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Clinical Research Associate EnVivo Pharmaceuticals
THIS JOB HAS EXPIRED
Clinical trial operational site support including all processes related to study start-up and site management through close-out, assuring GCP and ICH practices and compliance. A qualified clinical research associate will conduct site initiation visits, interim visits, co-monitoring visits and close-out visits; either writing reports or reviewing monitoring reports provided by Contract Research Organization (CRO).Principal duties and responsibilities include the following:
Ensures compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/study coordinators, and follow-up of corrective actions
Conducts on-site interim monitoring visits, co-monitoring visits with CRO, and site closure visits of all phases of clinical trials
Reviews study data for completeness, accuracy and consistency with study protocol and investigator?s records
Interfaces with clinical sites/investigators on-site and through administrative site management to ensure compliance with protocols and regulatory compliance
Prepares and tracks required documentation from clinical sites
Serves as primary contact for clinical site personnel for addressing routine questions regarding the execution of the protocol and subject eligibility
May serve as in-house site administrator for regional CRAs with supervision
May assist with the development of case report forms and data queries
Participates in in-house and/or external training and educational opportunities to build expertise and monitoring skills
May conduct Site Qualification and Site Initiation visits
REQUIREMENTS:
Bachelor?s degree in a scientific discipline, RN or BSN degree or equivalent; 2 years previous clinical experience
Strong interpersonal skills, exceptional organizational and time-management skills, and oral and written communication skills are essential
Knowledge of local regulatory requirements
Demonstrates the ability to interface with clinical sites/investigators to ensure compliance with protocols and regulatory requirements
Capable of working on clinical monitoring issues of moderate scope
Exercises judgment on routine clinical procedures and practices to determine appropriate action
Generally receives instructions on routine work and detailed instruction on new assignments
Must be willing to travel (50% of time)
| Location: | 480 Arsenal Street Building 1 Watertown, MA 02472 United States |
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THIS JOB HAS EXPIRED
EnVivo Pharmaceuticals
Investors: BCM Technologies, Fidelity BiosciencesAll Jobs: at EnVivo Pharmaceuticals
| Web Site: | www.envivopharma.com |
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| Headquarters: | 480 Arsenal Street Building 1 Watertown, MA 02472 United States |
| Industry: | Biotechnology |
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