Clinical Research Associate
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Our client is the biotech division of a world-leading medical device company that has developed a reputation for successfully bringing complex products to market in a variety of therapeutic areas. The company has strong financials, an experienced management team and a loyal customer base. They have developed an industry-wide reputation for a positive work environment and an aggressive training program that ensures employees are up-to-date on current trends and best practices. This is a strong opportunity for an executive that wants to put their drive and initiative to work!
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Responsibilities
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1) Oversee the conduct of clinical studies
2) Perform on-site monitoring activities to ensure assigned clinical studies are conducted as per approved protocols, applicable regulations, work instructions, guidelines and/or policies
3) Develop and liaise with external physicians and clinical investigators, CROs, affiliated hospitals, government hospitals, etc. to initiate and expedite clinical studies on products that have IDE, IND requirements or special provisions (as required by the FDA for 510(k) approval)
4) Contact and recommend qualified investigators to perform studies, prepare exhibits and provide scientific and medical consultations for any phase of development studies
5) Review cases with investigators
6) Determine and monitor time schedules and issue status reports
7) Assist with designing, development and monitoring of clinical evaluation projects and associated monitoring plans
8) Train investigators and associated personnel on the conduct of the clinical trials they are involved in
9) Perform pre-study site qualification visits to evaluate adequacy of site, Investigator and designated site personnel
10) Participate in the site nomination process
11) Perform closeout visits as well as other activities associated with the completion of a clinical trial
12) Review records to ensure clinical studies are conducted in compliance with currently approved protocols, applicable regulations, work instructions, guidelines and/or policies
13) Evaluate site capability to deliver the contractually agreed to number of patients and high-quality data and make recommendations for inclusion in the clinical trial
14) Ensure site compliance with the clinical study protocol, documentation and resolution of monitoring issues, safety, investigational product accountability, preventative/corrective action plan implementation to prevent recurrences
15) Perform ongoing monitoring visits at assigned investigational sites to verify that the rights and well being of human subjects are protected as well as the reported clinical data is accurate, complete and verifiable from source documents
16) Assist in query writing and resolution process (as required)
17) Ensure study documentation is accurately and properly maintained at the investigational sites
18) Provide on-site training of investigators and other site personnel
19) Prepare and submit timely, accurate and complete monitoring reports
20) Collaborate with cross-functional teams in evaluating safety data, investigational product tracking, compliance, data management, etc.
21) Communicate with internal Clinical Study Team to ensure adherence to timelines for site monitoring and clinical study activities
22) Maintain a high level of professional expertise through familiarity with clinical literature and participation in Clinical Team meetings
23) Communicate with clinical sites to expedite the exchange of information and ensure that clinical studies are kept on schedule
24) Coordinate the organization of study files, inventory and all related study materials
25) Assist (occasionally) with the development and/or maintenance of the clinical infrastructure such as the drafting or reviewing Best Practices and Work Instructions
26) Prepare materials and deliver presentations (occasionally) at Investigator and general clinical meetings
27) Assist with preparing progress reports (occasionally) for clinical studies
28) Attend and/or perform site initiation visits as needed
29) Assist (occasionally) with preparation of documents for obtaining product or study approvals such as IDE application, IND application, FDA reporting, etc.
30) Participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed
31) Assist (occasionally) with the financial aspect of the clinical trial including contracts, budget negotiations and preparations (as needed)
32) Work with the clinical management staff for developing, approving and distributing study-related documents including CRFs, study protocols, study manuals, etc. to investigational sites and review committees (as applicable)
33) Assist (occasionally) with supplying content for mass communications, newsletters and study coordinator training/conferences, etc., as needed
34) Ensure that clinical sites have adequate supplies of product and material to effectively conduct the study
35) Assist in various projects as assigned |
Requirements
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1) Bachelor’s degree (Life Science or scientifically related field preferred) or RN/BSN degree with 2 – 4 years of experience in clinical trials and site coordination (industry/institutional setting preferred)
2) Orthopedic or neurological experience preferred
3) Pharmaceutical experience preferred as well as project and general budget expertise
4) Knowledge of FDA regulatory requirements
5) Knowledge and general application of medical terminology, FDA IDE regulations and clinical study and data management process
6) Proficiency with MS Office (Word, Excel and PowerPoint)
7) Ability to successfully prioritize multiple tasks as well as take ownership and workflow initiative
8) Ability to work independently in setting and following timelines and deliverables
9) Excellent communication skills (oral and written)
10) Good organizational, presentation and time-management skills
11) Strong analytical skills and ability to solve problems through analytical reasoning
12) Ability to apply advanced reasoning and problem-solving skills to complex situations
13) Commitment to teamwork and superb work ethics
14) Detail-oriented with ability to be flexible
15) Willingness to travel – extensive overnight travel (up to 75%)
Applicants are encouraged to apply directly by going to: http://www.sterlinglifesciences.com/jobs/lifesciences-jobs-03298.html |
Additional Job Information
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