.

.

Mableton, GA ***** 352-***-**** adwyer@r.postjobfree.com

JOY STROUD

PROFESSIONAL

SUMMARY

A skilled senior clinical research associate with over 7 years of monitoring experience and a great track record of success in progressively responsible position in clinical environments. Experienced in monitoring multiple site locations, registration trials and regulatory inspection, clinical site evaluation, initiation, maintenance and close out visit in accordance with GCP and company SOP's while ensuring integrity of study data and following study timelines. Organized and dependable with a positive attitude and willingness to take on added responsibilities to meet team goals.

THERAPEUTIC

EXPERTISES

• Oncology: Breast cancer, Ovarian Cancer, Prostate Cancer and Solid Tumors.

• Cardiovascular: Hypertension.

• Medical Device: Pacemakers DDD, In vitro diagnosis.

• Infectious Disease: HIV/AIDS and Tuberculosis.

• Opthalmology: Glaucoma, Dry eyes, Diabetic Retonipathy, Uveitis. SKILLS • Excellent, presentation,

organizational and

interpersonal skills

• Proficient in the use of

electronic data capture

systems (EDC: Medidata

Rave, Inform, OCRDC)

• Clinical Trial Management

Systems (CTMS: Lotus &

Impact) and IVRS systems

• Electronic trial master file

(eTMF)

• Excellent written and

verbal communication

skills to express complex

ideas

• Sound knowledge of

Good Clinical Practices

(ICH-GCP) and FDA

regulations

• Conversant with the

design and review of Case

Report Form (CRF)

• Computer Skills:

Microsoft Office (Word,

Excel, Power Point,

Outlook)

Ee

.

.

WORK HISTORY SENIOR CLINICAL RESEARCH ASSOCIATE 08/2021 to Current IQVIA, Atlanta, GA

• Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.

• Reviews protocol violations and implement corrective measures such as training or retraining of site personnel per sponsor/ Company's SOP to prevent future occurrence.

• Escalates concerns and potential risks then document observations and recommendations to ensure prompt resolution of these concerns or issues in a timely manner.

• Ensures the study staff who will conduct the protocol have received the proper materials.

• Assists with training, mentoring and development of junior CRAs.

• Performs and coordinate trial process according to Protocol, ICH-GCP guidelines and SOP.

• Verifies CRF/ eCRF with the source data for consistency, generate and resolve data queries as required.

• Participates in Sponsor and Investigator initiation meetings.

• Ensures reports and training are completed and submitted in a timely manner.

• Ensures study supplies (lab kits) are available on site. IP accountability, inventory, security, dispensation, return and destruction (where applicable) are in compliance with protocol and site SOP.

• Ensures Adverse Events and Serious Adverse Events are reported according to protocol/ ICH GCP guidelines.

• Manages ISF and update CTMS with information and regularly communicate with the team on site.

• Performs Regulatory inspections, FDA audits and Sponsor related audits, working across couple of eTMFs to QC documents in preparation for regulatory inspections. CLINICAL RESEARCH ASSOCIATE II 11/2019 to 08/2021

IQVIA, Atlanta, GA

• Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.

• Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.

• Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.

• Supported development and delivery of department training to maximize success of clinical research.

• Traveled to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits to maintain and enforce regulatory compliance.

• Reviewed clinical data, source documentation, case report forms and investigative site regulatory files.

• Observed studies to safeguard continued effectiveness of the investigator, clinical site team and facility.

• Managed progress by tracking regulatory submissions, recruitment, case report form

(CRF) completion and data query resolution.

• Ensured adherence to study timelines and budgets

• Documented and reported clinical study progress and discussed potential opportunities and risks with respective project team members.

• Conducted all activities according to defined project-specific quality and performance standards as well as relevant standard operation procedures (SOPs), good clinical practices (GCPs) and local requirements.

• Reviewed participant eligibility and documentation of consent.

.

.

• Provided clinicians with information on how to properly conduct trials.

• Monitored the collection, accuracy, and integrity of regulatory documents in the site binder.

• Planed and assisted study start-up activities such as, creation and review of Laboratory Manual, Site Initiation Presentations, CRF Completion Guidelines and various forms, study tracking and management documents).

CLINICAL RESEARCH ASSOCIATE I 04/2017 to 11/2019

SYNEOS HEALTH

• Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.

• Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.

• Maintained site monitoring schedules to facilitate effective communication with members of clinical team.

• Followed drug storage procedures to comply with protocols and SOP requirements.

• Reviewed data queries and listings and worked with study centers to resolve data discrepancies.

• Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents, and data completion.

• Gathered and organized clinical trial documentation to meet rigorous standards for site approval.

CLINICAL RESEARCH COORDINATOR 07/2014 to 03/2017

Emory Clinical Research Centers

• Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.

• Collected data and followed research protocols, operations manuals, and case report form requirements.

• Gathered, processed, and shipped lab specimens.

• Followed informed consent processes and maintained records.

• Improved delivery of patient care through reviewing and implementing improvements to clinical approaches.

• Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.

• Worked with principal investigator and sponsors to facilitate daily trial activities and ensure compliance with research protocols.

• Entered data into the study specific EDC and site CTMS in a timely manner

• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.

• Collected, evaluated, and modeled collected data.

• Proved successful working within tight deadlines and fast-paced atmosphere. EDUCATION University of Lagos, Lagos, Nigeria

Bachelor of Science, Sciences.

Good Clinical Practice GCP (2023)

Contact this candidate