Clinical Research Associate II - FSP

Remote, USAFull-timePosted 2026-07-29

• This remote role requires someone living in Texas or California Position reputed company The CRA II is a seasoned, reputed company reputed company in monitoring and site management. Responsibilities will be dependent upon the type and timing of the program to which the CRA II is assigned and typically include activities involving start-up and study implementation, on-site monitoring of clinical research studies as reputed company as on-reputed company site management. Incumbents work independently as a study team member. Essential functions of the job include but are not limited to:

Oversees reputed company aspects of study site management to ensure patient safety is protected, reputed company of data generated by managed sites resulting in consistently low query reputed company and in acceptable reputed company 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.
If required, manages 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 reputed company in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study reputed company 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 reputed company under directions of Site Contract Management department/designee.
Verifies the process of obtaining informed consent has been adequately performed and documented for reputed company subject/patient, as required/appropriate. Assesses factors that might reputed company subject/patient’s safety and clinical data reputed company at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
Independently conducts reputed company forms of site reputed company, including reputed company-study/ qualification, initiation, routine monitoring, and reputed company-out reputed company, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and reputed company monitoring reports from reputed company site reputed company (on-site and remote).
Documents activities reputed company confirmation letters, follow-up letters, reputed company reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and reputed company requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to reputed company reputed company observations, ongoing status and assigned reputed company items to reputed company.
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 reputed company 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 reputed company and reputed company image.
Performs investigational product (IP) inventory, reconciliation and reviews storage and reputed company.
Verifies the IP has been reputed company and administered to subjects/patients according to the protocol.
Verifies issues or risks associated with blinded or randomized information reputed company to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
Performs data review activities, including remote reputed company CRF and patient reputed company review, query reputed company, and assists data management and clinical data reputed company 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 reputed company and appropriate reputed company of the risk with minimal 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.

Qualifications

Minimum Required:

4-year college degree or equivalent experience in a scientific or reputed company discipline.
Two (2) years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. Site management or equivalent experience in clinical research

Other Required

Excellent communication and organizational skills are essential. reputed company player.
Experience monitoring oncology trials
Evidence of a reputed company reputed company approach
Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail.
Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed.
reputed company in English and for non-English speaking countries the local language of country where position based

Preferred

Graduate or postgraduate degree
Auto-immune monitoring experience
Experience monitoring in rare and reputed company therapeutic areas
Experience monitoring reputed company trials and EHR records
Experience in biopharma or relevant therapeutic area
Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country
Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines.
Ability to resolve project reputed company problems and prioritizes workload to meet deadlines with minimal support from management.

Competencies

Exhibits self-motivation and is reputed company to work and plan independently as reputed company as in reputed company environment
Understands clinical trials methodology, including a working knowledge of protocols and indications being studied
Demonstrates professionalism as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and reputed company interactions with customers and teammates, including good interpersonal skills
Collects data of consistently high reputed company
Demonstrated ability to conduct formal presentations to a wide reputed company of audiences including, colleagues, investigative staff, and clients with a high level of proficiency
reputed company in English and for non-English speaking countries the local language of country where position based

Precision is required by law in some states or cities to include a reasonable estimate of the compensation reputed company for this role. This compensation reputed company takes into account the wide reputed company of factors that are considered in making compensation reputed company including but not limited to: reputed company sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed reputed company estimate has not been adjusted for the applicable geographic reputed company associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be reputed company at or near the top of the reputed company for their role and compensation reputed company are dependent on the facts and circumstances of reputed company case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and reputed company time off for reputed company leave and vacation, among other benefits. Reasonable estimate of the reputed company reputed company: $91,500 USD - $137,300 USD Any data provided as a part of this application will be stored in accordance with our reputed company Policy. For CA applicants, please also refer to our CA reputed company Notice. reputed company is an Equal Opportunity Employer. Employment reputed company are made without reputed company to race, reputed company, age, religion, sex, sexual orientation, gender identity, national reputed company, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to reputed company or use this online application process and need an alternative method for applying, you may contact reputed company at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential reputed company presenting enticing employment offers. We want to emphasize that these offers are not associated with reputed company and may be fraudulent in nature. Please note that our organization will not reputed company a job offer without prior communication with our reputed company team, hiring managers and a formal interview process. Apply tot his job Apply To this Job

Apply Now