Job Description
Primary Job Function:
The Clinical Research Associate manages sites through life of trial and close-out, including, the implementation, coordination and conduct of clinical research activities in compliance with applicable Corporate and Divisional Policies and Procedures. Participate in site selection, provide feedback in the protocol development and database development; investigator meetings.
Core Job Responsibilities:
Under supervision of the Clinical Manager, responsible for the following:
• Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
• Ensures compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/study coordinators and site staff.
• Communication with site staff including coordinators, clinical investigators, and their site staff;
• Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
• Source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
• Verification that the investigator is enrolling only eligible subjects/samples;
• Ensures timely collection and review of study and regulatory documentation by obtaining, maintaining and controlling all necessary records and documentation according to procedures and regulations.
• Responsible for investigational product accountability and inventory;
• Verification and review of adverse events to confirm accurate data reporting in accordance with the protocol.
• Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement;
• Timely completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
• Builds and maintains relationships with sites.
• Intermediate knowledge in regulations for applicable geographies and types of studies (IDE, non-significant risk, feasibility, exempt, etc.).
• Ensures validity of study by identifying/resolving discrepancies and obtaining missing data.
• Basic knowledge of the companies Platforms, assays, and assay data.
• Basic knowledge of statistics
• Contributes to developing and writing clinical protocols, informed consent forms, case report forms, and other study aids for investigational products by addressing issues by interacting with appropriate personnel.
• Demonstrates initiative and problem-solving skills; critical-thinking skills.
• Aptitude to provide solutions and contingency plans through the comprehensive review of alternatives;
• Performs Quality Assurance Verification.
• Responsible for training peers
• Serves as a trainer for contract research organizations (CROs) needed for additional monitoring support.
• Participates on at least 2 projects
Note: This job description is not to be considered an exhaustive statement of duties, responsibilities or requirements and does not limit the assignment of additional duties for this role.
Position Accountability
Reporting and Peer Relationships:
This intermediate level position reports to the Clinical Operations Manager.
This position will interface with Clinical Project Teams, Research and Operational Managers who determine study objectives and resource needs.
Position Scope
Begins establishing and cultivating a network of internal resources to facilitate completion of tasks. Will perform this job in a quality system environment. Completes daily work to meet established schedule with guidance from supervisor on prioritization of task. May exercise authority within pre-established limits and approval; some independent decision making. Individual influence is typically exerted at the peer level.
Minimum Education
Bachelor's (life sciences or clinical research preferred) or equivalent combination of education and work experience.
Minimum Experience / Training Required
2-4 years clinical research experience required or equivalent related work experience with a good understanding of specified functional area, application of business concepts, regulations, procedures and practices.
Clinical Research certification (e.g. ACRP, SOCRA) desired.
Must be detail-oriented and able to multitask, prioritize, and efficient in time management.
Must have excellent written and verbal communication, and presentation skills.
Must have strong organizational and project management skills;
Must be able to work independently and in groups; ability to work cross-functionally;
Self-directed and able to work within a fast paced and constantly changing environment.
Strong computer skills, including Microsoft Office Suite (Word, Excel, Outlook, etc.).
Member of the clinical team responsible for conducting Phase I-IV single or multi center studies according to Federal Regulations and ICH guidelines. Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions. Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study summary. 3-5 Years Experience Level.
This position is NonExempt. Hours over 40 will be paid at Time and a Half.
Pay ranges between $25-30.15/hr based on experience
Job Tags
Contract work, Work experience placement,