Senior Clinical Research Associate Resume Example Inventiv Health

SENIOR CLINICAL RESEARCH ASSOCIATE

OBJECTIVE

Dedicated Senior Clinical Research Associate with more than 6 years of experience. Broad background in clinical trials management of phase I/II/III trials in various indications including the implementation of study protocols, monitoring of sites and on-site data management and collection. Significant expertise in managing good relationship with the site to aid success of the study.

PROFESSIONAL SKILLS SUMMARY

Strong attention to detail with solid knowledge of GCP, ICH, FDA and other federal regulations.
Excellent interpersonal, presentation, written and communication skills.
Sound knowledge of human subject protection regulations, and general clinical research process.
Have a full understanding of AE/SAE reporting procedures, productions of reports, narratives and follow up of AE/SAEs.

Very familiar with medical terminology and clinical research concepts.
Multitasking: strong ability to work on several projects simultaneously.

Experienced using Electronic Data Capture (EDC), Interactive Voice Response Systems (IVRS) and Clinical Trial Management Systems (CTMS).
Strong Clinical Trial Computer Software experience including but not limited to Microsoft Office (Word, Excel and Power Point).

Skills

administrative support, Clinical Research, clinical trials, conferences, counseling, client, data collection, data entry, Delivery, documentation, email, English, focus, Forms, fundraising, GCP, IND, ink, Inspection, IVRS, letters, logistics, meetings, mentor, office, Negotiating, patient safety, personnel, policies, presentations, progress, protocols, quality, recruitment, reporting, safety, SOP, phone, travel arrangements

Experience

04/2014 to Current

Senior Clinical Research Associate inVentiv Health － Boston, MA

Conduct the clinical monitoring aspect of designated projects.
Perform clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection).
Collect regulatory documentation.
Perform qualification, initiation, monitoring and termination of investigational sites.
Assume the ability to meet the requirements of a CRA I and II with a high degree of proficiency and autonomy.
Shows solid understanding of therapeutic indications and study hypothesis.
Act as an independent CRA Coordinator on complex or multiple projects, CRA Coordinator on smaller projects.
Represent function in external client meetings and presentations such as investigator meetings and bid defenses as required.
May represent PAREXEL at professional meetings / conferences.
Function as mentor and role model for other CRA team members to ensure study specific training for CRAs.
Perform co-monitoring visits with less experienced CRAs or at problem sites as required.
Build relationships with investigators and site staff.
Participate in Investigator and other external or internal meetings as required.
Arrange on-site visits and logistics (e.g.
travel arrangements).
Perform on site visits in accordance with the monitoring plan.

Conduct on-site study-specific training (if applicable).
Perform site facilities inspection.
Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations.
Monitor and maintain ICH-GCP compliance.
Responsible for the completeness and quality of the on-site files.
Respond to site issue alerted from Clinical Monitoring Associate (i.e, non-responsive site,.
Protocol Deviations concerns, quality issues etc., items that require face to face interaction).
Collect SRP documents during QV and other visits as needed.
Establish site recruitment plan in collaboration with site during Qualification Visit; follow-up and update at Initiation Visit and Monitoring Visit.
Update all relevant tracking system on an ongoing basis.
Collaborate with CMA on site issues/actions.
Recognize out of scope activities, escalate and communicates to GRO Lead.
Generate visit/contact report in accordance with monitoring plan.
Code and scan Central File documents where applicable.
Ship relevant wet-ink signature documents to the Assistant or back to the site.
Attend audits / Regulatory Inspection if requested.

03/2011 to 02/2014

Clinical Research Associate II Medphase Inc － Philadelphia, PA

Perform Pre-study visits, Initiation visits, Interim Monitoring visits and closeout visits as required by the monitoring plan.
Provide protocol and related study training to assigned sites and track compliance to the protocol through-out the study providing re-trainings as necessary.
Establish regular lines of communication with sites to manage ongoing project issues and deliver on project team expectations.
Perform drug accountability to ensure adequate storage, dispensing, dosing and use of investigational products during monitoring visits.
Perform source document verification during visits to ensure that data collected is complete, accurate and that subjects meet all eligibility requirements.
Ensure proper documentation of non-compliance, ensuring that adequate re-trainings are provided to minimize excessive protocol deviations.
Performs on-site drug accountability and reconciliation. Verifies drug storage meets protocol and SOP requirements.
Serve as the primary liaison between the sponsor and the site for assigned protocols.
Identify issues at the sites during monitoring visits and either resolve issues with the site or escalate to the upper management as necessary.
Completes follow up letters from all visit types according to SOPs and completes reports to quality standards within company specified timelines.
Develops and maintains collaborative working relationships with clinical investigative sites.
Track safety issues through-out the study ensuring proper management, documentation and reporting of Adverse Events, Serious Adverse Events and IND safety reports.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
Serve as the main resource for the site and answer questions if applicable, or identify proper resources where necessary to resolve issues raised by sites.
Prepare and submit reports from study visits, Retrieve Case Report Forms (CRFs)/electronic Case Report Forms (eCRF) and Data Clarification Forms (DCFs) for submission to the sponsor.
Provide routine progress report on site activities to the study team via email, phone and during project team meetings.
Serve as a mentor to new hires and other CRAs in need of guidance.

Education and Training

B.Sc: Radiation Therapy Howard University － Washington D.C Radiation Therapy Deans List

A.A degree: General studies and pre Prince Georges Community College － Largo, Maryland General studies and pre

LANGUAGES

English: Fluent.

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Senior Clinical Research Associate Resume Example

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