Senior Clinical Research Specialist Job at Imricor Medical Systems (Burnsville)

Senior Clinical Research Specialist

As a community, the University of Rochester is defined by a deep commitment to M...

Location

United States of America , Rochester

Salary:

60431.00 - 84603.00 USD / Year

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor's degree and 3 years of relevant experience required
Ability to effectively manage complex research protocols/procedures required
Fully adheres to applicable safety and/or infection control standards
Proficiency in medical terminology, the clinical research process, and applicable regulatory guidelines, standards preferred
Proficiency in managing multiple and competing priorities/demands
Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, and OSHA guidelines throughout study implementation
Exceptional interpersonal, organizational, and time management skills
highly collaborative, promotes teamwork
Ability to build collaboration among research team members, laboratory staff, patients, and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients)
Proficient in MS Office (e.g., Word, Excel, and PowerPoint), email, and internet

Job Responsibility

Provides leadership in planning, implementing, monitoring, and evaluating multiple clinical research protocols
Manages the day-to-day operations of multiple studies, carrying out study coordination duties from protocol development and initiation through to study close-out in accordance with regulatory/sponsor guidelines
Monitors and maximizes adherence to research standards, regulatory guidelines, and approved operational procedures
Works closely with study team members and other study sites to ensure the safety and adherence of study participants to the study protocol
Manages study-related administrative and human resources tasks and facilitates across-the-board flow of information, orchestrating study activities and personnel
Coordinates enrollment of participants
Oversees and facilitates eligibility screening and study recruitment activities
Plans study timelines and schedules appointments and study visits
Manages and organizes case report forms, source documents, and research records
Enters research data into data collection forms and/or study databases

Fulltime

Senior Contract Specialist, Clinical Research Agreement

At Boston Children’s Hospital, the quality of our care – and our inclusive hospi...

Location

United States , Boston

Salary:

69888.00 - 111831.20 USD / Year

Boston Children's Hospital

Expiration Date

Until further notice

Requirements

Bachelor’s degree
2+ years of relevant experience
Identifies and resolves highly complex ethical, and/or operating problems
Ability to effectively negotiate with peer level department heads and/or with external agencies/facilities on issues and programs that impact department as well as several other large departments/divisions.

Job Responsibility

Drafts and negotiates written clinical research related agreements with corporate sponsors and other outside entities
Conducts negotiation of complex clinical research agreements and attends to relevant terms
Assures timely completion of negotiation proceedings
Acquires and maintains knowledge of Hospital’s policies and procedures applicable to clinical sponsored research and, applicable Harvard faculty policies and, other academic and professional standards for the conduct and administration of clinical sponsored research
Acquires understanding of corporate sponsor interests and of the regulatory environment and requirements for the research and development of products for market approval
Develops functional understanding of the business needs of the hospital administrative and research staff for the effective conduct and administration of clinical corporate sponsored research arrangements
Evaluates and makes recommendations for systems, policies and procedures to promote effective interaction between the hospital and industry for mutual benefit
Identifies, prioritizes and implements policy, programmatic and administrative procedural changes to enhance operational efficiency and effectiveness
Advises faculty on BCH and sponsor requirements for clinical corporate sponsored research agreements
Reviews all agreements and payment terms within budgets to ensure conformance with Hospital policies

What we offer

flexible schedules
affordable health, vision and dental insurance
child care and student loan subsidies
generous levels of time off
403(b) Retirement Savings plan
Pension
Tuition and certain License and Certification Reimbursement
cell phone plan discounts
discounted rates on T-passes

Fulltime

Senior Clinical Research Associate II - FSP

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

Turkey

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Senior Physician, Patient Safety

Join our dynamic Patient Safety team as a Senior Physician where you'll leverage...

Location

United States; Canada , Remote; Alberta

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
Good knowledge of drug safety and the drug development process
Good knowledge/understanding of medical terminology
Relevant experience in pharmacovigilance/ Drug Safety/ Clinical Practice
3 - 5 years previous experience in pharmacovigilance and/or medical monitoring is required
US Board Certification/board eligibility or regional equivalent for Canada
Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School
Completion of at least basic training in clinical medicine (residency, internship etc.)
Demonstrated success in technical proficiency and scientific creativity
Good presentation and verbal/written communication skills

Job Responsibility

Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs
as applicable) and liaising with the client, as require
Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
Review appropriateness of medical content in narrative for medical coherence
Assessing seriousness, listedness / expectedness of reported events
Providing medical inputs to case processing team
Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)
Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative

What we offer

Flexible approach to work that meets your personal needs
Work from home
Benefits vary by country
Investment in your professional and personal development

Radiation Therapist Senior

The role is responsible for the provision of services in line with standards of ...

