PSI CRO

Title: Lead Clinical Research Associate Location: Remote, US, United States Full-time Company Description PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description As a Lead Clinical Research Associate, you will hold a leadership role within the study team, overseeing and guiding the clinical team while driving trial activities at a country or regional level. You will ensure high-quality execution, compliance, and timely delivery. You will act as a key point of coordination across cross-functional teams. This role focuses on leadership, mentorship, oversight, and consistency in monitoring practices rather than direct site management, with minimal to no site assignments and a low-travel model, emphasizing remote oversight and overall study quality. Responsibilities: - Monitors project timelines, patient enrollment, data cleaning, and ensuring compliance while implementing respective corrective and preventive measures. - Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region. - Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager. - Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager. - Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead. - Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level. - Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level. - Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level. - Ensures data integrity and compliance at a site level. - Collaborates with investigator/ site feasibility and identification process, as well as study startup. - Manages Monitors in the query resolution process, including Central Monitoring observations. - Coordinates safety information flow and protocol/process deviation reporting. - Performs clinical supplies management with vendors on a country and regional level. - Ensures study-specific and corporate tracking systems are updated in a timely manner. - Coordinates planning of supervised monitoring visits and conducts the visits. - Manages the project team in site contracting and payments. - Ensures ongoing evaluation of data integrity and compliance at a country/regional level. - Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level. - Oversees project team in CAPA development and implementation. - Coordinates project team in process deviations review, management and reporting. - Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs. - Delivers trainings and presentations at Investigator Meetings. - Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level. - Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations. - Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer. - Supports preparation of draft regulatory and ethics committee submission packages. Qualifications - Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience. - Minimum of 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level. - Experience with all types of monitoring visits in Phase II and/or III. - Strong experience in Oncology preferred. - Experience in Radiation Therapy or Radiopharmaceuticals, CAR-T Therapy or other types of Cell Therapy, Gene Therapy, or Nuclear Medicine is preferred. - Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred. - Full working proficiency in English. - Proficiency in MS Office applications. - Ability to plan, multitask and work in a dynamic team environment. - Excellent Communication, collaboration, and problem-solving skills. - Ability to travel. - Valid driver’s license (if applicable). Additional Information If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

Title: Medical Monitor (Canada Board-Certified Gastroenterologist) Location: Remote, Canada Job Description: - Employees can work remotely - Full-time - Compensation: CAD 170,000 - CAD 185,000 - yearly Company Description PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being. Home-Based in Canada Responsibilities: - Acts as the primary point of contact for all parties on all trial-specific medical and safety-related questions - Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions - Monitors trial participant safety - Participates in trial participant recruitment boost and retention activities - Presents on medical matters at kick-off and investigator meetings - Trains trial team in the therapeutic area and medical aspects of the protocol - Develops and reviews trial-specific documents within the scope of medical monitoring - Manages ongoing trial risks related to medical monitoring - Performs ongoing medical review of the operational clinical trial database; provides support to Medical Reviewer(s) assigned to the trial - Reviews protocol deviations - Reviews RAE reports, writes and/or reviews SAE narratives, supports Pharmacovigilance team with outstanding safety queries, interacts with sponsor on site safety issues - Reviews IND/SUSAR Safety Reports, updates/amendments to essential trial records, and annual IND reports with sponsor data (per sponsor request) - Participates in management of trial-related committees (e.g., independent data monitoring committee (IDMC)/adjudication committees) as described in the corresponding trial-specific charter(s) - Supports Pharmacovigilance, Medical Data Review and Data Management with reconciliation of safety and operational clinical trial databases - Reviews clinical study reports (CSRs), including safety narratives and tables, figures, and listings (TFLs) - Provides medical expertise on an as-needed basis in trials where medical monitoring is not a contract deliverable - Prepares for and participates in trial audits, follows up on audit findings - Participates in feasibility assessment of potential and ongoing trials in the country/region - Participates in bid defense meetings and other interactions with clients - Acts as a medical expert and provides therapeutic expertise to other PSI departments Qualifications - Medical Doctor degree required - Canada Board Certification in Gastroenterology required - Experience as a practicing Gastroenterology (minimum of 10 years) - Clinical Research experience preferred - Proficiency with MS Office applications - Communication, presentation and analytical skills - Problem-solving, team and detail-oriented Additional Information As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.

Title: Proposal Manager Location: Mississauga, ON, Canada Job Description: Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 3,200 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. Job Description At PSI, Proposal Manager coordinates all phases of PSI’s proposal process while maintaining the company’s win rate of 30% and higher. You will contribute to everything from RFP strategy to bid defense slide decks. You will partner with global teams of subject matter experts from Feasibility, Medical Affairs, Project Management, Clinical Operations, Budgeting, and Business Development to rapidly produce winning proposals. This position is home-based This full proposal development cycle will include: - Preparing viable RFP calendars and ensuring RFP milestones are met by all involved individuals in a timely manner - Organizing, attending, and leading strategy calls for each RFP; preparing and distributing minutes/action items - Developing draft budgets: reviewing clients’ specifications, obtaining quality feedback from various stakeholders within the company - Working with the budgeting team to develop competitive budgets and obtaining missing costs - Preparing vendor RFPs and obtaining vendor quotes - Writing strategic proposals that meet our clients’ needs - Providing support for bid defense meetings - Maintaining all RFPs in Salesforce and PSI’s CTMS Qualifications - A minimum of a four-year degree from an accredited college or University - Experience managing full-service clinical trial proposals at a CRO - Writing and editing skills - Analytical skills - Time management and organization skills - Ability to manage multiple assignments under deadlines - Proven track record of proposal win rates - Flexibility and creativity in responding to potential clients - Proficiency in Microsoft Word, Excel and PowerPoint Additional Information This is a creative tight-knit team of professionals motivated by producing quality proposals that resonate with our customers. Our culture is open, collaborative, and purposeful. We’re now looking for talented people who don’t believe in one-size-fits-all templates and have a passion for writing proposals that get read and remembered.