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
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Work History
May 2017 - CurrentCarolina , RI
Senior Clinical Research Associate / Inc Research Inc
- 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 2017Hobbs , NM
Clinical Research Associate II / Danaher
- 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 2015New York , NY
Clinical Research Associate I / Covance
- 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 2014Bronx , NY
Study Coordinator / Albert Einstein College Of Medicine
- 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
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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