Senior Clinical Research Associate

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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)
• Know…