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Job Details

Clinical Research Associate

Company name
Borough of Montvale, New Jersey

Montvale, NJ

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Job Description
Hello\r \rMy name is Sandeep Lakshmanan and I am a Senior Recruiter/Account Manager with ACT Consulting. We have an urgent contract opening for a Clinical Research Associate with our direct client in Montvale, New Jersey. Please take a moment to review the job description. If this is something you are interested in, please send a copy of your resume to or call me on 203-302-0562. Also, if you are not interested and know someone who may be a fit for this job, we do offer a competitive referral fee.\r\r\r12265-Clinical Research Associate\r6 months contract\rMontvale, New Jersey - 07645\r\r\rMANAGER NOTES:\r\r Certifications are preferred \r Experience with clinical study supervision, cosmetics and GMP \r Will review backgrounds from Pharma and Medical Devices\r Candidates must have experience with GCP compliance, cosmetic studies and strong attention to detail.\r\r\r\rJOB DESCRIPTION:\r \rTo be responsible for all aspects of allocated clinical studies in global Hygiene and/or Personal Care categories in accordance with SOPs and GCP compliance. \r\r\rScope: \r\r To assist Clinical Project Managers in all aspects of clinical studies including protocol development, study coordination, study report, monitoring and archiving. \r To lead CRO site qualifications and respond to/address site audits and CAPAs. \r To work in multi-functional project teams providing input on GCP compliance for cosmetic clinical studies. \r To negotiate costs and manage payments for clinical studies in remit. \r\r\r\rResponsibilities: \r\r To ensure that all protocols developed for cosmetic and OTC clinical studies address the business requirements and are fully compliant with relevant legal and regulatory requirements and SOPs. \r To ensure that all clinical studies are performed to the required timelines. \r To ensure that the relevant Hygiene Clinical SOPs are implemented for all clinical studies. \r To participate in Hygiene Clinical SOP revisions \r To effectively partner with assigned Statistician on providing analyses for robust clinical claim support. \r To provide clinical input to project risk assessments. \r To ensure that Investigators and Contract Research Organizations appointed to conduct clinical studies are suitably qualified and experienced and to oversee the conduct of clinical studies, ensuring that the required quality standards are met. \r To work with Hygiene Clinical Manager to align on project priorities. \r\r\r\rKey Challenges: \r\r Management of conflicting priorities within designated projects \r Delivery against established timelines \r Management of internal and external interfaces as pertains to GCP compliance \r\r\r\r

Job Requirements
Qualifications:\r\r Bachelor’s degree in relevant field (biological, chemical science or engineering) with over 3-5 years of experience is required.\r Solid experience in the design and execution of clinical cosmetic and/or OTC studies and understanding of ICH/GCP guidelines is required.\r CRA certification such as is strongly desired.\r Strong and well developed motivational and interpersonal skills.\r A clear and logical thinker with attention to detail.\r Pro-active self-direction with a high level of initiative and persistence.\r Understanding priority setting and project management.\r Strong analytical skills with the ability to implement plans.\r Strong communication skills, both written and oral.\r Results oriented, entrepreneurial, self-motivating and bias for action.\r Capable of building strong working relationships to deliver outstanding results.\r Experience in clinical study monitoring is highly desired.\r

Company info

Borough of Montvale, New Jersey
Website :

Company Profile
There are over 300 business and commercial establishments in Montvale, ranging from local merchants to national corporate headquarters. Planned development has resulted in a diversified mix of corporate campuses and smaller concerns. Financial institutions serving Montvale include Summit Bank, Commerce Bank, Hudson United Bank, Chase Home Mortgage Corp., Interchange Bank, First Union and Merrill Lynch & Co., Inc.

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