Precision Medicine Group

Clinical Operations

• Independently lead clinical projects in accordance with the study budget and scope of work.
• Use your strong interpersonal and organizational skills to set and achieve objectives in the execution of the projects; both contracted objectives and financial objectives.
• Run international trials as required.
• Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations.
• Liaise with Project Team and senior management of both Precision and sponsors, including C level.
• Handle and lead all aspects of a clinical research trial or trials.
• Total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics, etc.
• Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation.
• Serve as an active member of the Project Team with the goal to contribute towards efficient management and execution of trials.
• Prepare and review protocols and other study documentation such as project plans, inform consents, site contracts and budgets.

Clinical Project Manager / Senior Clinical Project Manager

• Independently lead clinical projects in accordance with the study budget and scope of work.
• Use strong interpersonal and organizational skills to set and achieve objectives in the execution of the projects; both contracted objectives and financial objectives.
• Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations
• Liaise with Project Team and senior management of both Precision and sponsors, including C level
• Handle and lead all aspects of a clinical research trial or trials
• Total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics, etc.
• Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation.
• Serve as an active member of the Project Team with the goal to contribute towards efficient management and execution of trials
• Prepare and reviews protocols and other study documentation such as project plans, inform consents, site contracts and budgets

• You will independently lead clinical projects in accordance with the study budget and scope of work.
• Use your strong interpersonal and organizational skills to set and achieve objectives in the execution of the projects; both contracted objectives and financial objectives.
• Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations.
• Liaise with Project Team and senior management of both Precision and sponsors, including C level.
• Handle and lead all aspects of a clinical research trial or trials.
• Total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics, etc.
• Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation.
• Serve as an active member of the Project Team with the goal to contribute towards efficient management and execution of trials.
• Prepare and reviews protocols and other study documentation such as project plans, inform consents, site contracts and budgets.

• Independently lead clinical projects in accordance with the study budget and scope of work. • Use your strong interpersonal and organizational skills to set and achieve objectives in the execution of the projects; both contracted objectives and financial objectives. • Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations. • Liaise with Project Team and senior management of both Precision and sponsors, including C level. • Handle and lead all aspects of a clinical research trial or trials. • Total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics, etc. • Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation. • Serve as an active member of the Project Team with the goal to contribute towards efficient management and execution of trials. • Prepare and reviews protocols and other study documentation such as project plans, informed consents, site contracts and budgets.

• Independently lead clinical projects in accordance with the study budget and scope of work.
• Use your strong interpersonal and organizational skills to set and achieve objectives in the execution of the projects; both contracted objectives and financial objectives.
• Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations.
• Liaise with Project Team and senior management of both Precision and sponsors, including C level.
• Handle and lead all aspects of a clinical research trial or trials.
• Total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics, etc.
• Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation.
• Serve as an active member of the Project Team with the goal to contribute towards efficient management and execution of trials.
• Prepare and reviews protocols and other study documentation such as project plans, inform consents, site contracts and budgets.

• Independently lead clinical projects in accordance with the study budget and scope of work
• Use strong interpersonal and organizational skills to set and achieve objectives in the execution of the projects
• Serve as the primary point-of-contact liaison with the client to provide excellent customer service
• Liaise with Project Team and senior management of both Precision and sponsors, including C level
• Handle and lead all aspects of a clinical research trial or trials
• Total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics
• Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation
• Serve as an active member of the Project Team

Associate

• Review, draft, negotiate and track a variety of legal agreements including confidentiality disclosure agreements (CDA), initial clinical trial agreements (CTA), amendments to the clinical trial agreements (CTA-A), site budgets and other various types of documents
• Work closely with the Clinical Operations study team and play an administrative role to ensure deliverables are in alignment with defined project timelines and expectations
• Prepare and negotiate Agreements/Amendments such as Confidentiality Disclosure Agreements (CDA), Clinical Trial Agreements (CTA) and Amendments (CTA-A), vendor contracts and site budgets
• Lead interactions with the North American and European internal study teams, as applicable
• Lead interactions regarding the various agreements with the Site(s)
• Lead interactions regarding assigned agreements with the Sponsor(s)
• Work with supervisor and various internal/external stakeholders to resolve contractual issues
• Ensure adhered to company policies, procedures, and contracting standards
• Update relevant study team members and sponsors regarding the status of contract negotiations and execution
• Coordinate execution of the agreements
• Support the maintenance of contract files and databases, including email and document archiving
• Other duties as assigned

