Monique Terry
Atlanta,GA
Summary
Detail-oriented Clinical Research Associate well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking and standard operating procedures.
Overview
19
19
years of professional experience
Work History
Principal Clinical Research Associate
PPD, Part Of Thermo Fisher Scientific
12.2020 - Current
- Maintains site monitoring schedules to facilitate effective communication with members of clinical team.
- Reviews clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducts initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Identifies areas for process improvement within clinical trials, implementing changes to enhance overall project efficiency and quality.
- Liaise with clinical project leader to effectively resolve study-related issues.
- Collaborate with clinical staff and other healthcare professionals to support clinical trial data accuracy.
SENIOR CLINICAL RESEARCH ASSOCIATE
PAREXEL
10.2018 - 12.2020
- Lead the quality and delivery activities during the start-up phase and ensure assigned sites are audit and inspection ready.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Communicated project status toproject management verbally and through technical documentation and presentations.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
SENIOR CLINICAL RESEARCH ASSOCIATE
PRA Health Sciences
09.2015 - 10.2018
- Implemented and monitored clinical trials to ensure sponsor and investigator obligations were met and compliant with applicable local regulatory requirements and ICF guidelines
- Performed source document verification and query resolution in a timely manner and oversees drug accountability
- Visited leader assigned to assess the knowledge and competency of individuals performing clinical monitoring tasks
- Participated in global conference calls and meetings to review the progress of ongoing clinical trials
- Independently prepared and performed investigative site visits relevant to the phase of study (selection, initiation, monitoring or site closure) as specified in the project plan and monitoring guidelines.
CLINICAL RESEARCH ASSOCIATE II
Syneos Health (formerly Inventiv Health Clinical)
02.2014 - 09.2015
- Monitored (pre-study, initiation, routine, and close-out visits) at investigator sites for GCP compliance
- Recruited investigators for participation in clinical trials
- Obtained, reviewed for appropriateness, and process regulatory and administrative documents from investigative sites
- Reviewed and verified CRFs and other clinical data, in-house, for completeness and accuracy; generate queries
- Resolved queries of CRF data with study site personnel
- Reviewed Tables and Listings generated from study data.
CLINICAL RESEARCH ASSOCIATE II
PRA Health Sciences
09.2010 - 01.2014
- Monitored (pre-study, initiation, routine, and close-out visits) at investigator sites for GCP compliance
- Obtained, reviewed for appropriateness, and process regulatory and administrative documents from investigative sites
- Oversaw drug accountability and safety investigative sites
- Reviewed and verify CRFs and other clinical data for completeness and accuracy and generate queries
- Performed query resolutions and resolved queries of CRF data with study site personnel
- Review tables and listings generated from study data
- Mentored newly hired Clinical Research Associates.
CDA II, CRA I, CDA I
Kendle International
05.2005 - 09.2010
- Reviewed and processed clinical trial data to ensure complete accuracy, timeliness and consistency of clinical databases
- Performed CRF tracking, review, and validation of data updates
- Effectively work as collaborative liaison to supply consistent clinical data feeds to support business needs of CRA and contracted trial sponsors
- Implemented and monitored trials to ensure sponsor and investigator obligations were met and compliant with applicable regulatory and ICH guidelines
- Effectively worked as a collaborative liaison to supply consistent clinical data feeds to support business needs of CRA and contracted trial sponsors.
Education
Bachelor of Science in Sociology -
University of North Alabama
Florence, ALSkills
- Site Management
- Detailed documentation
- ICH Guidelines
- Coordinating site operations
- Informed Consent Process
- Completing regulatory documents
- Clinical Data Management
- Team Training
Therapeutic Areas Of Expertise
- Cardiovascular Risk, III, 1.5 years, Clinical Monitoring
- Oncology-Leukemia, I, 1.5 years, Clinical Monitoring
- Oncology-Cancer Pain, III, 1 year, Clinical Monitoring
- Oncology- Solid Tumors NSCLC, Breast Cancer, Pancreatic, I, II, III, IV, 4 years, Clinical Monitoring
- Oncology- Lymphoma, I, II, III, 3 years, Clinical Monitoring
- Gastrointestinal- Crohn's disease, II, 2.5 years, Clinical Monitoring
- Infectious Disease-COVID-19, Flu, II-III. 3.5 years, Clinical Monitoring
Study Design Experience
- Dose Escalation
- Double Blind
- Placebo Controlled
- Parallel
- Product Registry
- Expanded Access
- Open Label
- Pharmacoeconomic
- Proof of Concept
- Randomized Controlled
PROFESSIONAL AFFILIATION
SOCRA
Timeline
Principal Clinical Research Associate
PPD, Part Of Thermo Fisher Scientific
12.2020 - Current
SENIOR CLINICAL RESEARCH ASSOCIATE
PAREXEL
10.2018 - 12.2020
SENIOR CLINICAL RESEARCH ASSOCIATE
PRA Health Sciences
09.2015 - 10.2018
CLINICAL RESEARCH ASSOCIATE II
Syneos Health (formerly Inventiv Health Clinical)
02.2014 - 09.2015
CLINICAL RESEARCH ASSOCIATE II
PRA Health Sciences
09.2010 - 01.2014
CDA II, CRA I, CDA I
Kendle International
05.2005 - 09.2010
Bachelor of Science in Sociology -
University of North Alabama