Senior Clinical Research Associate - Remote, United States - PSI

PSI Remote, United States

1 day ago

Description

Company Description

PSI is a leading Contract Research Organization (CRO) with more than 25 years of experience in the pharmaceutical industry.

PSI is a privately-owned, full-service globally operating CRO.

PSI's global reach supports clinical trials across multiple countries and continents and we are known to be highly selective about the work we pursue.

We focus on delivering quality and on-time services across a variety of therapeutic indications.

With an exceptionally high repeat and referral business rate combined with minimal staff turnover, PSI is committed to being the best CRO in the world as measured by its customers, employees, sites, and vendors.

Job Description

As a Senior CRA (Radiopharmaceuticals) you will participate in the preparation and execution of Phase I-IV oncology clinical trials with particular focus on radiopharmaceutical studies including startup and site monitoring activities to ensure timelines and deliverables are met at assigned sites.

You will build and maintain strong relationships with clinical sites and investigators and assess protocol and regulatory compliance in accordance with applicable local and federal regulatory requirements, ICH GCP and PSI SOPs.

You will focus on subjects' rights, safety and well-being and ensure a high quality of data.

Responsibilities include:

Prepare, conduct and report on activities related to the completion of site selection, initiation, routine monitoring and close-out visits
Monitor patient enrollment to ensure recruitment targets and project timelines are met at the site and/or country level
Perform source data verification and follow up on data queries at the site level, on-going review of any Risk Based Monitoring related information influencing data quality and frequency of site visits
Ensure accurate and timely reporting and follow up of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations
Act as the main line of communication between the Sponsor and the site
Be a point of contact/liaison for in-house support services and vendors
Ensure proper handling, accountability and reconciliation of all Investigational Product(s) and clinical study supplies
Review the status and contents of essential documents at the site level and reconcile study OSF/ TMF at site and/or country level

Qualifications

Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience.
Minimum of 3 years' site monitoring experience.
Prior experience in Radiopharmaceuticals is required.
Strong experience in Oncology required.
Experience with all types of monitoring visits in Phase II and/or III.
Full working proficiency in English.
Proficiency in MS Office applications.
Ability to plan, multitask and work in a dynamic team environment.
Excellent Communication, collaboration, and problem-solving skills.
Ability to travel up to 65% (depending on project needs).
Valid driver's license (if applicable).

Additional Information

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

Clinical Research Associate II

1 day ago

PSI Remote, United States

Company Description · PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therap ...
Lead Clinical Research Associate

2 weeks ago

PSI Remote, United States

Company Description · PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therap ...
Pre-Registration Specialist

1 day ago

MultiCare Health System Remote, United States

You Belong Here. · At MultiCare, we strive to offer a true sense of belonging for all our employees. Across our health care network, you will find a dynamic range of meaningful careers, opportunities for growth, safe workplaces, and flexible schedules. We are connected by our mis ...
Clinical Informatics Specialist Sr

1 day ago

MultiCare Health System Remote, United States

You Belong Here. · At MultiCare, we strive to offer a true sense of belonging for all our employees. Across our health care network, you will find a dynamic range of meaningful careers, opportunities for growth, safe workplaces, and flexible schedules. We are connected by our mis ...
Provider Compensation Partner

1 week ago

MultiCare Health System Remote, United States

You Belong Here. · At MultiCare, we strive to offer a true sense of belonging for all our employees. Across our health care network, you will find a dynamic range of meaningful careers, opportunities for growth, safe workplaces, and flexible schedules. We are connected by our mis ...
Referral Coordinator NRU

1 day ago

MultiCare Health System Remote, United States

You Belong Here. · At MultiCare, we strive to offer a true sense of belonging for all our employees. Across our health care network, you will find a dynamic range of meaningful careers, opportunities for growth, safe workplaces, and flexible schedules. We are connected by our mis ...
Revenue Integrity Ops Advisor

1 day ago

MultiCare Health System Remote, United States

You Belong Here. · At MultiCare, we strive to offer a true sense of belonging for all our employees. Across our health care network, you will find a dynamic range of meaningful careers, opportunities for growth, safe workplaces, and flexible schedules. We are connected by our mis ...
Pre Registration Specialist

