Clinical Research Associate, Sponsor Dedicated

Mass Digital Health; United States; On-site; USD 71,900 - 189,000; Full time

Job summary

Mass Digital Health is seeking a qualified candidate for a Monitoring position. The successful applicant will conduct monitoring visits and manage site data in accordance with regulations and sponsor requirements. Candidates should have a Bachelor's Degree in a scientific field and at least 2 years of site monitoring experience.

The role involves ensuring sites adhere to protocols, tracking study data, and collaborating closely with study teams. Strong communication and organizational skills are essential.

Qualifications

• 2 years of on‑site monitoring experience required.
• Strong command of English language in written and verbal forms.
• Ability to establish and maintain effective working relationships.

Responsibilities

• Perform monitoring and site management work.
• Conduct site monitoring visits in accordance with Good Clinical Practice.
• Manage the progress of assigned studies and track submissions.

Skills

Clinical research regulatory requirements knowledge

Site monitoring experience

Verbal communication skills

Organizational skills

Problem-solving skills

Proficiency in Microsoft Word

Proficiency in Microsoft Excel

Proficiency in Microsoft PowerPoint

Education

Bachelor's Degree in a scientific discipline or health care

Tools

Laptop computer

iPhone

iPad

Job description

Eligibility

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

Responsibilities

• 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.
• 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 a 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 including 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.

EEO Statement

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

Compensation and Benefits

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.