Summary of the Position:
The Clinical Research Associate II (CRA II) manages clinical study sites and monitors site activities to assure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), study protocols, and applicable regulatory requirements.
Reviews regulatory documents as required and prepares site visit reports. May be 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 consents, SOPs, and other appropriate documentation.
Monitors clinical trials to ensure subject safety and compliance with the study protocol, FDA and/or other regulations, and ICH GCP Guidelines. Ensures timely submission of protocols, informed consents, safety report reports and other regulatory documents for IRBs/IEC approval according to local requirements.
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.
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 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.
Collaborates with study team members for project execution support as appropriate.
Manages budget for task assigned are completed as per expectation.
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.
Ensures compliance with government regulations when /if contributing to protocols, analysis plans, reports, and manuscripts.
Provides input with questionnaire development, analysis, study design, and material management.
Knowledge, Skills, and Abilities:
Demonstrated understanding of, and skill in applying, applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and other International Council on Harmonization (ICH) guidelines.
Good knowledge of concepts, practices, and procedures for conducting clinical research studies.
Computer skills, including proficiency in the use of Microsoft Word, Excel and PowerPoint and use of a laptop computer (where applicable).
Written and verbal communication skills including good command of English language.
Organizational and problem-solving skills.
Effective time and financial management skills.
Exceptional attention to detail.
Ability to establish and maintain effective working relationships with coworkers, managers, site staff and clients.
Solid knowledge of software programs used to collect data and track risk-based monitoring parameters.
Ability to analyze and interpret data, identify errors, and prepare reports.
Effective clinical monitoring skills, including remote monitoring.
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
Proven flexibility and adaptability.
Ability to work in a team or independently as required.
Position Requirements:
Education: Bachelor's or higher graduate 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 I, performing administrative and on-site monitoring on a variety of studies, or equivalent experience is required. At least 1 or more years as a CRA I or equivalent position is preferred.
Additional Eligibility Qualifications: Must be proficient in Microsoft Office, virtual communication platforms and other technology required. Articulate, professional, and able to communicate in a clear, positive fashion with clients and staff.
Special Position Requirements: Valid passport. Availability to travel. For CRA II's based in South Africa, and 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 2.6 - 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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