Senior Clinical Research Associate

4-9 years

$55.25/hr - $67.25/hr

Remote, USA

10 Aug. 16, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Clinical Research Associate, Phase 1 Oncology

Employment Type: Direct Hire, Full-Time

Salary Range: $115,000 - $140,000 per year

Location: Remote (Eastern Standard Time) – Requires up to 65% travel

Job Summary:

As a Senior Clinical Research Associate specializing in Phase 1 Oncology, you will play a pivotal role in overseeing and managing clinical trials. Your responsibilities will include ensuring that trials are conducted, documented, and reported in compliance with protocols, standard operating procedures (SOPs), ICH GCP guidelines, and all relevant regulatory requirements. This role may require up to 65% travel.

Key Responsibilities:

Clinical Study Monitoring: Conduct qualification, initiation, interim, and close-out site visits for clinical studies involving investigational and approved products that meet medical needs and offer commercial benefits.
Site Management: Train and oversee site personnel in therapeutic areas, protocol adherence, source documentation, and case report form completion.
Investigational Supply Management: Oversee the preparation and return of investigational supplies at individual sites.
Product and Sample Monitoring: Monitor and document the dispensing, inventory, and reconciliation of investigational products, as well as the storage and shipment of laboratory samples.
Trial Oversight: Review and report on site enrollment and termination, monitoring visits, protocol deviations, serious adverse events, and laboratory abnormalities.
Data Integrity: Ensure the accuracy, completeness, and integrity of source data and case report forms by identifying and resolving data issues.
Regulatory Support: Assist study centers with regulatory documentation and address any regulatory issues.
Study File Maintenance: Maintain complete and accurate study files, ensuring all necessary documentation is in place.
Communication: Maintain regular and timely communication with study centers, investigators, coordinators, client personnel, and other stakeholders.
Team Support: Act as a resource for project team members, offering guidance and solutions to support CRA I and CRA II staff in resolving issues.

Requirements and Qualifications:

Experience: Proven experience in Phase 1 Oncology trials.
Education: RN, Bachelor's degree, or an advanced degree in biological sciences or a related field, or an equivalent combination of relevant experience, education, and training.
Skills: Detail-oriented with excellent organizational, interpersonal, communication, and problem-solving skills.
Flexibility: Ability to adapt to changing priorities and efficiently manage multiple tasks.
Industry Knowledge: Familiarity with medical and pharmaceutical industries, including FDA regulations and their practical application.
Travel: Willingness and ability to travel, including by air or car, on short notice.
Technical Proficiency: Proficient in Microsoft Word, Excel, and PowerPoint.

Desired Skills and Experience:

Clinical Research Associate (CRA) experience in Phase 1 Oncology.
Knowledge of FDA regulations.
Proficiency in Microsoft Office.

Note: Bayside Solutions, Inc. may collect your personal information during the application process. For more details, please refer to Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.

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Senior Clinical Research Associate

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