Location

Ireland , Lucan, Co. Dublin

Salary:

Not provided

Blackrock Health Hermitage Clinic

Expiration Date

Until further notice

Requirements

Possess appropriate qualification in Radiation Therapy: BSc Radiation Therapy
Be registered with the Radiographers Registration Board – CORU
Have satisfactory post qualification experience and have proven clinical expertise
Have experience of or be prepared to participate in research

Job Responsibility

Demonstrate evidence based practice through decision making and apply it to complex cases
Ensure that the Radiotherapy service delivered to patients meets professional and European standards of practice
Provide advice and support to Radiotherapy and multidisciplinary colleagues on clinical practice issues
Provide clinical leadership and instruction
Be accountable for the treatment unit
Maintain accurate information systems for clinical data in accordance with departmental and hospital policies
Conduct on treatment assessment of patients
Assessment of pre-treatment images and approval of verification images
In depth assessment of treatment plan
Final confirmation of radiotherapy treatment with specified time frame

What we offer

An Education Support Programme
Family Friendly hours available
Development opportunities
Opportunities for career progression
Access to a Pension Scheme
Subsidised Restaurant
Free staff car parking
Employee Assistance Programme
Life Assurance

Fulltime

Senior Clinical Research Specialist

Are you a clinical research professional looking to make a significant impact in...

Location

Belgium , Zaventem

Salary:

Not provided

Randstad

Expiration Date

April 25, 2026

Requirements

Minimum of a Bachelor’s degree in Life Sciences, Nursing, or a related Biological science
BS with 4+ years, MS with 3+ years, or a PhD with 2+ years of relevant clinical research experience
A strong background in the pharmaceutical or MedTech industry is required
Specific experience in Cardiology or Electrophysiology is highly preferred
Deep knowledge of ICH-GCP guidelines and global clinical trial regulations
Fluent in English (written and oral)
proficiency in other European languages is a distinct advantage
You are proactive, assertive, able to prioritize effectively, and thrive in a collaborative team environment
Willingness to travel approximately 20-25% for site visits and international collaboration

Job Responsibility

Manage the set-up, conduct, and closure of clinical trials in accordance with ICH-GCP, MDR, and company SOPs
Serve as the primary contact for clinical trial sites and foster strong relationships with investigators, IRBs/ECs, and external vendors
Contribute to the creation of essential study documents, including protocols, informed consents, CRFs, and monitoring plans
Oversight of Clinical Research Associates (CRAs) and performing site visits (qualification, initiation, monitoring) as required by study needs
Perform clinical data reviews for statistical analysis and potentially act as a Clinical Safety Coordinator to manage adverse event reporting and safety management plans
Lead small study teams to deliver milestones on time and within budget, while mentoring junior team members

Senior CT Radiographer

The Senior CT Radiographer is required to provide a first class clinical and pro...

Location

Ireland , Lucan, Co. Dublin

Salary:

Not provided

Blackrock Health Hermitage Clinic

Expiration Date

Until further notice

Requirements

BSc in Radiography
CORU registration
Minimum of 4 years’ experience with at least two years in CT
Qualified to administer I.V. contrast
Familiar with a computerised patient information system and PACS
The ability to interact effectively with multidisciplinary staff members within the Hermitage Clinic
Thorough understanding of legislation relating to CT and Radiation Safety
Understand the requirements of and promote CPD

Job Responsibility

To undertake all CT procedures with a specialist standard of technical skill, efficiency and patient care in accordance with departmental protocols and procedures
Ensure that procedures and protocols are safe and offer the best possible imaging results with the lowest dose achievable for all patients
To continually train, supervise and update the radiographic staff to ensure Best Practice and a competent and confident work force
Be responsible for the use of IV contrast agent administration
Ensure IV training and monitoring procedures are in place (training to include anaphylaxis reactions) and performing IV contrast administration cannulation
Adapt the service to respond to long and short term demands
Work with colleagues and Clinical Specialists to ensure the daily workload is organised in line with clinical priorities
Excellent communication skills needed to liaise with both staff within the department, throughout the hospital and various external sources in order to provide a quality service to patients and clinicians
Knowledge of the HIQA regulations pertaining to ionising radiation
Be familiar with and understand the Clinic’s policies and procedures in relation to Infection Control, Fire, Health and Safety at Work regulations and to attend mandatory training

What we offer

An Education Support Programme
Family Friendly hours available
Development opportunities
Opportunities for career progression
Access to a Pension Scheme
Subsidised Restaurant
Free staff car parking
Employee Assistance Programme
Life Assurance

Fulltime

New

Senior Clinical Trial Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Advanced degree or certification in a relevant field such as life sciences, healthcare, or clinical research
Extensive experience in a clinical trial support role, with a solid understanding of clinical trial processes and regulatory requirements
Strong organizational and multitasking skills, with the ability to manage multiple tasks and projects effectively
Proficiency in clinical trial management systems and relevant software, with a keen eye for detail in documentation and data management
Excellent communication, interpersonal, and problem-solving skills, with the ability to work collaboratively with diverse teams and stakeholders

Job Responsibility

Providing administrative support for clinical trials, including managing documentation, coordinating meetings, and maintaining trial-related records
Assisting in the preparation and submission of regulatory documents and ensuring compliance with study protocols and regulatory requirements
Collaborating with cross-functional teams to support trial operations and resolve any issues that arise during the course of the study
Monitoring and tracking trial progress, including managing site communications and ensuring timely delivery of study materials
Building and maintaining strong relationships with site staff and other stakeholders to facilitate smooth trial operations and support overall project success

What we offer

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

Senior Clinical Research Specialist

Imricor Medical Systems

Location:
United States , Burnsville

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 04, 2026

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