Clinical Research Associate (CRA) II, 07/2015
to Current PRA HEALTH SCIENCES – Alpharetta,
Conduct all activities according to the defined project-specific quality and performance standards as well as relevant SOPs, ICH/GCP, and local requirements Ensure awareness of project-specific quality and performance standards and ensure that these are adequately documented, communicated, and understood Actively participate in training sessions and workshops, including presenting reports from any conferences attended Assist in the development of patient recruitment strategy.
Attendance at Investigator Meetings.
Perform and document pre-study site evaluations, site initiations, regulatory document collection, interim monitoring and study close out visits in accordance with GCP, study-specific requirements, clinical monitoring plans, company SOPs, applicable regulatory requirements and defined quality and performance standards.
Ensure site IRB approval is current and all IRB documentation is in order.
Maintain site monitoring schedule and serve as the principal point of contact for investigational sites.
Document and report on clinical study progress, i.e.
patient recruitment and discuss potential opportunities and risks with respective Project Team members.
Ensure patient safety is maintained and informed consent procedures are carried out Provide training and update investigative site team of any changes in study conduct and documentation requirements.
Ensure continued acceptability of the investigator, clinical site team and facility.
Review clinical data, source documentation, CRF, and investigative site regulatory files.
Work closely with data management and site to resolve discrepancies.
Ensure investigational product accountability accuracy and oversee investigational product inventory.
Liaise with vendors such as central laboratories as required to ensure protocol adherence and ensure investigational sites have appropriate clinical supplies Meet with clinical study sponsor representatives, as requested.
Submission of routine monitoring visit reports and follow-up letters as per required timelines Ensure resolution of issues with investigative sites Attend meetings as assigned and report on actions.
Participate in educational activities and programs.
Maintain strictest confidentiality.
Work closely and effectively with all other department personnel to ensure appropriate communication and study conduct.
Assist other staff as requested and perform other related work, as needed.
Function as a mentor for team members.
Clinical Research Associate, 01/2013
to 07/2015 PRA HEALTH SCIENCES CRA – Alpharetta,
Conducted all forms of monitoring visits, including pre-study, initiation, routine, and final monitoring visits, in accordance with the protocol, local laws, ICH-GCP and SOPs.
Prepared accurate and timely visit reports from all monitoring visits.
Communicated effectively with both site personnel and management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
Developed and maintained good working relationship with investigators and study staff.
Maintained study tracking, in accordance with the demands of the study.
Performed data management activities, including in-house CRF review, query resolution, and resolves data discrepancies, dependent upon the study/sponsor arrangement.
Identified and processed Serious Adverse Events according to the procedures defined by the study team.
Also demonstrated a full understanding of the SAE reporting process.
Clinical Research Coordinator, 09/2011
to 01/2013 EMORY UNIVERSITY CRC – Atlanta,
Worked with Clinical Research Coordinator II/III to coordinate studies from start-up through close-out.
Reviewed familiarity with the sponsored protocols, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
Determined eligibility of and gathered consent materials from study participants according to protocol.
Assisted in developing recruitment strategies.
Interacted with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
Bachelor of Science (BSL): 1998 Excelsior College - Albany,
University of San Francisco School of Business -
Clinical research professional who uses a holistic and collaborative approach to problem solving with a strong commitment to the highest levels of quality and integrity.