Clinical Research Associate 3

Role Summary

The Clinical Research Associate assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Ensures coordination of an accelerated study start-up including pre-study visits, initiation, interim, and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study.

Responsibilities

• Tracking study specific tasks and progress of the trial.
• Performing regulatory document review and approval for IP release.
• Assisting in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings).
• Conducting monitor training.
• Performing monitoring/co-monitoring activities for site initiation visits, interim site monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies.
• Understanding and implementing processes for distribution and tracking of SAE’s, safety documentation, and pregnancies. Monitors compliance of these processes.
• Collaborating with data management to resolve queries.
• Facilitating investigator site payments, as applicable.
• Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation.
• Assisting in evaluation of vendor performance during conduct of the study.
• Acquiring a basic knowledge of the therapeutic area and product.
• Obtaining a complete understanding of all trial-related documents and operational procedures.
• Gaining exposure/participates in CRF development, IVRS set-up, central lab set-up, and other vendor selection processes.
• Maintaining clinical trial management system (CTMS) information pertaining to the study as applicable
• Assisting with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation).
• Reviewing and tracking study documents, including: project files both electronically and in the Trial Master File and Project Status Reports.
• Preparing accurate and complete meeting minutes for various meetings.
• Communicating and interacting with relevant study personnel, including: develops and maintains collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to study manage; troubleshoots and follows up on study progress; and, reviews report data for completeness and accuracy.
• Assists with effective and timely audit/inspection responses.

Responsibilities (cont.)

• For studies monitored in house by Grifols, additional responsibilities may include:
• Identifies/screens/qualifies investigators through feasibility questionnaires and pre-study visits.
• Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up.
• Conducts/oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine protocol and regulatory compliance.
• Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
• Reconciles clinical supplies and drug accountability records at study sites.
• Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required.
• Reviews, clarifies, and obtains, data changes via query resolutions with site personnel.
• Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to accurately and completely document site status and activities.

Qualifications

• Associate’s degree in a life science field required. Bachelor’s degree in a life science field preferred.
• Typically requires 5 years of experience in clinical research, including a minimum of 2 years field monitoring experience and 3 years in lead CRA role.
• Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.

Knowledge, Skills, And Abilities

• Excellent knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs.
• Excellent knowledge of therapeutic area assigned.
• Excellent knowledge of ICH/GCP Guidelines and EDC process.
• Strong verbal and written communication skills.
• Ability to train others in using MS Office Suite, Impact, and EDC systems.
• Ability to meet deadlines, multitask, and prioritize based on study needs.
• Ability to make sound decisions based on available information.
• Ability to establish rapport with site personnel/ colleagues.
• Ability to work both in a team and independently.
• Ability to facilitate team meetings and teleconferences.
• Ability to present at internal study team meeting(s).
• Ability to train and mentor junior CRAs.
• Ability to seek new learning opportunities within and outside of the assigned project.
• Ability and willingness to travel.

Education

• Associate’s degree in a life science field required. Bachelor’s degree in a life science field preferred.

Additional Requirements

• Occupational Demands include office environment work, occasional travel within the United States, lifting up to 25 lbs, and other physical requirements as described.