2 Jobs in Somerset, NJ
eTeam is Hiring a Clinical Research Associate Near Somerset, NJ
How do you prefer to interview? Phone followed by onsite or just onsite or just phone. I am fine with phone/video interviews. If someone is local to the northern Illinois area, I can meet them in the corporate office but this is not required.
Will the contractor be required to travel? Maybe, this would not be a deal breaker if someone couldn’t travel. There may be clinical studies that would make the process go smoother if someone could travel to the site rather than conduct activities remotely.
Clinical Research Associate
JOB DESCRIPTION/POSITION SUMMARY: The Clinical Research Associate is primarily responsible for carrying out the responsibilities involved in the execution of clinical trials. This includes site initiation, monitoring and close out of clinical trial sites. Clinical trials may be carried out at various phases in the life cycle of the product.
Responsibilities
- Monitor activities conducted by clinical investigative sites as they relate to sponsor clinical studies to ensure successful execution of the protocol.
- Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), Protocol/Amendment(s), Monitoring Plans, and to quality standards in conducting clinical research.
- Ensure subject safety and verify diligence in protecting the confidentiality and well-being of study subjects
- Conduct site qualification, site initiation, interim monitoring and close out visits for Phase 1-4 studies
- Verify completeness, accuracy, consistency, and compliance/quality of trial data collected at study sites; identify deficiencies and discrepancies and provides remedial training and/or corrective action as required; generate and resolve queries in between monitoring visits
- Complete monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies, and recommended action to secure compliance
- Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem
- The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
- BA or BS with scientific discipline (Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology), RN or BSN degree or equivalent. Minimum of 4 years of clinical research monitoring experience.
- 4 years of clinical research monitoring experience. Experience in on-site or remote monitoring of investigational drug or device trials is required.
- Industry certification - SOCRA or ACRP, or equivalent preferred.
- Read, write and speak fluent English
- This role may be office and/or home-based. Infrequent visits to a Company office may be requested
- Ability to travel preferred but flexible, maximum 25%
- Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable federal regulations.
- Experience in monitoring sites, ability to prioritize and multi-task in a fast-paced environment
- Detailed oriented, with strong time management and organizational skills
- Excellent communication and team skills
- Effective interpersonal skills
- Working knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
- Proficient in Microsoft Office Applications, such as Word, Excel, Access, PowerPoint etc.
- Demonstrated business ethics and integrity.
Job Summary
Full Time
IT Outsourcing & Consulting
$82k-112k (estimate)
06/02/2024
07/15/2024
eteaminc.com
SOUTH PLAINFIELD, NJ
500 - 1,000
1999
Private
BIPIN TAHKUR
$50M - $200M
IT Outsourcing & Consulting
Related Companies
About eTeam
eTeam provides industry-specific, SOW-based services, and global contingent workforce managementsolutions.
The job skills required for Clinical Research Associate include Clinical Research, Clinical Trial, Organizational Skills, Microsoft Office, Time Management, Confidentiality, etc. Having related job skills and expertise will give you an advantage when applying to be a Clinical Research Associate. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Clinical Research Associate. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Clinical Research Associate positions, which can be used as a reference in future career path planning. As a Clinical Research Associate, it can be promoted into senior positions as a Scientist - Clinical Research that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Clinical Research Associate. You can explore the career advancement for a Clinical Research Associate below and select your interested title to get hiring information.
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