CRA – East Coast

Planet Pharma; New Jersey; Hybrid; USD 110,000 - 150,000; Full time

Job summary

Planet Pharma is seeking an experienced Clinical Site Monitor to ensure sites conduct studies per protocol, GCP/ICH, and sponsor requirements. You will manage site visits, training, and communications with study sites in a fast-paced environment.

The role requires 4+ years of on-site monitoring, strong regulatory knowledge, and the ability to travel up to 70% to support multiple sites and TMF maintenance. Bachelor's degree in a scientific discipline or health care is preferred.

Qualifications

• Bachelor’s degree in scientific discipline or health care preferred.
• Requires at least 4 years of on-site monitoring experience.
• In-depth knowledge of GCP/ICH regulatory requirements.
• Proficient in Microsoft Word, Excel and PowerPoint.
• Written and verbal communication skills including good command of English.
• Organizational and problem-solving skills.
• Ability to travel about 70% of the time.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements (GCP/ICH).
• Drive and track subject recruitment plan to enhance predictability.
• Administer protocol and related study training to assigned sites and maintain regular communication.
• Evaluate site practices for protocol conduct and regulatory adherence; escalate quality issues as needed.
• Track regulatory submissions and approvals, recruitment/enrollment, CRF completion and data queries; support start-up as needed.
• Maintain Trial Master File and Investigator’s Site File per regulatory requirements.
• Create and maintain documentation of site management, monitoring findings and action plans.

Education

Bachelor’s Degree in scientific discipline or health care

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