CRA – Central/Midwest

Planet Pharma; Illinois; Hybrid; USD 90,000 - 130,000; Full time

Job summary

Planet Pharma is seeking a Clinical Site Monitor to oversee site visits, ensure protocol compliance and data integrity across studies, and collaborate with investigators and sponsors.

You will lead monitor visits, train sites, manage submissions, and maintain essential TMF/ISF records while traveling up to 70% of the time in the US.

Qualifications

• On-site monitoring experience required; minimum 4 years.
• GCP and ICH knowledge and regulatory requirements proficiency.
• Experience with protocol knowledge and company training.
• Strong English communication skills, both written and verbal.
• Proficient with Microsoft Word, Excel and PowerPoint; use of laptop and mobile devices.
• Ability to travel approximately 70% of the time.

Responsibilities

• Perform site monitoring visits (initiation, monitoring, close-out) per contract scope and regulatory requirements.
• Collaborate with sites to recruit subjects per project needs to enhance predictability.
• Administer protocol training to sites and establish regular communication to manage expectations.
• Evaluate site practices for protocol conduct and regulatory compliance; escalate issues as needed.
• Track regulatory submissions, approvals, enrollment, CRF completion, data queries; may support start-up.
• Maintain TMF/ISF documents per GCP/ICH and local regulatory requirements.
• Document site management activities via visit reports and follow-up letters.
• Mentor clinical staff through co-monitoring and training visits.
• Coordinate with study team for project execution support.
• Possibly assist in developing recruitment plans and site finances per contract.

Skills

GCP & ICH knowledge

Regulatory compliance

Written and verbal English

Communication skills

Organizational skills

Problem-solving

Time management

Financial management

Relationship building

Travel readiness

Education

Bachelor's Degree in scientific discipline or health care

Equivalent combination of education, training and experience

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Laptop

iPhone/iPad

Job description

Job Overview

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator’s Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications

• Bachelor’s Degree Degree in scientific discipline or health care preferred. Req
• Requires at least 4 years of year of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Strong therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Ability to travel about 70% of the time