Piper Companies logo
Piper Companies

Piper Companies is a niche staffing and consulting agency that specializes in talent placement for the information technology field. Its two main divisions are Piper Clinical Solut

Senior Clinical Research Associate - Oncology

Location

Michigan

Posted

10 days ago

Salary

$120K - $150K / year

Seniority

Senior

Bachelor Degree

Job Description

Senior Clinical Research Associate - Oncology

Piper Companies

Title: Senior Clinical Research Associate - Oncology Location: Lansing United States Job Id: 166232 Job Category: Security Clearance: No Clearance Business Unit: Piper Companies Division: Piper Clinical Solutions Position Owner: Bailey Horne Job Description: Piper Companies is seeking a well-rounded Senior Clinical Research Associate with direct oncology monitoring experience to work with a Global CRO. The Clinical Research Associate will be working remote with some travel included. Requirements for the Senior Clinical Research 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 Senior Clinical Research Associate include: · 3+ years of Oncology monitoring experience · 3+ 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 Senior Clinical Research Associate includes: · Salary range: $120,000 - $150,000 · Comprehensive benefit package: Medical, Dental, Vision, 401k match plus PTO, Sick leave as required by law, and Paid Holidays Keywords: Clinical research 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

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Child Welfare Investigator

State of Arizona

The State of Arizona, otherwise known as "The Grand Canyon State," is one of the "Four Corner States" in the U.S. Home to some of the nation's most popular tourist attractions, suc

Research Analyst10 days ago

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Clinical Research Associate

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A full-service clinical research organization (CRO) founded in 1992, Medpace is headquartered in Cincinnati, Ohio, and has office locations spanning six contine

Research Analyst11 days ago

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Australia
Full TimeRemoteTeam 10,001+Since 2013H1B Sponsor

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Massachusetts
$84.5K - $162K / year
Job Closed
Full TimeRemoteTeam 10,001+Since 1983H1B Sponsor

• Perform site management activities to ensure compliance with the protocol, monitoring plan, ICH GCP, local regulatory requirements, and client SOPs • Conduct site qualification, initiation, interim, and close-out visits, both on-site and remotely • Partner with Clinical Trial Liaison (CTL) and other client functions (e.g., Study Start-Up, Global Partnerships and Trial Optimization) to support site activation and deliverables • Establish and maintain productive professional relationships with investigator site staff, ensuring effective communication and problem-solving throughout study conduct • Perform drug accountability, reconciliation, and destruction, ensuring protocol compliance for storage and shipment requirements • Prepare and maintain Oversight Monitoring Plan • Perform review of study metrics, assess CRO Clinical Research Associate (CRA) and Investigator Site performance and identify sites for oversight monitoring visits • Conduct Oversight Monitoring Visits at sites, either independently or alongside CRO CRA • Review site source documentation and verify accurate data capture (ALCOA principles) • Review and report on status of study conduct at the investigator site ensuring appropriate follow up of any identified issues/action items • Ensure site regulatory files are current and verify timely submission of study documentation, including safety reporting • Write and submit accurate monitoring visit reports, oversight monitoring visit reports, and study correspondence in a timely manner • Periodically verify completeness of site documentation (e.g., investigator site file/regulatory binder contents) • Identify and record protocol deviations, escalate non-compliance, and resolve study-related issues as necessary • Track, trend, and report issues, escalating them to the appropriate teams when required • Maintain ongoing communication with site personnel, study teams, CTLs, Central Monitors, and CRO CRAs • Actively participate in team meetings and process improvement initiatives to enhance study outcomes • Support inspection readiness activities and ensure sites maintain data integrity and protocol deliverables

Florida