CLINICAL RESEARCH ASSOCIATE - CRA
Location: Rockville Maryland
Description: ACCELOVANCE is presently looking of CLINICAL RESEARCH ASSOCIATE - CRA right now, this job will be placed in Maryland. Further informations about this job opportunity please read the description below. CLINICAL RESEARCH ASSOCIATE
CRA
Rockville , MD Chicago, IL Raleigh, NC West Palm Beach, FL Regional
Position Description:
The Clinical Research Associat! e (CRA) is a key member of the project team responsible for managing site communication s as well as planning and implementing all activities required to conduct and monitor complex clinical trials and ensures that Good Clinical Practices (GCP) are followed. Conducts site visits pre-study, at study initiation, at regular intervals during the study and at study closeout. Monitors investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary. Represent Accelovance in the medical research community and develops collaborative relationships with investigative sites and client company personnel.
Responsibilities Include:
- Participates in the identification of potential investigators and clinical sites, conducts prestudy site visits, collects and reviews data, and prepares evaluative reports; participates in the final selection of investigators andstudy sites
- Perform in-house ! and on-site monitoring activities for multiple investigational! sites in accordance with designated project assignment s
- Assists in the identification of centralized services such as clinical laboratories; assesses qualifications and experience in relation to proposed research activities, and participates in final selection
- Assists with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools; participates in the establishment of baseline parameters andedit check specifications c , and in the development of subject tracking systems
- Conducts clinical trial site initiation visits; advises and trains site personnel on sponsor and regulatory requirements for study conduct; participates and/or conducts site meetings and multicenter investigator meetings and prepares reports
- Conducts site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accor! dance with state and federal regulations, guidelines and policies
- Reviews on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required
- Ensures appropriate transmission of clinical case data to the data management centers; reviews case report queries and problems, and clarifies and/or obtains changes to data as appropriate
- Assists in the termination of clinical studies by identifying items and issues for review and/or follow-up; assembles necessary documents, conducts site termination visits to include test article reconciliation and disposition, review of completeness and accuracy of files, and retrieval of relevant codes and documents; prepares study termination reports.
- Maintain SOPs, GCPs, ICH, clinical and regulatory training.
- With each project,! become educated on the indication and therapeutic area to train and be! a resource to the site personnel.
- Manage a travel schedule across multiple sites within a project or across projects, allowing time for administrative duties.
- Performs other job-related duties as assigned
- Requires a BS or MS in a scientific or health care field (e.g., nursing, pharmacy, physician's assistant)
- Demonstrated the ability to manage multiple tasks
- Two to five years of direct hands on experience in the pharmaceutical i ndustry including relevant clinical research experience
- Demonstrated strong ability to work successfully in a team environment requiring matrix management skills
- Knowledgeable in all aspects of the Federal (FDA) regulations and requirements governing the conduct of clinical trials including, but not limited to, GCP and ICH requirements
- Demonstrated ability to make effective presentations in public settings
Send resume today to join our fast growing team to:
Attn: Human Resources Accelovance
2275 Research Blvd, Ste 700
Rockville, MD 20850
(Fax) 240-238-4901
career@accelovance.com
www.accelovance.com
Accelovance is an equal opportunity employer.
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If you were eligible to this job, please email us your resume, with salary requirements and a resume to ACCELOVANCE.
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This job starts available on: Fri, 14 Jun 2013 00:54:41 GMT