Clinical Research Associate I

Precision Medicine Group

About The Position

Position Summary: The CRA responsibilities will be dependent upon the type and timing of the program to which the CRA is assigned and will typically include activities involving start-up and study implementation, on-site monitoring of clinical research studies as well as on-going site management. Incumbents work under directions provided by more senior study team members and may include shadowing other more senior CRAs on their activities.

Requirements

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

Nice To Haves

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
Exhibits self-motivation and is able to work and plan independently as well as in a team environment.
Ability to understand clinical trials methodology, including a working knowledge of protocols and indications being studied following onboarding.
Demonstrated professionalism as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
Collects data of consistently high standard
Fluency in English and for non-English speaking countries the local language of country where position based

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