Clinical Research Associate, Sponsor Dedicated

IQVIA; Belmar (NJ); On-site; USD 71,900 - 189,000; Full time

Job summary

IQVIA in Belmar, New Jersey, is seeking a Clinical Research Site Manager to perform monitoring and site management for clinical studies. The role requires at least 2 years of on-site monitoring experience and a Bachelor's Degree in a scientific discipline or healthcare. Responsibilities include site monitoring visits, evaluating study practices, and managing regulatory submissions. Potential base pay ranges from $71,900 to $189,000, with additional benefits offered.

Qualifications

• At least 2 years of on-site monitoring experience is required.
• Good therapeutic and protocol knowledge as provided in company training.
• Ability to adapt to project needs and enhance predictability.

Responsibilities

• Perform site monitoring visits in accordance with contracted scope of work.
• Manage regulatory submissions and approvals for assigned studies.
• Evaluate the quality and integrity of study site practices.

Skills

Good Clinical Practice (GCP)

Clinical research regulatory requirements

Proficiency in Microsoft Word, Excel, and PowerPoint

Written and verbal communication skills

Organizational skills

Problem-solving skills

Effective time management skills

Ability to maintain effective working relationships

Education

Bachelor's Degree in scientific discipline or health care

Tools

Laptop

iPhone

iPad

Job description

To be eligible for this position, you must reside in the same country where the job is located.

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 Good Clinical Practice.
• 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 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.
• 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 in scientific discipline or health care preferred.
• Requires at least 2 years of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
• i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Good 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.