Clinical Research Associate II Resume Example Inventiv Health Clinical

CLINICAL RESEARCH ASSOCIATE II

Summary

Accomplished clinical research professional with more than 4 years' experience in managing and monitoring multiple site simultaneously in fast-paced clinical environments. Analyze industry trends and standards to deliver relevant information to management to improve study data quality, human subject safety, and clinical trial purity. High performing clinical associate able to inspire multi-cultural teams to achieve outstanding results. Open and clear communicator at all levels with demonstrated disciplined execution of applicable clinical research regulatory requirements.

Highlights

Four years of experience as CRA in the Pharmaceutical and Research Industry
Proficient in MS Office Suite, Electronic Data Capture (EDC) systems (Medidata Rave & Inform), CTMS (Impact & Right Track II) and EMRs
Ability to travel 80% of the month

Skilled in researching, organization, coordinating, managing, quality trip reporting, and problem resolution
Trained staff on study protocols and handling procedures during site initiation visits
Experience in Phases I, II, and III clinical trials

Therapeutic Experience

Cardiovascular: Hypertension
Ophthalmology: Glaucoma
Infectious Disease: Pneumonia

Professional Experience

Clinical Research Associate II, 03/2013 to Current Inventiv Health Clinical

Lead all assigned clinical monitoring/site management from collaboration on site selection to study close-out and assured compliance with local regulations, Code of Federal Regulations (CFR)/International Conference of Harmonization (ICH) and Good Clinical Practice (GCP) guidelines and company/sponsor SOPs.
Critically evaluates adequacy of investigator sites (qualification, facilities equipment and performance)
Effectively plan and conduct site initiation visits (SIV), monitoring visits (MV), and close-out visits (COV) for investigator sites.
Maximize operational efficiency by training all assigned sites' staff to be compliant with requirements of the study protocol, informed consent process, data collection requirements/tools. Serious Adverse Event (SAE) reporting requirements, Investigational Product (IP) management, and bio sample management.
Ensure the effectiveness of tasks carried out for onsite/remote monitoring including but not limited to source document review (SDR), and source document verification (SDV) for the integrity of data on case report forms (CRF/eCRF), and review of the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconcile contents of the ISF with the Trial Master File (TMF).
Maintains awareness of key study performance indicators of own sites, site performance metrics with guidance and, creates and implements action plans for sites not meeting expectations.
Maintains, update, and track information within the deployed Clinical Trial Management System (CTMS).
Completes and submits accurate and timely visit reports in accordance with SOP or Sponsor requirements as agreed in the scope of work.
Applies query resolution techniques remotely and onsite, and provide guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
Participates in global conference calls and meetings to review progress of ongoing clinical trials.
Performs other work-related duties as assigned.

Clinical Trial Assistant, 04/2010 to 03/2013 Inventiv Health Clinical

Provided clinical operations support within Clinical Pharmacology to implement and manage study activities from study start-up to close-out of Trial Master Files (TMF).
Assisted in the preparation, management, and organization of assigned clinical studies.
Collected, reviewed, and maintained tracking of study related regulatory and financial documents from the sites.
Maintained a study regulatory document tracker, forwarded documents for imaging and storage, copy of the current study sites and vendor contracts.
Tracked and assisted with processing of site and vendor payments.
Prepared protocol review slides and subject diaries as needed.
Participated in the Electronic Data Capture (EDC) process, including review of eCRF data, Lab listings and User Acceptance Testing.
Assigned to track enrollment and study status information under the guidance of the Clinical Operations Specialist.
Supported and corresponded with investigative sites to identify site specific needs like ordering study drug and other related supplies.
Actively participated in team meetings and, prepared documents and files, and distributed the meeting agendas and minutes for committees.
Provided input and support in the development and distribution of the site communication.
Organized and maintained CRO list for clinical pharmacology studies and submitted safety letters to central IRB.
Generated reports in various applications to assist the Clinical Scientist to perform clinical data review.
Provided administrative support to managers/group as assigned and assisted with administrative team support like project start-up tasks' creation and maintenance of project files, periodic distribution of AE listings; and shipping information supplies to multiple sites.
Hands on experience with regulatory documents including eCRFs, ICFs, FDAs, and 1572.
Co-ordinated and checked incoming documents from sites; reviewed with checklist; ensured documents meets requirements in advance for further level review in conjunction with operations team member.

Education and Training

Bachelor of Science: US Equivalent Yaba College of Technology － Lagos, Nigeria

Professional Development Training (Inventiv Health Clinical): GCP Training 2013

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Clinical Research Associate II Resume Example

Resume Score: 85%