The Snr. Clinical Research Associate maintains Trial Master File (eTMF) and is responsible for its accuracy and completeness. Actively participates in start-up process regarding EC and RA submissions and may assist with ICF creation or update. Independently performs site evaluation/initiation, training, monitoring and closure visits and applies risk-based monitoring. Closely interacts with project team and is responsible for accurate and timely completion of reports, issues/deviation reporting and resolution.
Participates in various work groups and performs other assigned tasks.
Key ResponsibilitiesAnova-wide Clinical Trial Site Monitoring
* All governance reporting is accurate and timely, with appropriate reporting on site status.
* Sites have the proper monitoring to ensure adherence to protocol and ICH GCP standards to the satisfaction of key stakeholders.
* Lead and coordinate the execution of clinical trials from initiation to closeout.
* Oversee site selection, initiation, monitoring, and closeout visits.
* Evaluate site performance and resolve issues related to patient recruitment, protocol adherence, and data integrity.
* Ensure all trial activities comply with ethical guidelines, local regulations, and sponsor protocols.
* Work with Ethics Committees (ECs) & Regulatory Authorities (RA) for approval and submissions.
* Prepare and review essential regulatory documents, including Clinical Trial Agreements (CTAs) and Investigator Brochures (IBs).
* Independently customize and maintain the Monitoring Plan, Issues and Visit Report writing guidance, Project Specific Training material, Project Specific Training Logs.
* Independently perform CRF review; query generation and resolution against established data review guidelines or data management systems as applicable
* Identifying and escalating potential risks and identifying retraining opportunities for site personnel
* Preparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro‐active follow of each, individual CAPA until timely resolution
* Ensure overall project efficiency and adherence to project timelines; report metrics and out‐of‐scope activities to the CRA line Manager, Sponsors, or Clinical PM's.
* Collaborate with other functional groups within the company such as data management, project management, quality assurance and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles.
* Manage and follow study activities through ongoing tracking and review of study progress. Provide input and report progress to the assigned clinical project management leaders.
* Conduct review of CRA visit reports within required timeframe, track CRA compliance and proactively elevate quality or non‐compliance issues to Monitoring Management.
* Handle escalations for site management questions and issues for assigned projects.
* Identifying and escalating potential risks and identifying retraining opportunities for site personnel
* Supports audit and inspection activities as needed and may assist with on‐site CRA training and evaluation upon request.
* Preparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro‐active follow of each, individual CAPA until timely resolution
* Develop and deliver presentations & training to clients, colleagues and professionals, as required.
* May be assigned additional responsibilities as needed to support projects and other corporate/departmental initiatives.
* Host routine CRA team calls with a focus on best practice / knowledge sharing.
* Provide Central Data Review and coordinate Risk Based Monitoring strategy, as applicable.
* Independently negotiate study budgets with potential investigators/institutions and assist with the execution of site contracts as applicable
* Administration of site payments in accordance with relevant project instructions
* Travel Requirements up to 50%.
* Adhere to all aspects of Anova Evidence quality system.
* Adhere to all essential systems and processes that are required at Anova Evidence to maintain compliance to Anova Evidence's data integrity & business ethics and regulatory requirements.
* Clear and sustained demonstration of Anova Evidence's values
* Prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviours.
* Responsibilities may differ from the above based on the specific needs of the business.
Education
* Bachelor's degree level qualification in Life Sciences, Nursing Licensure or Pharmacy, at minimum;
* Project management qualification including PMO or PRINCE2 practitioner preferred;
* Understanding of change management principles.
Experience
* 6-10 years experience as a clinical research associate (required);
* Therapeutic experience in complex disease (oncology, rare disease, infectious disease, cardiology, neurology)
* Understanding of clinical and/or clinical research technology programmes (preferred);
* Monitoring experience in early phase trials (Phase I-II) and FIH trials (preferred).
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