Senior Contracts and Budget Associate

Clinical Research

• Develop, mentor, coach and manage CTMs, and PCTMs to progress their skillset as per Precision for Medicine quality standards. Advocate individual growth and career development
• Work with the Clinical Operations Management Team and management of other functional areas to continually improve and enhance CTM expectations and procedures to promote quality, consistency and efficiency while achieving established Key Performance Indicators (KPIs)
• Collaborate with the Resourcing team to ensure Clinical Operations resource allocations and needs are appropriately met
• Generate action plans and provide developmental/strategic oversight to optimize CTM services, with a focus on high quality delivery of individual/team/departmental goals
• Provide on-going feedback and development to manage the performance of direct reports
• Provide technical support and guidance (including scope definition, risk identification, escalation and mitigation, resource planning, goals, and deliverables) to assigned CTMs
• Ensure all assigned CTMs have the proper resources, training, materials, and access to systems to deliver on the expectations of their position
• Ensure CTMs uphold high quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements
• Ensure CTMs provide timely and accurate updates of all required administrative material (SOPs, T&E, etc.) on company systems.
• Recognize, exemplify, and adhere to Precision’s values that center on our commitment to quality, our people, clients, and performance
• Perform other duties and departmental initiatives as assigned by Leadership

Manager, Clinical Trial Management

Research Analyst

• Monitor and own the progress of clinical studies at investigative sites
• Ensure that clinical studies are conducted, recorded, and reported per protocol
• Coordinate all necessary activities required to set up and monitor a study

Clinical Research Associate II

Safety Specialist

• Responsibilities will include, but may not be limited to; safety management plan development, serious adverse event (SAE, SUSARS) case management from intake to regulatory reporting, and providing safety expertise in a timely manner upon request from team members, clients, and study site personnel.
• Interfacing with sponsors, vendors, and other internal team members in the area of safety to assist in the design and implementation of safety collection tools, processes, and reporting systems.
• Participate in the assessment and set-up of a safety database to capture SAE data.
• Perform intake, triage, data entry, medical coding, expectedness assessment, and composition of narratives and analyses of similar events for individual case safety reports (ICSRs), while following applicable regulations and company policies and procedures.
• QC of documents and safety reports.
• Preparation and/or review of project-specific safety reporting plans and medical coding plans.
• Preparation and/or review of safety training materials.
• Provide safety training and oversight for consultants, contractors and/or staff.
• Review and/or draft standard operating procedures and work instructions.
• Assist clients and/or other departmental staff with safety-related reviews and other services.
• Other duties as assigned.

Drug Safety Specialist II

• Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies.
• Primary clinical point of contact with the client.
• Collaborate with PM on monthly invoicing and variance management of clinical budget.
• Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, etc.).
• Identify and develop training needs for CRAs and third-party vendors specific to the study.
• Generate potential site list from key stakeholders and drive site feasibility process.
• Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment.
• Develop timely and effective communication with investigators and study team.

Clinical Trial Manager – Senior Clinical Trial Manager

• Process ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans
• Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability
• Enters data into Argus Safety Database
• Code events, medical history, concomitant medications and tests
• Draft case narratives
• Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements
• Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases
• Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects
• Participates in audits/inspections as required
• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process

Safety Specialist II

General

• Provide overall support to study sites and clinical project teams engaged in clinical research studies
• Adhere to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH), Good Clinical Practice (GCP), and country/region-specific regulations)
• Act as point of contact for study sites
• Assist with the investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites
• May assist in identifying study sites by performing site feasibility and recruitment tasks
• Schedule internal and external meetings as required
• Prepare Investigator Site Files including distribution to study sites (electronically or physically), coordination with shipping vendor, if required
• Perform ongoing essential document collection and review, maintenance, and close-out activities, organizing and maintaining site level data
• Ensure timely and complete data entry by site in EDC or any other system that requires data entry
• Document site and Sponsor contact and study interactions in a timely and professional manner

In-House CRA II – Mexico

• Develop, negotiate global study budgets based on the requirements of a study protocol.
• Review, draft and negotiate a variety of agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendment agreements
• Work with supervisor and various internal/external key stakeholders to resolve/escalate contractual issues
• Ensure adherence to company policies, procedures and contracting standards.
• Update relevant study team members regarding the status of contract negotiations and execution.
• Coordinate execution of agreements
• Support the maintenance of contract files and databases, including contract archiving.
• Recognize where processes can be improved and take corrective action.

Contract & Budget Associate

• Monitor and own the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
• Coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.)