Description
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.
Responsibilities:
- Conduct site monitoring visits in accordance with contracted scope of work and regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Collaborate with sites to adapt, drive, and track subject recruitment plans in line with project needs
- Provide protocol and related study training to assigned sites and establish regular lines of communication 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
- Manage study progress by tracking regulatory submissions and approvals, recruitment and enrollment, case report form completion and submission, and data query generation and resolution
- Ensure 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 documentation regarding site management, monitoring visit findings, and action plans
- Collaborate with study team members for project execution support as needed
Qualifications:
- Minimum of 1 year of independent on-site monitoring experience as a Clinical Research Associate (CRA)
- Bachelor's Degree in a scientific discipline or healthcare preferred
- 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 GCP and ICH guidelines
- Good therapeutic and protocol knowledge as provided in company training
- Proficiency in Microsoft Word, Excel, and PowerPoint, and use of a laptop computer and iPhone and iPad (where applicable)
- Excellent written and verbal communication skills, including good command of English language
- Strong organizational and problem-solving skills
- Effective time and financial management skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
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.