Clinical Research Associate
Location: Cleveland, Ohio
Description: Syntactx is at present recruited Clinical Research Associate right now, this vacancy will be designated in Ohio. More details about this vacancy opportunity kindly read the description below.
What began as a family business has quickly grown into a leading Contract Research Organization that has maintained the integrity, ethics, and values upon which it was founded.
Syntactx delivers the highest quality clinical research services based on a well -defined strategy, collaboration, and transparency, thereby reducing time to execution and minimizing the overall risk of a project. Clients benefit from our agility, decades of experience, on-staff physicians, and excellent relationships.
Ranked #241 on the 2015 Inc. 500 list of the fastest-growing private companies in America, Syntactx is headquartered in New York City, has offices in Belgium, and partners across the United States and in Europe.
CANDIDATES MUST ALSO HAVE A MINIMUM OF 2 YEARS OF FIELD MONITORING EXPERIENCE
GENERAL SUMMARY:
Under the direction of the Associate Director of Clinical Operations/Senior Project Manager, the CRA has responsibility for the comprehensive monitoring of clinical study sites. This includes the responsibility to verify that the rights and well-being of human subjects are protected and that the trial is conducted in compliance with GCP and with all applicable regulatory requirements. The CRA will also assist with other project management and site management activities, as needed. Travel is required.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Coordinate and manage clinical site monitoring responsibilities for assigned projects, with guidance from the Project Manager and/or the Associate Director of Clinical Operations.
- Perform clinical site monitoring duties in accordance with contractual agreements, department guidelines, SOPs, applicable international, Federal and State regulations, and ICH Guidelines.
- Serve as a liaison to internal and external partners and to the project core team (project manager, principal investigator, and other functional group key representatives).
- Oversee trial-related training and any performance concerns of the clinical trial sites. Maintain awareness of level of performance and training needs; provide ongoing input to the project manager for the development of individual training pl ans.
- Manage the development and maintenance of clinical trial documents, processes and systems according to trial-specific scope of work and budget, and possess the skills and leadership to perform these activities on an independent basis.
- Assess the suitability of potential investigative sites through telephone screening interviews, regulatory document review and evaluation of clinical trial information.
- Follow established study-specific guidelines for the collection of clinical data and/or administration of clinical trials.
- Travel as required inside and outside of the United States to accomplish responsibilities.
- Conduct site qualification visits to determine adequacy of facilities and staff, patient recruitment and retention potential, ability to comply with regulatory requirements, and overall interest and commitment of the principal investigator to conduct and complete the planned clinical study.
- Conduct site initiation vi sits for the purpose of training site personnel on the protocol, study procedures, patient recruitment and retention requirements, regulatory requirements, case report form completion and retention requirements, product accountability procedures, adverse event reporting, and overall site management.
- Conduct monitoring visits to ensure the compliance and the integrity of clinical data through review of CRFs, source documents, medical records, and regulatory documents.
- Track study site activities, including but not limited to:
- Screening and enrollment
- Collection and review of site essential documents for completeness
- Trial Master File Maintenance
- Study site progress and issues
- Ensure that adherence to industry standards and regulatory requirements, including but not exclusive to Good Clinical Practices (GCP), is maintained via the documentation of all activities. Ensure that Standard Operating Procedures are followed, and that all aspects of the study activities are conducted in accordance with the ethical and professional standards and established policies of the Company
- Attend external and internal meetings such as vendor meetings and internal meetings * Communicate with sites and sponsors through verbal and written correspondence, summarizing the overall site function, any deficiencies, and corrective action if needed. Follow-up with sites until deficiencies are resolved.
- Provide all job-related progress reports/technical reports as requested.
- Performs related duties as required and assigned.
MINIMUM QUALIFICATIONS:
- Work requires graduation from a 4 year accredited bachelor’s degree program or work as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist.
- Willing to travel 50% or more depending on trial demands
- Knowledge of devices, with a background in cardiovascular trials is a plus.
- Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification strongly preferred.
- Must be able to work independently following a brief period of specific technical training.
- Must possess excellent verbal and written communication skills.
- Strong organizational skills with attention to detail.
- Must demonstrate basic computer proficiency.
- Demonstrate a high degree of personal and professional integrity.
WORKING CONDITIONS/PHYSICAL DEMANDS:
Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Work Environment: May work from home when not working at sites, with approval of manager. Study sites environment; may require working evenings and weekends. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to manipulate objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear. Work may involve long periods of standing and/or computer usage. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment can be moderate.
GENERAL INFORMATION:
The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and skills required. The employee must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple, competing tasks and demands and to seek assistance as appropriate.
Job Type: Full-time
Experience:
- Device Trial: 2 years
- Clinical Field Monitor: 2 years
Education:
- Bachelor's
Loc ation:
- Cleveland, OH
License:
- ACRP Certification
Required work authorization:
- United States
.
If you were eligible to this vacancy, please deliver us your resume, with salary requirements and a resume to Syntactx.
See service industry resume sample sample here.
Interested on this vacancy, just click on the Apply button, you will be redirected to the official website
Apply Clinical Research Associate Here
This vacancy will be started on: Tue, 15 May 2018 16:01:44 GMT
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