Performs monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on-site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Proxima and Sponsor standard operating procedures (SOPs), ICH-GCP and/or all applicable local and federal regulatory requirements. Performs all tasks routinely and independently, seeking guidance as needed. CRA III/Sr. - May assume clinical functional leadership tasks as assigned, acting as Lead CRA for a project or assessor of peers for sign-off visit purposes.
A DAY IN THE LIFE
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits, on-site or remotely, ensuring regulatory, ICH-GCP, monitoring plan, and protocol compliance.
Conducts source document review of appropriate site source documents and medical records. Verifies the required clinical data entered in the case report form is accurate and complete and utilizes query resolution techniques remotely and on-site.
Performs investigational product inventory and reconciliation, reviewing storage and security parameters. Verifies IP dispensation and accountability according to the protocol.
Verifies site informed consent process is adequately performed and documented for each subject.
Routinely reviews the Investigator Site File for accuracy, timeliness, and completeness. Reconciles the ISF with the Trial Master File and collects any outstanding documents.
Serves as the primary point of contact with study site personnel. Documents all activities and communications with the site via confirmation letters, follow-up letters, monitoring visit reports, communication logs, and other required project documentation. Follows up on action items to ensure timely completion.
Trains site staff on protocol, study procedures, EDC, and any other study-specific requirements or systems
Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in clinical monitoring/project staff meetings and attends clinical training sessions according to the project-specific requirements.
May review draft protocols, eCRFs, study manuals, and other study-related documents and templates, as requested by the Project Manager
Prepares and coordinates documentation with site for IRB applications and renewals, as needed.
Routinely communicates with internal Proxima and Sponsor project teams, escalating issues, and develops action plans.
May conduct evaluation visits and field training of CRA Is, and CRA IIs
Attendance at internal Proxima meetings, completion and proper submission of timesheets and documentation of training
Adherence to Proxima or client Standard Operating Procedures (as applicable)
Professionally represents Proxima in business interactions
KNOWLEDGE AND SKILLS
Bachelor’s degree, ideally within a scientific or healthcare field, a healthcare certification, or an equivalent combination of education, training and experience.
CRA II - A minimum of 2 years field monitoring experience with 5 years overall clinical research experience.
CRA III - A minimum of 5 years field monitoring experience with 10 years overall clinical research experience.
Sr. CRA - A minimum of 10 years field monitoring experience with 15 years overall clinical research experience.
Must have a thorough understanding of current ICH/GCP and FDA regulations pertaining to clinical research.
Ability and willingness to travel domestically 20%-80%
Strong interpersonal skills and ability to forge relationships with clinical sites and colleagues.
Excellent oral and written communication skills, with the ability to articulate issues.
Self-management skills, including the ability to multi-task.
Attention to detail and accuracy in work.
Well organized, with strong problem solving and time management skills.
Proficient in the use of Microsoft Office applications.
2 openings. Telecommuting is allowed.
About Proxima Clinical Research
Proxima is a CRO who works with the new class of rising stars in drugs, diagnostics, devices and digital health. We help emerging companies overcome regulatory and clinical obstacles to get their medical product approved. We are a rapidly growing organization, looking for hungry, humble, happy and helpful folks to join the team.