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Senior Clinical Research Associate Resume Example

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SENIOR CLINICAL RESEARCH ASSOCIATE
Professional Summary

A professional Sr. CRA with over 6 years of experience in clinical trials. Detail-oriented and driven clinical research professional able to coordinate operations, manage sites and draft detailed reports. Experience includes all phases (I-IV) of drug development. I adapt quickly to a fast-paced environment and identify problems to successfully recommend and implement solutions. Desiring a challenging new role at a CRO or Pharma that provides the right environment.

Skills
  • Clear, concise, and effective written and verbal communicate skills
  • Strong organizational, computer and problem-solving skills
  • Thorough knowledge of FDA and GCP principles and regulations
  • Strong analytical, research and trial preparation skills
  • Detail-oriented, fast learner and good listener
  • Vast with the EDC systems (Medidata Rave, Inform, OC RDC) and CTMS (Medidata CTMS, IMPACT)
Work History
May 2017 - CurrentWilmington, NC
Senior Clinical Research Associate / PPD
  • Reviewed data queries, assists sites with query resolution and followed up on outstanding queries.
  • Reviewed data status reports and follow-up with sites regarding missing and/or late data.
  • Observed for trends and coached sites to improve performance.
  • Conducted site selection, initiation, monitoring, and close-out visits for research sites according to the monitoring plan, PPD and sponsor SOPs, ICH GCP guidelines and applicable regulations.
  • Participated in investigators meetings.
  • Prepared site visit reports and follow-up letters to the investigators.
  • Built productive relationships with investigators and site staff to achieve study objectives, including patient recruitment targets.
  • Performed source data and patient's records verification, ensures on-site study drug storage, dispensing, and accountability, data collection, and regulatory document collection is adequate.
  • Reviewed specified patient data and source documents.
  • Appropriately reported safety concerns, protocol deviations, and/or unexpected data trends.
  • Primary contact for study site personnel.
  • Provided training to site personnel.
  • Tracked and reports progress of study sites.
  • Responsible for quality data from study sites.
  • Ensured appropriate source documentation, training, and accurate transcription of data into the study Case Report Form (CRF) as evidenced by minimal data query rates.
  • Ensured timely reconciliation of data queries and implementation of process improvement/corrective action when needed.
  • Participated in team meetings.
  • Coordinated, assembled, and shiped study related supplies as needed.
  • Assisted with creation and review of study tools/documents.
  • Maintained awareness of overall development in the field of clinical research based on current literature, attendance at professional meetings, continuing education, etc.
Jul 2015 - May 2017Wilmington, NC
Clinical Research Associate II / PPD
  • Acted as a member of the project team with the goal to contribute towards efficient management of trials.
  • Responsible for all aspects of site management as prescribed in the project plans.
  • Ensured the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
  • Ensured the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
  • Ensured the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
  • Monitor data for missing or implausible data.
  • Performed the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to PPD travel policy.
  • Prepared accurate and timely trip reports.
  • Managed small projects under direction of a Project Manager/Director as assigned.
  • Organized and made presentations at Investigator Meetings.
  • Interacted with internal work groups to evaluate needs, resources and timelines.
  • Assisted with training, mentoring and development of new employees, e.g.
  • Co-monitoring.
  • Perform other duties as assigned by management.
Oct 2014 - Jul 2015Somerset, NJ
Clinical Research Associate I / INVENTIV HEALTH
  • Fulfilled general on-site Monitoring responsibilities.
  • Prepared accurate and timely trip reports.
  • Identified and completed follow-up of SAEs at study site for which he/she is responsible.
  • Independently performed CRF review, query generation and resolution against established data review guidelines on CTMS.
  • Confirmed study staff conducting the protocol have received the proper materials, instructions and training to safely enter subjects into the study and complete the protocol requirements.
  • Ensured subjects protection by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
  • Ensured the integrity of the data submitted on CRFs or other data collection tools by careful source document review.
  • Ensured that Site Regulatory Documents are complete and current throughout the duration of the trial.
  • Performed Project Plans related to Clinical Monitoring responsibilities.
Jun 2013 - Oct 2014Houston, TX
Study Coordinator / MD ANDERSON CANCER CENTER
  • Possesses a broad-based knowledge of FDA regulations as well as ICH/GCP guidelines.
  • Facilitates the flow of information between principal investigators, study sponsors, and IRB.
  • Exhibits exceptional interpersonal skills and work ethic.
  • Ensures the timely and accurate conduct of clinical trials in accordance with FDA, ICH, and GCP guidelines.
  • Responsible for IRB submissions, i.e.
  • Protocol changes, ICF amendments, continuing renewal, and other relevant regulatory requirements for more than 200 IRB studies.
  • Interfaces with study sponsors, monitors and reports SAEs; resolves study queries.
Education
May 2012
BACHELOR OF SCIENCE in Computer Information Systems, Health InformationDeVry University
THERAPUETIC EXPERIENCE

Oncology: Breast, Ovarian, Colon, AML, CLL, Melanoma

CNS: Alzheimer's Disease, Intractable Pain Disorder

Endocrinology: Diabetes Mellitus

Medical Device: Valvular Heart, Pulse Oximeter, Glucometer

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Resume Overview

Companies Worked For:

  • PPD
  • INVENTIV HEALTH
  • MD ANDERSON CANCER CENTER

School Attended

  • DeVry University

Job Titles Held:

  • Senior Clinical Research Associate
  • Clinical Research Associate II
  • Clinical Research Associate I
  • Study Coordinator

Degrees

  • BACHELOR OF SCIENCE in Computer Information Systems, Health Information

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