1 day ago

MultiCare Health System Remote, United States

You Belong Here. · At MultiCare, we strive to offer a true sense of belonging for all our employees. Across our health care network, you will find a dynamic range of meaningful careers, opportunities for growth, safe workplaces, and flexible schedules. We are connected by our mis ...
Utilization Management Specialist RN

4 days ago

MultiCare Health System Remote, OR, United States

You Belong Here. · At MultiCare, we strive to offer a true sense of belonging for all our employees. Across our health care network, you will find a dynamic range of meaningful careers, opportunities for growth, safe workplaces, and flexible schedules. We are connected by our mis ...
Part Time Local News Associate Producer

3 weeks ago

Hearst Television Remote, United States Full time

Local News Associate Producer (Entry Level) · WMUR-TV, the ABC affiliate in Manchester, NH has a part-time opening for an Associate Producer. You will assist producers in all aspects of producing a newscast. This will include writing stories, creating graphics, researching inform ...
Associate Product Manager

1 day ago

Vitera Healthcare Solutions Remote, United States

You Belong at Greenway · Bring your best and truest self. We celebrate what makes us different and what brings us all together. At Greenway Health, we are committed to an inclusive environment and a culture of belonging as we pursue our purpose of healthier communities, successfu ...
Supv Referral Management

2 weeks ago

MultiCare Health System Remote, United States

You Belong Here. · At MultiCare, we strive to offer a true sense of belonging for all our employees. Across our health care network, you will find a dynamic range of meaningful careers, opportunities for growth, safe workplaces, and flexible schedules. We are connected by our mis ...
Supv Referral Management

2 weeks ago

MultiCare Health System Remote, United States

You Belong Here. · At MultiCare, we strive to offer a true sense of belonging for all our employees. Across our health care network, you will find a dynamic range of meaningful careers, opportunities for growth, safe workplaces, and flexible schedules. We are connected by our mis ...
client service associate

2 weeks ago

Cotiviti Remote, OR, United States

The Client Service Associate's (CSA) role is to ensure adequate support for the client-facing team on coding and policy-related activities. The CSA must be familiar with the day-to-day activities of the Client Policy Manager (CPM), Client Service Manager (CSM), and client-facing ...
Clinical Research Coordinator/Analyst

1 week ago

Headlands Research Remote, United States

Overview · At Headlands Research, we are building a best in class clinical trial network. We're an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding participant engagement ...
Corporate Counsel

1 day ago

Intoxalock Remote, United States

Consumer Safety Technology (CST) and our family of brands have helped millions of individuals to live and drive responsibly. Intoxalock, a subsidiary of CST, is the country's largest ignition interlock provider (IIDs) in the United States and the only company working to assist in ...
Employee Wellness Partner

5 days ago

MultiCare Health System Remote, OR, United States

You Belong Here. · At MultiCare, we strive to offer a true sense of belonging for all our employees. Across our health care network, you will find a dynamic range of meaningful careers, opportunities for growth, safe workplaces, and flexible schedules. We are connected by our mis ...
Health & Life Sciences Leader

1 day ago

MBP Remote, United States

Overview · EXPERIENCE QUALIFICATION: · Experienced Business Development professional with proven experience developing client relationships and identifying new business opportunities in the healthcare and life sciences sector. · Responsibilities · MAIN DUTIES · * Primary duty is ...
Senior Engineer

1 week ago

Haskell Remote, United States

Overview · Are you ready to move your career forward, and start the BEST job of your life? Haskell is committed to providing you with the resources to help you grow and discover your potential. We promote an environment that encourages innovative ideas and allows you to develop t ...
Inpatient Audit Specialist

1 week ago

CIOX Remote, United States

Overview · Who we are... · Ciox Health merged with Datavant in 2021, creating the nation's largest health data ecosystems, powering secure data connectivity on behalf of thousands of providers, payers, health data analytics companies, patient-facing applications, government agenc ...