Precision For Medicine

Research Analyst

• You will 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.
• You will 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.).
• As a CRA, you will work with 2-3 protocols on average and support Project Managers with trials that are larger in scope.
• You will interact directly with clients, initiate payments, and participate in proposal activities, including development and client presentations.

Clinical Research Associate II

Strategy

• Drive and support the operational strategy considerations for RFPs, bid defense meetings (BDMs).
• Represent Precision operations at pre-award meetings.
• Lead specific projects enabling Precision for Medicine to stay at the forefront of innovation.
• Collaborate with medical, operational, business development teams on operational considerations.
• Ensure proposals reflect robust strategic, operational, scientific, medical and clinical development planning.
• Create and refine study budgets in partnership with other functional leadership.
• Mentor and train Operational Strategy colleagues and Precision colleagues.

Operational Strategy Director – Oncology

• Monitor and own the progress of clinical studies at investigative sites
• 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.)

Clinical Research Associate I/II

Compliance

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team.
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership.
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Form.
• Responsible for/facilitates the translation and co-ordination of translations for documents.
• Maintain communication with other key functions participating to country start up e.g., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/or study specific plans in the relevant TMF.
• May support the clinical team performing Pre-Study Site Visits.

Regulatory and Start Up Specialist

• You will 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.
• You will 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.).

• 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.)

• Monitor and own the progress of clinical studies at sites
• Ensure studies are conducted per protocol and standards
• Coordinate activities required to set up and monitor a study

• Monitor and own the progress of clinical studies at investigative sites• Ensure clinical studies are conducted, recorded, and reported per protocol• Coordinate necessary activities required to set up and monitor a study• Handle appropriately sized clinical trials and support larger trials• Interact directly with clients and participate in proposal activities• Train and mentor junior staff members

Clinical Research Associate II

Operational Strategy Director – Oncology

Clinical Research Associate I/II

Regulatory and Start Up Specialist

Clinical Research Associate II

Clinical Research Associate I/II

Clinical Research Associate I/II

Senior Clinical Research Associate