Clinical Study Coordinator Job at Solomon Page (Hendersonville)

Clinical Research Coordinator

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

Location

United States , Boston

Salary:

44657.60 - 69773.60 USD / Year

Boston Children's Hospital

Expiration Date

Until further notice

Requirements

A Bachelor’s Degree is required
2 years of relevant experience is required

Job Responsibility

Working with Principal Investigators (PIs) to facilitate and coordinate the everyday activities of assigned clinical trials including scheduling patient visits with many different departments e.g. Physical Therapy, Radiology, and Anesthesia
Attending and organizing all study visits with the participant and family
Monitoring for Adverse Events with study participants, and reporting them to the PI, IRB and sponsor in a timely manner
Facilitating communication between the PI and the patients
Maintaining study protocol documents for applications or amendments to the IRB
Ensuring that all staff involved in the study have been trained properly
Coordinating with study sponsors and monitors to ensure compliance with the protocol and reporting protocol deviations
Maintenance of regulatory binders, Case Report Forms, Visit Order forms and other study related documentation. Ensuring patients are reimbursed for their visits
Recruiting, screening and consenting patients to studies
Data entry and resolution to data entry queries

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 Coordinator

The Computational Health Informatics Program (CHIP) is seeking an experienced, h...

Location

United States , Boston

Salary:

58676.80 - 93901.60 USD / Year

Boston Children's Hospital

Expiration Date

Until further notice

Requirements

Bachelor’s degree
Master’s preferred
Bachelor’s degree and 4 years of relevant work experience OR Master’s degree and 2 years of relevant work experience
Analytical skills to gather and interpret data in which the information or problems are moderately complex to complex
Well-developed communication skills to provide critical information to patients, effectively deal with conflicting views or issues, and the ability to mediate fair solutions
Ability to effectively engage with and influence others
build working relationships and can work independently and as a team member, leads others when needed
Act as a resource and must be knowledgeable and compliant in all hospital, State, and Federal regulatory requirements, including hospital policy and procedures

Job Responsibility

In conjunction with the Principal Investigator and/or designees designs, develops, and implement clinical research projects such as enrollment strategies, study materials, and study documents
Responsible for daily operations of the study
Develops and implements processes and procedures to meet study goals and protocol requirements
Participate in training and prepare study related training materials
Plans and prioritizes the work of administrative and support personnel on all clinical study activities
Consents and enrolls patients for research studies by providing detailed information on the Clinical Study to patients and families
Communicates all policies and procedures and responds to all inquiries
Evaluate the suitability of prospective study candidates and make selections based on clinical knowledge of each study
Provide input for updates of SOPs and drafting of new quality documentation
Assist with developing and implementing best practice guidelines for conducting various clinical research protocols

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

Clinical Research Study Coordinator

This is an exciting opportunity to join EMS Healthcare as a Clinical Research St...

Location

United Kingdom , West Kirby

Salary:

Not provided

EMS Healthcare

Expiration Date

Until further notice

Requirements

Experience coordinating or supporting clinical research studies in an NHS, academic, or commercial setting
Understanding of ICH-GCP and regulatory frameworks governing clinical trials
Demonstrated ability to manage participant interactions and study workflows
Strong organisational skills with the ability to manage competing priorities
Confident using electronic data capture systems or clinical databases
Full UK residency and right to work
Valid UK driving licence and willingness to travel across Greater Manchester and EMS sites as needed
Flexibility to work early mornings, evenings, or weekends depending on study needs

Job Responsibility

Coordinate day-to-day operational aspects of assigned clinical studies, ensuring alignment with protocols, GCP, and EMS SOPs
Schedule and manage participant visits, including screening, enrolment, and follow-up activities
Maintain detailed, accurate study documentation, including source data, CRFs, logs, and regulatory binders
Collaborate with clinical staff, including nurses and investigators, to ensure study timelines and objectives are met
Support participant retention and compliance through effective communication and follow-up
Assist in the setup and maintenance of study equipment, supplies, and site readiness
Liaise with the data management team to ensure timely entry, verification, and query resolution
Participate in site meetings, staff training, monitoring visits, and audits as required
Ensure participant safety, confidentiality, and adherence to ethical and regulatory standards
Contribute to continuous improvement and operational excellence across the EMS Study portfolio

