Watertown Categories:
Regional Clinical Research Associate (s) EnVivo Pharmaceuticals
THIS JOB HAS EXPIRED
Regional Clinical Research Associate located in East Coast, Midwest and West Coast. The Regional CRA conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and company Standard Operating Procedures (SOPs) and business processes. The Regional CRA conducts all clinical site activities according to the monitoring plan and in accordance with the study timelines and company objectives.Responsibilities:
This includes but is not limited to:
Manage the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas with the ability to manage, with minimal supervision, sites participating in more complex clinical studies and/or sites requiring more oversight of operational issues
Manage the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives
Ensure quality of data submitted from study sites and assure timely submission of data including appropriate reporting and follow-up for all safety events by site personnel
Ensure safety and protection of study subjects according to the monitoring plan; company SOPs, ICH Guidelines, and federal regulations
Regional CRA Qualifications:
A Bachelor's Degree in a related field or licensed or certified healthcare training (RN, MT, PA, RPh, or RT); or equivalent experience and combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities
2+ years of monitoring experience at a Pharmaceutical Company or CRO
Demonstrate understanding of FDA/EMA Guidelines and GCP
Demonstrate the ability to evaluate medical research data and demonstrate proficient knowledge of medical terminology
Effective organizational and communication skills
Strong attention to detail
Competent use of computer to include data entry, archival and retrieval
Ability and willingness to travel up to 60-80%
Excellent team player with team building skills
Excellent interpersonal skills
Ability to interact well with various team members and provide support to project
Ability to efficiently manage multiple tasks and adjust to rapidly changing environmental priorities
Willingness to work in a dynamic and changing corporate environment
Accommodates a flexible work schedule according to clinical trial(s) priorities, as needed
Demonstrated knowledge of the drug development process with clinical operations administrative experience and skills
Proven ability to independently solve routine problems following standard policies/procedures
| 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 |
