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Cra Project Manager Jobs in Wyoming (NOW HIRING)

Alira Health

Clinical Research Associate

Bordeaux, WY · On-site

CRAs work closely with the In-house CRAs, Lead CRAs, Director of Clinical Monitoring and Project Managers to ensure sites' protocol compliance, address site questions, and assist with study ...

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Cra Project Manager information

What is a CRA Project Manager?

A CRA Project Manager is a professional who oversees and coordinates clinical research projects, often within pharmaceutical or biotechnology companies or contract research organizations (CROs). They are responsible for planning, executing, and closing clinical trials in compliance with regulatory guidelines. Their duties include managing budgets, timelines, and resources, communicating with stakeholders, and ensuring the quality and integrity of the research data. CRA Project Managers also supervise clinical research associates (CRAs) and ensure that all trial activities adhere to protocols and Good Clinical Practice (GCP) standards.

What are the key skills and qualifications needed to thrive as a CRA Project Manager?

To thrive as a CRA Project Manager, you need a solid background in clinical research, project management expertise, and typically a degree in life sciences or a related field. Familiarity with clinical trial management systems (CTMS), regulatory compliance (such as GCP), and often a project management certification like PMP are highly beneficial. Strong leadership, problem-solving, and communication skills set exceptional candidates apart, especially when managing diverse teams and stakeholders. These skills ensure successful project delivery, regulatory adherence, and effective coordination of clinical research activities.

What are some common challenges faced by a CRA Project Manager when coordinating multi-site clinical trials?

CRA Project Managers often encounter challenges such as ensuring consistent communication across diverse research sites, maintaining regulatory compliance, and managing tight project timelines. They must address site-specific issues quickly while balancing the needs of sponsors, investigators, and regulatory bodies. Success in this role requires strong organizational skills, adaptability, and a proactive approach to problem-solving, as well as the ability to foster collaboration among cross-functional teams.

What is the difference between Cra Project Manager vs Clinical Research Associate?

AspectCra Project ManagerClinical Research Associate
CredentialsBachelor's degree, often advanced degrees, project management certificationsBachelor's degree in life sciences or related field, clinical research certifications
Work EnvironmentOversees multiple projects, manages teams, coordinates with sponsorsMonitors clinical trials at sites, ensures protocol compliance
Employer & Industry UsagePharmaceutical companies, CROs, biotech firmsPharmaceutical companies, CROs, clinical trial sites

The Cra Project Manager focuses on overseeing entire clinical projects, managing teams, and ensuring timely delivery. In contrast, a Clinical Research Associate primarily monitors clinical trial sites to ensure compliance with protocols. Both roles require related certifications and work within the clinical research industry, but their responsibilities and scope differ significantly.

Cra Project Manager jobs near you

Clinical Research Associate

Bordeaux, WY • On-site

Alira Health
Pharmaceutical and Medicine Manufacturing • 51 - 200 employees
Learn more about Alira Healthexternal

Full-time

Re-posted 9 days ago

Key responsibilities

  • Conduct site monitoring visits, including qualification, initiation, interim, and close-out visits, and document these visits properly.

  • Prepare monitoring visit reports that detail site-related issues, resolutions, protocol deviations, study progress, and enrollment status.

  • Ensure data integrity by reviewing source documents, reconciling adverse event reports, and verifying case report forms (CRFs).

Job description

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

Job Description

ROLE

The Clinical Research Associate is an important member of the Alira Health Clinical team. CRAs are highly motivated and function independently to conduct site monitoring responsibilities for clinical trials. CRAs work closely with the In-house CRAs, Lead CRAs, Director of Clinical Monitoring and Project Managers to ensure sites' protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.

KEY RESPONSABILITIES

  • Performs qualification, initiation, interim, and close-out visits and ensures proper documentation of site visits.

  • Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.

  • Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs.

  • Ensures integrity of CRF data through meticulous and thorough source document review and verification.

  • Conducts investigational product accountability.

  • Reviews regulatory binder for required documents.

  • Works closely with in-house CRAs and data management to resolve queries on discrepant data.

  • Proactively identifies site issues and develops problem-solving strategies for sites.

  • Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests.

  • Conducts audit preparation at study sites as needed.

  • Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.

  • Manages and resolves conflicting priorities to deliver on commitments.

  • Complies with ICH GCP guidelines, FDA regulations, and company SOPs.

  • Participates in industry and client meetings.

  • Performs additional duties as assigned.

DESIRED QUALIFICATION & EXPERIENCE

  • BS/BA from an undergraduate program or equivalent experience

  • 2 years of clinical research experience

TECHNICAL COMPETENCES & SOFT SKILLS

  • Ability to travel.

  • Proven ability to be careful, thorough, and detail-oriented.

  • Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment.

  • Self-starter who thrives in a collaborative, yet less structured team environment

  • Ability to problem-solve unstructured or ambiguous challenges.

  • Strong command of English, both written and verbal.

  • Excellent communication and interpersonal skills with customer service orientation.

  • Proficient with MS Office Suite, particularly Word and Excel.

  • Permanent authorization to work in the country where you are applying.

Languages

English

Education

Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences

Contract Type

Regular

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