Senior Clinical Research Associate (Chile)

We’re expanding our capabilities across Latin America , and we’re hiring a Senior Clinical Research Associate to support critical studies across Chile!

As a Senior CRA you'll posses a wide-ranging and broad experience handling our most complex and advanced assignments.

Responsibilities will be dependent upon the type and timing of the program to which the Senior CRA is assigned and will, at a minimum, include start-up and study implementation activities, on-site monitoring of clinical research studies as well as on-going site management.

Incumbents are expected to be able to manage appropriately sized or complex clinical trials, and support Clinical Trial Managers and/or Project Managers with trials as required. An increased focus on training and mentoring junior staff members may be expected.

Responsibilities

Independently oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports

Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions

Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports

Manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager

If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee

Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. 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

Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Performs Monitoring Oversight Visits to assess other CRA team members. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote)

Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. 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

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

Communicates effectively and proactively with both site personnel and Precision's Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues

Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision's high quality and professional image

Performs 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

Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies

Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process

Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with oversight from project team

Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. May prepare or assist in preparation of study-specific presentations/training materials and tools

Assists the team managers in the preparation and review of protocols and other study documentation

Supports the design and development of CRFs and clinical trial documents as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.)

Assists with review of clinical study reports

Functions as a mentor, assisting with the training and developing of new employees and junior monitors

Interacts with client, participates in proposal activities, including development and client presentations

Initiates payment requests for investigators

Travels as necessary according to project needs

Minimum Education & Experience

4-year college degree or equivalent experience in a scientific or healthcare discipline

5 years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies

Significant site management experience or equivalent experience in clinical research

Ability to communicate both verbally and in writing at the English proficiently (Professional level)

Preferred Education & Experience

Graduate, postgraduate degree

Experience monitoring in rare and complex therapeutic areas

Experience monitoring EDC trials and EHR records

Experience in biopharma or relevant therapeutic area

Relevant site start-up (feasibility, contract negotiations, submissions) experience for the country

Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines

Ability to resolves project related problems and prioritize workload to meet deadlines with oversight from management. Can assist junior CRAs in problem resolution

Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed

Select opportunities require Oncology experience preferably in early phases

Exhibits self-motivation and is able to work and plan independently as well as in a team environment.