Senior Contract Clinical Research Associate Iii

**Summary of the Position**:
The Senior Contract Clinical Research Associate III (Snr. CRA III) 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.
- 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.
- 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.
- Proven Oncology clinical trials monitoring experience

**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