Clinical Research Associate CRA - 6 month contract with big pharma in Central NJ!

Kelly Clinical Resources is seeking a Clinical Research Associate for a major pharmaceutical company in Central New Jersey. This is a contract position scheduled to last for 6 months.

Job Duties:

Manage all 'in-house' site related activities

Conduct study set-up activities -- including the development of documents used during the study (such as Delegation of Duties Log, Investigational Product Treatment Log, etc.)

Consistently use the study eRoom for sponsor-to-site sharing of documents; post documents as necessary

Maintain communications on a regular basis with the investigator and/or his/her assigned contact

Ensure adequate study and regulatory documentation is properly maintained at both the investigator site and at the customer site

Monitor multiple clinical trial sites and studies

Ensure that Case Report Forms are accurate, complete and verifiable against source documents

Manage Investigational Product accountability on site

Conduct accountability of pharmacokinetic (PK), pharmacogenomic, and other biological samples on site

Identify areas requiring follow-up and improvement at each clinical study site and recommend corrective action

Communicate findings from contact reports and monitoring visits to appropriate customer site staff in a timely manner

Assure adequate reporting of adverse events, protocol deviations, and subject enrollment

Compliance with all federal regulations regarding clinical trials, company SOPs and the clinical protocol

Communicate findings from contact reports and monitoring visits to appropriate customer site staff in a timely manner.

60-70% Travel required depending on the phase of the trial.

No heavy lifting.


Skills Required:

Knowlegde of FDA regulations, ICH/GCP guidelines.

Familiarity with computer systems, or willingness to learn.

Good interpersonal and communication skills (verbal and written).

Self motivation, attention to detail, organizational and time management skills.


Education: CRA II or III level - Bachelors degree 5 + years clinical Research experience including 2 years of field monitoring experience


QUALIFIED APPLICANTS ARE ENCOURAGED TO CLICK "APPLY NOW" FOR IMMEDIATE CONSIDERATION!

Kelly Scientific Resources(KSR) is the scientific business unit of Kelly Services, a Fortune 500 staffing industry leader. We provide scientific staffing services on a temporary, project and full-time basis to a broad spectrum of industries including Pharmaceutical, Biomedical, and Clinical Research.Kelly Services is an Equal Opportunity EmployerContact?Information?:.140 Route 17 North, Ste 314
Paramus?NJ?07652