Sr CRA I (Ophthalmology)

• Candidate should have min 4 years of onsite monitoring experience
• Candidate should have ophthalmology therapeutic area experience
• immediate joiner preferred.
• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.  Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.  Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patients safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Per the Clinical Monitoring/Site Management Plan (CMP/SMP): o Assesses site processes o Conducts Source Document Review of appropriate site source documents and medical records o Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records o Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines

- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.

- Per the Clinical Monitoring/Site Management Plan (CMP/SMP):

- Assesses site processes

- Conducts Source Document Review of appropriate site source documents and medical records

- Verifies required clinical data entered in the case report form (CRF)is accurate and complete via review of site source documents and medical records

- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines

- Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture

- Verifies site compliance with electronic data capture requirements

• May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
• May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned.
• May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager.
• For Real World Late Phase (RWLP), the Sr. CRA I will use the businesscard title of Sr. Site Management Associate I. Additional responsibilities include:

- Site support throughout the study lifecycle from site identification through close out

- Knowledge of local requirements for real world late phase study designs

- Chart abstraction activities and data collection

- As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff

- Identify and communicate out of scope activities to Lead CRA/Project Manager

- Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations

- Identify operational efficiencies and process improvements

- Develop country level informed consent forms

- Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared

- Participate in bid defense meetings

Qualifications

- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience

- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

- Must demonstrate good computer skills and be able to embrace new technologies

- Excellent communication, presentation and interpersonal skills. Basic level of critical thinking skills expected.

- Ability to manage required travel of up to 75% on a regular basis