Summary of the Position:
The Senior Clinical Research Associate II (Snr. CRA II) monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), study protocols and applicable regulatory requirements. Reviews study documents as required and prepares site visit reports. Maybe responsible for multiple projects and must work both independently and in a team environment. Participate in the study development and start-up process including reviewing protocols, designing and/or reviewing Case Report Forms (CRF), preparing Informed Consent Forms (ICF's), developing study documents, organizing, and presenting at investigator meetings, working with management on a monitoring strategy, and/or developing project specific CRA training. They may participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. They may provide a benchmark of monitoring competence to inexperienced/less experienced colleagues. Prepares clinical documents, business correspondence, and procedural manuals. Maintain systems and processes necessary to report trial status and activities; and to help ensure that quality, regulatory-compliant clinical projects are conducted on time and within budget.
Depending upon the level of experience, may become involved in other areas of study management and staff training. Contributes to the review of sponsor/client's and/or FHI Clinical's systems and procedures as appropriate.
Essential Functions:
Contributes to the development of routine protocols, informed consent/assent forms, SOPs, and other appropriate study documentation.
Monitors clinical trials to ensure subject safety and compliance with the study protocol, applicable regulations and ICH GCP Guidelines.
Performs site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work, SOPs, and regulatory requirements, i.e., Good Clinical Practice (GCP) and other International Council on Harmonization (ICH) guidelines.
Ensures timely submission of protocols, informed consents, safety report reports and other regulatory documents for IRBs/IEC approval according to local requirements.
Works with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
Administers protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluates 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.
Manages 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.
Ensures copies of 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 ICH GCP and local regulatory requirements.
Creates and maintains 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 within expected timelines in accordance with SOPs and study plans.
Provides guidance on any protocol-related issues.
Manages budget to ensure CRA activities are completed as per contract.
Develops, reviews, and maintains key study documents to ensure adequate resource and reference documentation.
May serve as a liaison with internal and external partners to ensure effective collaboration efforts.
Provides input with CRF development, analysis, study design, and material management.
Updates and maintains study specific tracking tools.
May function as project manager or clinical trial manager on assigned projects taking on a lead role of achieving specific milestone goals to completion.
Responsible for ensuring that data will pass international quality assurance audits.
Represents FHI Clinical in the global clinical research community and develops and maintains collaborative relationships with investigational sites and clients.
May review and approve the work and written reports of team members.
Knowledge, Skills, and Abilities:
Proven clinical monitoring skills.
Development and preparation of applicable study tools and documents.
Demonstrates effective management skills to prioritize and organize work and mentor junior staff members.
Demonstrates project management capabilities including planning, tracking of milestones/deliverables, and monitoring of resources and budget requirements.
Problem Solving and Impact:
Works on complex problems that require analysis or interpretation of various factors.
Exercises independent judgment in determining methods and techniques to accomplish results.
Decisions could have a major impact on management and operations of an area within the department.
Determines and develops plans and procedures on new assignments and may direct the work of others.
Position Requirements:
Education: Bachelor's or higher degree (or its international equivalent) in a medical/science-related field is preferred. In lieu of a degree, an equivalent combination of diplomas or certification and relevant work experience is required. Licensed or certified health care training will be beneficial.
Preferred Job-related Experience: Adequate experience as a CRA performing on-site monitoring on complex studies, or equivalent experience is required. Preferably at least 5 years as a CRA, showing a high level of competency and demonstrating attributes to meet additional responsibilities as a Senior CRA is preferred. A proven track record of excellence in terms of quality and delivery will be beneficial.
Additional Eligibility Qualifications:
Thorough knowledge of ICH GCP, local legal requirements and relevant FDA, EMA and other international guidelines as well as the Company's Directives.
In-depth knowledge and understanding of theory and practice of monitoring.
Advanced knowledge of medical, logistical, and political aspects of at least one therapeutic area.
Ability to assess knowledge gaps in peers and to find appropriate opportunities to enable colleagues to gain the required experience.
Able to determine the most appropriate methods and procedures when given a new assignment and able to take a leadership role in implementing the monitoring aspect of a clinical trial.
Able to review reports, regulatory documents and other trial-related documentation to ensure documents meet required standards.
Proficient in Microsoft Office (i.e., Word, Excel, PowerPoint, Outlook, SharePoint, Teams, etc.), virtual communication platforms and other technology required.
Articulate, professional and able to communicate in a clear, positive fashion with clients and staff.
Must be able to read, write and speak fluent English.
Special Position Requirements:
Valid passport.
Availability to travel.
For Snr. CRA II's based in South Africa, or other countries, where applicable, a valid driver's license is required.
Physical Expectations:
Typical office environment.
Ability to sit or stand for extended periods of time.
Ability to move 5-15 lbs.; or 2.26 - 6.8 kg.
Travel Requirements:
Expected travel time is greater than 50% for this position.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.
FHI Clinical, Inc. and its subsidiary and affiliate companies provide equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.
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