Senior Clinical Research Associate

Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Baim Institute for Clinical Research Director, Human Resources at Baim Institute for Clinical Research The Sr. Clinical Research Associate/Field Monitor Contractor performs remote and on-site visits, such as, Qualification, Site Initiation, Interim Monitoring and Study Close-out Visits, in accordance with the Monitoring Plan. Responsibilities include ensuring the site study staff conduct the study in compliance with the currently approved protocol/amendment(s), Baim Institute’s Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH)/Good Clinical Practices (GCPs), and applicable regulatory requirements, performing source document verification, query resolution, collaborate with in-house Clinical Research Associate (CRA) team, ensuring regulatory documents and the Investigator Site Files (ISFs) are complete and current. Regional CRA position is a remote position who is able to travel regionally up to 60% and is expected to work collaboratively with internal and external project team members. Primary Duties: Responsible for overall on-site and remote monitoring activities of assigned clinical sites. Independently conduct all types of monitor visits onsite qualifying site assessments, recruitment, initiation, for-cause, interim and closeout, and/or remote visits as needed, in accordance with Monitoring Plan. Perform source document verification/review in accordance with Monitoring Plan. Collect, review for appropriate content and submit regulatory documents as necessary. Review ISF and resolve essential regulatory document deficiencies in a timely manner. Perform Informed Consent Form (ICF) reconciliation, to ensure all subjects have signed the correct ICF version. Query generation and manage to resolution. Identify and resolve site level quality issues and implement Corrective and Preventative Actions (CAPAs) in a timely manner, in coordination with SM Lead and/or in-house CRA Comply with Trial Master File (TMF) document submission timelines Update and maintain CTMS, ensure that it is up-to-date and accurate Provide site support, communication and coordination to assure accurate and timely completion of all contracted activities: Effectively perform Protocol and other study training to investigator and site study staff. Schedule and conduct visits in accordance with Monitoring Plan. Collaborate with Study Team during start-up activities. Complete visit reports, confirmation letters, and follow up letters on time,in accordance with Monitoring Plan and/or Baim Institute’s SOPs and Guidelines. Close out action items identified during site visits, in a timely manner. Knowledge of pertinent study milestones. Establish a strong working relationship with site study staff and Baim Institute project team members. Responsible to schedule visits with site study staff and conduct follow-up of action items and queries. Co-monitor as needed. Attend and participate in investigator and coordinator meetings. Assist with site preparation for audits (Regulatory Agency, Sponsor, etc.). Attend Baim CRA meetings. Demonstrate a high working knowledge of internal SOP’s, FDA/ICH guidelines to GCP’s and regulatory compliance. Demonstrate effective leadership skills. Must demonstrate in-depth knowledge of the study protocol. Maintain an effectual working relationship with Sponsors, the Principal Investigator, Site Study Staff, and Baim Institute team members. Work independently and in a team environment. High level of attention to detail and work in an organized manner. Effective ability to multi-task and work in a fast pace environment. Knowledgeable with common software packages (Word, Excel, PowerPoint, Outlook) Knowledgeable of Clinical Trial Management System. Knowledgeable of Electronic Data Capture System (e.g InForm, IBM Clinical, iMedNet, eCOS, IWRS). Ability to quickly learn new software packages. Requirements: Education: Required: BS Degree in science/health related field, or nursing experience, or other clinical trial related experience. Yrs. of related experience: Required: At least 5-8 years clinical research experience required in a pharmaceutical, biotech or CRO setting with a minimum of 8 years of independent clinical monitoring. Travel: May be expected to conduct 2-4 visits per month, travel regionally up to 60%, although percent of travel is dependent on study specific needs. Seniority level Seniority level Mid-Senior level Employment type Employment type Part-time Job function Job function Project Management and Research Industries Non-profit Organizations, Pharmaceutical Manufacturing, and Research Services Referrals increase your chances of interviewing at Baim Institute for Clinical Research by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Paid maternity leave Pension plan Tuition assistance Disability insurance Get notified about new Clinical Research Associate jobs in United States . 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