Clinical Research Associate 3

Grifols SA•Raleigh, NC

49d

About The Position

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. 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.

Requirements

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.
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.

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.
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.
Leads the activities of the CRA team to meet the study objectives. Identifies and addresses weaknesses in individual or team performance. Assists study manager in overall study management. Monitors and/or co-monitors as required with CRO and CRA staff to insure study integrity and compliance. Develops ICF templates and reviews study specific ICF(s). Participates in CRF development and completion. Reviews monitoring reports and QA reports from site visits. Manages clinical study set-up and follow-up study activities through tracking and review. Assists in the development of the clinical risk management plan. Develops, implements, and maintains monitoring plan for studies run internally. Coordinates and presents at investigator meetings, kick-off meetings, etc. Interacts as functional lead with data management, safety, regulatory personnel, and other functional groups. Leads team members in reviewing data listings in reviewing data listings and writing queries. Tracks and manages the distribution of study drug and clinical supplies. Contributes to development of site budget.