What we offer

Bank holidays, plus 25 days annual leave, increasing to 28 after 5 years
Buy & Sell Holidays
Enhanced Maternity and Paternity Leave
1 Occasion Day each year
Healthshield
Cycle to Work Scheme
Tech Scheme
Electric Car Scheme
Subsidised company events and gatherings
A gift for your birthday

Fulltime

Clinical Research Coordinator II-OB/GYN

Under minimal supervision, coordinates the clinical assessments of the study sub...

Location

United States , New York

Salary:

63653.84 - 85000.06 USD / Year

Mount Sinai Health System

Expiration Date

Until further notice

Requirements

Bachelors degree in sciences or related field
2 years of clinical research

Job Responsibility

Analyzes moderately complex clinical research data
Assists in interpreting clinical research data
Coordinates the clinical assessments of the study subjects including but not limited to screening and evaluation of the study subjects
Prepares and ensures grant applications, IRB/GCO documents are submitted
Ensures accurate and complete compilation of subject data through chart reviews
Assists the Principal Investigator and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials
Obtains informed consent under supervision of the Principal Investigator, Clinical Research Manager, or Senior Clinical Research Coordinator for studies enrolling vulnerable subjects, and for studies involving genetic tests
Independently obtains informed consent for other clinical studies
Mentors Clinical Research Coordinators in training
Performs other related duties

Clinical Monitoring Manager

We are seeking a Clinical Monitoring Manager to oversee in-house Oversight CRAs ...

Location

United States

Salary:

150000.00 - 170000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or healthcare-related field
Minimum of 8 years of experience as a CRA or related role within the pharmaceutical, biotechnology, or medical device industry
Minimum 2 years of experience leading a team of CRAs
Recent experience working on respiratory, dermatology and / or gastrointestinal clinical trials a plus
Certification as a Clinical Research Associate (CCRA) or equivalent preferred
Recent experience working on trials utilizing risk-based monitoring models
Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP), and FDA regulations
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet
Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems
Strong understanding of clinical trial processes and study conduct

Job Responsibility

Oversee in-house Oversight CRAs that will oversee CRO CRA’s management of clinical study site activities for Apogee sponsored clinical trials
Serve as Apogee’s primary liaison with the in-house CRAs and CRO clinical monitoring team and liaise with clinical study sites
Accountable for oversight of clinical monitoring activities from site identification through close out of the study site
Responsible for the study deliverables of in-house CRAs on a given study(s)
May be responsible for the hiring of in-house CRAs
Input into and assist with the development of study documents
Oversee development and implementation of project specific processes, tools, and documents
Support the training and development of in-house CRAs
Oversight of review of monitoring visit reports and metrics
Responsible for oversight of CRA review of clinical data

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
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

Fulltime

Manager, CSAR - Global Library

The Global Library Manager will report to the Sr. Manager, Clinical System and A...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree in life science, computer science, business administration or related field and 4 to 6 years of experience
Bachelor’s degree in life science, computer science, business administration or related field and 6 to 8 years of experience
Diploma in life science, computer science, business administration or related field and 10 to 12 years of experience
Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena
General project management and planning experience
Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.)
Good Clinical Practice knowledge
Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking
Knowledge of drug development and clinical trials processes
Knowledge of data management processes

Job Responsibility

Support of clinical trial platform technologies
Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight
Leading and / or coordinating the definition of studies in clinical trial databases or clinical systems
Coordinating and providing programming support to Clinical Study Teams
Maintaining standard business processes within GDO to ensure compliance to regulatory bodies
Acting as a technical point of contact for systems deliverables on defined programs
Providing technical and business process input / expertise on new and emerging technologies
Develop, review and implement policies, SOPs and associated documents
Assist in preparing for and responding to audit findings (internal or external)
Provide Global Library review at the study level

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards