Resume Details Flashcards
1
Q
Therapeutic Area of Experience
A
Oncology CNS Infectious Disease Medical Device Respiratory
2
Q
Oncology
A
Solid Tumor Leukemia Melanoma Lymphoma Breast Cancer
3
Q
CNS
A
Schizophrenia
Parkinson Disease
Multiple Sclerosis
Bipolar Disorder
4
Q
Infectious Disease
A
Flu
5
Q
Medical Device
A
Cardiac Pacemakers
Catheters
6
Q
Respiratory
A
Bronchitis
Asthma
7
Q
Job 1
A
Clinical Research Coordinator
Feb 2017 to Jan 2018
Winship Cancer Center Columbus, Ohio
8
Q
Winship Cancer Center
A
- Assisted with assessing patient eligibility to participate in specified clinical research protocols; may recruit, interview and enroll patients
- Obtained informed consent and ensured consent process was administered in compliance to regulatory and sponsor requirements
- Participated in the collection, processing & evaluation of imaging studies performed at submitted sites
- Performed Quality Assurance and communicates with performing sites, study chairs, investigators and trial staff
- Supported reader assessment by local and remote readers
- Participated in evaluating imaging data for compliance related to protocol; assisted with collecting, extracting, coding, and analyzing clinical research data
- Generated reports and reviews to ensure validity of data
- Supported activities to ensure compliance with all applicable policies
- Participated in activities to develop new research protocols and contributed to establishment of study goals to meet protocol requirements
9
Q
Job 2
A
Clinical Research Associate I/II
Syneos Health
Jan 2018-Feb 2021
Atlanta, GA
10
Q
Syneos Health
A
- Conducted site selection visits to ensure that the facilities and staff are adequate for conducting studies
- Conducted site initiation visits to ensure sites and study staff are adequately trained and prepared to conduct the study
- Verified that the research site investigator(s) and study personnel are conducting the study according to the study protocol, GCPs, and regulatory requirements to ensure protection and ethical treatment of human subjects
- Performed monitoring activities per the monitoring plan (e.g. verification of source documents, informed consent review, site communications, follow up on data anomalies, etc.)
- Reviewed accuracy and completeness of site records (i.e., essential documents, query resolution, and other study documents)
- Ensure complete reporting and proper documentation of monitoring activities
- Performed other duties as assigned
11
Q
Current Job
A
Senior Clinical Research Associate
Denver, CO
Feb 2021-Current
Syneos Health
12
Q
Syneos Health Current
A
- Coordinates the activities of investigators to ensure compliance with the overall scientific study objectives
- Ensures accurate and complete study management/data collection and transfer to data management
- Ensures site compliance with regulations and study protocol
- Conducts monitoring visits PSST, SIV, IMV and COV to confirm subject safety and IP accountability
- Monitors the sites and provides technical assistance
- Ensures that investigator site files are assembled appropriately and that all required documentation is in place, tracked and reconciled on a regular basis against the TMF files
- Supports in mentoring less experienced CRAs on project or department tasks and requirements
- Under moderate guidance; plans and prepares studies
- Reviews study protocols, reports and manuscripts
- Contributes technical and clinical operations expertise for these documents
13
Q
Technology
A
EDC: Rave and Inform
CTMS: Impact
TMF: VeevaVault
IWRS: Suvoda and Endpoint
14
Q
Skills
A
- Over 5 years of clinical research experience
- Strict attention to detail
- Experience working in phases I, II and III clinical trials
- Ability to perform up to 80% of nationwide travel
- Exceptional organization skills
- Strong written and verbal skills
- Excellent knowledge of ICH and GCP
- Identified as a top performing CRA
