Kendle International Inc. (Nasdaq: KNDL) is a leading global clinical research organization providing the full range of early- to late-stage clinical development services for the world's biopharmaceutical industry. Our focus is on innovative solutions that reduce cycle times for our customers and accelerate the delivery of life-enhancing products to market for the benefit of patients worldwide.
As one of the world’s largest global providers of Phase I-IV services, we offer experience spanning more than 100 countries, along with industry-leading patient access and retention capabilities and broad therapeutic expertise, to meet our customers' clinical development challenges.
Post: Clinical Research Associate - I
Job Description:
• Acts as site liaison to develop and maintain rapport with study site personnel, vendors, sponsors and INC Research team members.
• Assists with the development of materials for and performs regulatory document collection and tracking (where applicable), technical support, pre-study, study initiation, monitoring, site management, and close-out activities via telephone while adhering to all applicable regulatory and Standard Operating Procedures (SOPs) and Project Plans.
• Performs in-house site support activities, researching and responding to various site inquiries (study materials, protocol, systems use, study documents, CRF conventions, queries, payments, etc.), appropriately tracking and documenting these interactions.
• Assists in the development of and maintains study documents such as CRFs and CRF completion guidelines, mailing/faxing materials, newsletters and telephone scripts
• Participates in the preparation and coordination of investigator meetings or other investigator site training and attends investigator meetings as requested.
• Performs quality control (QC) activities across all areas of project responsibilities.
• Adheres to safety reporting requirements
• Adheres to a schedule of project-related communications (e.g., calls, mailings, reports) and activities and effectively employs technology for tracking.
• Attends and presents PCS status at project team and client meetings as requested
• Establishes working relationships with other INC Research personnel to ensure that study-specific documentation is retrieved, filed and maintained in a high quality, timely quality manner.
• Anticipates/identifies potential problems and implements corrective actions. Suggests and implements alternative solutions to problems with study timelines, schedules, resources, etc. to department or study management.
• Performs the following data management activities: direct data entry from telephone interviews, CRF routing, data reviewing, querying, and updating.
• Assists in the development of patient enrollment strategies
• Manages telephone calls and e-mails generated by recruiting and advertising initiatives from the general public, potential patients, their families, or referring physicians and provides approved study information
• Provides support for study awareness, patient recruitment, and investigative site activities, including manning toll-free public call center and investigative site help lines. Serves as a central contact point for public inquiries regarding studies.
• Conducts outbound telephone calls per project requirements, including administration of patient assessment tools (e.g., Quality of Life (QoL) questionnaires, patient compliance surveys) and acquisition of study documents (regulatory documents, queries, etc.) and general site management.
• Prepares and distributes regular status reports
• When requested, provides support by assisting with limited monitoring activities on site
• Continues professional development in a manner that ensures increased industry knowledge.
• Executes other duties and assignments as requested for the overall performance of the department and the company.
Candidate Profile:
Education: AA/AS degree or equivalent a life sciences discipline is highly desired
Experience: At least 1 year of related industry experience. Previous practical experience with clinical research studies in a CRO, site setting, or pharmaceutical company preferred.
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Additional skills: Necessary attributes include: Strong organizational and leadership skills, excellent oral/written communication skills, proficiency with computer/software systems, ability to prioritize a diverse workload, and attention to detail with a focus on quality. Strong interpersonal, telephone communication and customer service skills and ability to work on a team or independently as needed. Familiarity with medical terminology a strong plus.
Additional Information:
Experience: 1 Years
Location: Wilmington, North Carolina - USA
Education: AA / AS - Life Sciences
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Job ID: 7853
End Date: 30th Oct., 2011
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