Precision Medicine Group · 19 hours ago
Clinical Research Associate I
United States
Full-time
Remote
New Grad, Entry Level
$76K/yr - $113K/yrPrecision Medicine Group is a company focused on improving patient outcomes through innovative research. They are seeking a Clinical Research Associate I to assist in study site management, ensuring patient safety and quality of data, while supporting various clinical trial activities under supervision.
BiotechnologyHealth Care
Responsibilities
Oversees, with supervision, 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
Updates, tracks and maintains study specific trial management tools/systems, and status reports
Support 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 department
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
Conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits with different levels of supervision as required, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs
Prepares and submits for review, accurate and timely monitoring reports from all 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 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 high quality and professional image
Performs, with different levels of supervision as required, 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
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 support 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
Travels as necessary according to project needs
Performs other duties as assigned by management
Qualification
Required
EU: University degree life science/pharmacy/other health related discipline or equivalent experience in a scientific or healthcare discipline or be a licensed health care professional
N. America: Graduate, postgraduate, 4-year college degree or equivalent experience in a scientific or healthcare discipline
Excellent communication and organizational skills are essential
A team player
Evidence of a client focused approach
Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required
Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel may be required
For focus in Oncology studies: Oncology experience in related field
Preferred
Little to no CRA experience required on entry, but transferrable skills from a related health care field desired
Experience monitoring in rare and complex therapeutic areas are preferred
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 particular country preferred
Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines
Ability to resolve project related problems and prioritizes workload to meet deadlines with support from management
Benefits
Discretionary annual bonus
Health insurance
Retirement savings benefits
Life insurance
Disability benefits
Parental leave
Paid time off for sick leave and vacation
Company
Precision Medicine Group
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market.
Founded in 2012
1001-5000 employees
H1B Sponsorship
Precision Medicine Group has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (3)
2022 (2)
2021 (1)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Mark Clein
Co-Founder & Chief Executive Officer
Matt DeZee
Chief Financial Officer
Company data provided by crunchbase