines.
Performs study procedures and assessments following protocol specific guidelines.
Assures research is conducted in an ethical and safe manner according to FDA, ICH and St. Charles Health System guidelines.
Adheres to St. Charles Health System's compliance plan.
Attends IRB meetings as requested by the IRB.
Supports the processing of study alerts, protocol revisions, amendments, accrual suspension notices, informed consent modifications, product information and advertisement, and related memoranda.
Supports the modification of template informed consent forms for local application in compliance with federal guidelines for patients in lay language at appropriate reading level
Prepares for and participates in required sponsor and regulatory audits.
Attend Investigator meetings as required to assure seamless study start-up.
Assists with subject education and informed consent process, including tissue and genetics consent when indicated. Surveys for re-consent and obtains from eligible subjects.
Educates patients regarding protocol diagnostic tests and assists with appointments.
Process tissue/blood specimens and prepare it for shipment.
Manages treatment and follow-up schedules to assure protocol compliance.
Attends subject clinic visits and interacts with subjects and staff as appropriate to assist in protocol adherence.
Track study drug usage per protocol and oversee study drug supply.
Maintains subject research records including long-term follow up and reporting.
Participates in institutional research activities (committee meetings, Tumor Boards, Grand Rounds, other conferences, etc.) that are relevant to the Position.
Keeps current with new developments in research methodologies.
Participates in quality assurance program for St. Charles Health System and affiliated research partners.
Supports the vision, mission and values of the organization in all respects.
Supports Value Improvement Practice (VIP- Lean) principles of continuous improvement with energy and enthusiasm, functioning as a champion of change.
Provides and maintains a safe environment for caregivers, patients and guests.
Conducts all activities with the highest standards of professionalism and confidentiality. Complies with all applicable laws, regulations, policies and procedures, supporting the organization's corporate integrity efforts by acting in an ethical and appropriate manner, reporting known or suspected violation of applicable rules, and cooperating fully with all organizational investigations and proceedings.
Delivers customer service and/or patient care in a manner that promotes goodwill, is timely, efficient and accurate
May perform additional duties of similar complexity within the organization, as required or assigned.
EDUCATION:
Required: Bachelor of Science degree, or combination of college level education and Research experience to perform the full scope of position duties.
Preferred: Bachelor of Science degree in related field.
LICENSURE/CERTIFICATION/REGISTRATION
Required: Association of ClinicalResearch Professional (ACRP) or Society of Clinicalresearch Associates (SOCRA) certification or must obtain within 2 years of full time employment. Current American Heart Association (AHA) Basic Life Support for Healthcare Provider certification.
Preferred: N/A
EXPERIENCE:
Required: None Required.
Preferred: Experience as a ClinicalResearch Coordinator. Experience dealing with multidisciplinary teams. Basic Clinical task knowledge.
ADDITIONAL POSITION INFORMATION: N/A
Schedule Weekly Hours:
40
Caregiver Type:
Regular
Shift:
First Shift (United States of America)
Is Exempt Position?
No
Job Family:
COORDINATOR CLERICAL
Scheduled Days of the Week:
Monday-Friday
Shift Start & End Time:
Variable