Experienced Clinical Research Associate – Sponsor Dedicated

This is a fully remote position, open to applicants in Arizona, +4 more states.

📋 Description

• Conducts site qualification, initiation, interim monitoring, site management activities, and close-out visits, either on-site or remotely, ensuring compliance with regulatory standards, ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and protocols.

• Utilizes judgment and experience to assess the overall performance of the site and its staff, providing recommendations for site-specific actions; escalates serious issues to the project team promptly and formulates action plans.

• Maintains an up-to-date understanding of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.

• Ensures proper performance and documentation of informed consent for each subject/patient as required.

• Demonstrates commitment to protecting the confidentiality of all subjects/patients.

• Evaluates factors that may impact the safety of subjects/patients and the integrity of clinical data at investigator/physician sites, including protocol deviations and pharmacovigilance issues.

• Reviews site processes in line with the Clinical Monitoring/Site Management Plan (CMP/SMP).

• Conducts Source Document Reviews of relevant site documents and medical records.

• Confirms the accuracy and completeness of clinical data entered in case report forms (CRFs).

• Implements query resolution techniques both remotely and on-site, providing necessary guidance to site staff and ensuring timely closure of queries.

• Leverages available hardware and software to enhance the efficiency of clinical study data review and capture.

• Verifies compliance with electronic data capture requirements at the site.

• May oversee investigational product (IP) inventory, conduct reconciliations, and review storage and security protocols.

• Ensures the IP is dispensed and administered to subjects/patients per the protocol.

• Assesses issues or risks associated with blinded or randomized information related to IP.

• Applies knowledge of GCP/local regulations and organizational procedures to guarantee proper (re)labeling, importation, and return of IP.

• Regularly reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness.

• Reconciles the contents of the ISF with the Trial Master File (TMF).

• Informs the investigator/physician site of the requirements for archiving essential documents according to local guidelines and regulations.

• Documents activities through confirmation letters, follow-up letters, trip reports, communication logs, and other project documents as per SOPs and the Clinical Monitoring Plan/Site Management Plan.

• Aids in subject/patient recruitment, retention, and awareness strategies.

• Inputs data into tracking systems as necessary to monitor observations, ongoing statuses, and action items until resolution.

• Understands project scope, budgets, and timelines for assigned activities; manages site-level activities and communication to meet project objectives, deliverables, and timelines.

• Must be able to quickly adapt to changing priorities to achieve goals and targets.

• May serve as the primary liaison with study site personnel or collaborate with the Central Monitoring Associate.

• Ensures training and compliance of all assigned sites and project-specific site team members with applicable requirements.

• Prepares for and participates in Investigator Meetings and/or face-to-face meetings with sponsors.

• Engages in global clinical monitoring/project staff meetings (including Sponsor representation, as applicable) and attends clinical training sessions as per project requirements.

• Provides site and project-level guidance towards audit readiness standards and assists in preparation for audits and necessary follow-up actions.

• Maintains knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes; completes assigned training as required.

• Offers site support throughout the study lifecycle from site identification through close-out.

• Familiarity with local requirements for real-world late-phase study designs.

• Conducts chart abstraction activities and data collection.

• Collaborates with Sponsor affiliates, medical science liaisons, and local country staff.

• Identifies and communicates out-of-scope activities to the Lead CRA/Project Manager.

• Proactively recommends potential sites based on local knowledge of treatment patterns, patient advocacy, and Health Care Provider (HCP) associations.

⛳️ Requirements

• Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Must possess strong computer skills and be open to adopting new technologies.

• Excellent communication, presentation, and interpersonal skills.

• Ability to manage required travel of up to 75% regularly.

🏝️ Benefits

• Company car or car allowance.

• Health benefits including Medical, Dental, and Vision.

• Company-matched 401k.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions/bonuses based on individual and company performance.

• Flexible paid time off (PTO) and sick time.