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

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
• Other job duties as assigned 

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.
• Understands clinical trials methodology, including a working knowledge of protocols and indications being studied.
• Demonstrated ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.
• Demonstrated focus on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.

#LI-AG2 #LI-REMOTE

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

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
• Other job duties as assigned 

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.
• Understands clinical trials methodology, including a working knowledge of protocols and indications being studied.
• Demonstrated ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.
• Demonstrated focus on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.

#LI-AG2 #LI-REMOTE

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Senior Feasibility Associate to join our team at Precision for Medicine!

As part of this team, you'll support the delivery of pre-award, post-award, rescue, and stand-alone-feasibility projects. The Senior Feasibility Associate supports pre-award feasibility projects and support business development and operational strategy teams by conducting global feasibility analyses. The Senior Feasibility Associate supports feasibility projects for newly awarded and/or ongoing clinical trials and supports start-up and clinical teams with site identification. In addition, Senior Feasibility Associate may participate in specific projects that enables Precision for Medicine to stay at the forefront of innovation and maintain their competitive edge as a scientifically driven engaged partner for our biotech and pharma clients.

Essential functions of the job include but are not limited to:

• Support pre-award feasibility projects
• Provide pre-award feasibility analysis and input for pre-award RFPs, including competitive analysis, historical recruitment analysis, standards of care, drug analysis, epidemiology analysis, site and country analysis.
• Review clinical protocols, study assumptions, client information and study plans for US and global trials.
• Present and explain feasibility analysis to BD/Clients, including the process, recommendations, and rationale.
• Interface with colleagues, consultants and partners and collaborate with internal and external sources to gather and share feasibility information.
• Undertake feasibility site outreach for pre award opportunities.
• Participate and/or contribute to BDM and client calls.
• Apply process, templates and delivery standards for feasibility pre-award.
• Provide support to post-award feasibility projects
• Undertake post-award, rescue, and standalone feasibility deliverables in alignment with study and client requirements.
• Provide management of feasibility project team pertaining to the conduct of the feasibility:
• Provide training and training materials.
• Ensure accuracy and quality of the survey data.
• Oversee and /or conduct the site outreach process.
• Participate and or/contribute to feasibility KOM and feasibility progress meetings with the sponsor.
• Where appropriate, engage with patient advocacy groups and site networks to support study feasibility, recruitment, and successful delivery.
• Support the analysis of the collected site data to provide accurate site identification, enrollment modeling and study strategy (ies)
• Apply process, tracking, templates, data structure delivery standards for post award and stand-alone feasibility.
• Work closely with the Precision study teams to assess required input from the feasibility team, and agree on delivery plan, including roles and responsibilities, for feasibility pre- and post-award.
• Follow post and pre award feasibility process, SOPs templates and tools.

Qualifications:
Minimum required:

• Bachelor’s degree in a life sciences discipline
• A minimum of 5 years of related experience
• Combination of qualifications and equivalent relevant experience may be accepted as an alternative.

Other Required:

• Relevant experience in the required activities for the role including feasibility analysis, site identification.
• Domestic and international travel including overnight stays.
• Ability to communicate both verbally and in writing at the English proficiently (Professional level)

Preferred:

• Postgraduate degree preferred.

Skills:

• Strong management and organizational skills
• Excellent oral and written communication skills in English
• Strong rationale and analytical thinking
• Strong IT platform and data analysis skills
• Strong presentation abilities
• Advanced computer skills, specifically with MS Word, Excel, PowerPoint, and with web/data-based platforms

Competencies:

• Strong sense of ownership and pride in quality of outputs
• Good to strong attention to detail
• Team player
• Willingness to work in a matrix environment, work independently and as part of a dynamic team.
• Demonstrates knowledge of ICH-GCP

#LI-AG2 #LI-REMOTE

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Senior Feasibility Associate to join our team at Precision for Medicine!

As part of this team, you'll support the delivery of pre-award, post-award, rescue, and stand-alone-feasibility projects. The Senior Feasibility Associate supports pre-award feasibility projects and support business development and operational strategy teams by conducting global feasibility analyses. The Senior Feasibility Associate supports feasibility projects for newly awarded and/or ongoing clinical trials and supports start-up and clinical teams with site identification. In addition, Senior Feasibility Associate may participate in specific projects that enables Precision for Medicine to stay at the forefront of innovation and maintain their competitive edge as a scientifically driven engaged partner for our biotech and pharma clients.

Essential functions of the job include but are not limited to:

• Support pre-award feasibility projects
• Provide pre-award feasibility analysis and input for pre-award RFPs, including competitive analysis, historical recruitment analysis, standards of care, drug analysis, epidemiology analysis, site and country analysis.
• Review clinical protocols, study assumptions, client information and study plans for US and global trials.
• Present and explain feasibility analysis to BD/Clients, including the process, recommendations, and rationale.
• Interface with colleagues, consultants and partners and collaborate with internal and external sources to gather and share feasibility information.
• Undertake feasibility site outreach for pre award opportunities.
• Participate and/or contribute to BDM and client calls.
• Apply process, templates and delivery standards for feasibility pre-award.
• Provide support to post-award feasibility projects
• Undertake post-award, rescue, and standalone feasibility deliverables in alignment with study and client requirements.
• Provide management of feasibility project team pertaining to the conduct of the feasibility:
• Provide training and training materials.
• Ensure accuracy and quality of the survey data.
• Oversee and /or conduct the site outreach process.
• Participate and or/contribute to feasibility KOM and feasibility progress meetings with the sponsor.
• Where appropriate, engage with patient advocacy groups and site networks to support study feasibility, recruitment, and successful delivery.
• Support the analysis of the collected site data to provide accurate site identification, enrollment modeling and study strategy (ies)
• Apply process, tracking, templates, data structure delivery standards for post award and stand-alone feasibility.
• Work closely with the Precision study teams to assess required input from the feasibility team, and agree on delivery plan, including roles and responsibilities, for feasibility pre- and post-award.
• Follow post and pre award feasibility process, SOPs templates and tools.

Qualifications:
Minimum required:

• Bachelor’s degree in a life sciences discipline
• A minimum of 5 years of related experience
• Combination of qualifications and equivalent relevant experience may be accepted as an alternative.

Other Required:

• Relevant experience in the required activities for the role including feasibility analysis, site identification.
• Domestic and international travel including overnight stays.
• Ability to communicate both verbally and in writing at the English proficiently (Professional level)

Preferred:

• Postgraduate degree preferred.

Skills:

• Strong management and organizational skills
• Excellent oral and written communication skills in English
• Strong rationale and analytical thinking
• Strong IT platform and data analysis skills
• Strong presentation abilitiesAdvanced computer skills, specifically with MS Word, Excel, PowerPoint, and with web/data-based platforms

Competencies:

• Strong sense of ownership and pride in quality of outputs
• Good to strong attention to detail
• Team player
• Willingness to work in a matrix environment, work independently and as part of a dynamic team.
• Demonstrates knowledge of ICH-GCP