Sr. Clinical Research Specialist

Job Title: Sr. Clinical Research Specialist
Location: Minneapolis, MN
Duration: 24+Months (Possibility of extension)
Local candidate to Minneapolis, MN needed
Position Description:

· The Sr. Clinical Research Specialist (Sr. CRS) will support the execution of clinical research activities related to the ongoing evaluation of product safety and effectiveness following market release.

· Under supervision, the Sr. CRS may assume project management responsibilities for assigned studies and will be responsible for the timely completion of deliverables consistent with applicable regulatory standards and internal Healthcare requirements.
Position Responsibilities:

· Prepare and revise study materials and/or training

· Conduct training of site and/or Healthcare staff

· Assist in site initiation activities (e.g. study start-up documentation preparation)

· Set-up and maintain accurate progress and study status tracking logs

· Assist in the preparation of reports, regulatory submissions, publications and presentations

· Assist in the preparation of budgets and project plans

· Identify and mitigate quality risk and/or issues associated with assigned studies/activities

· May arrange conference calls, staff meetings, and training events.

· Assist in the preparation and review of data

· Oversee follow-up and resolution of sites issues

· Oversee activities performed by extended team members including work direction (e.g. project coordinators, monitors, safety and data specialists, etc.) to ensure compliance with protocol, appropriate regulations and guidelines

· Able to refer to Standard Operating Procedures (SOPs) and study management processes for guidance on everyday tasks

· Contribute to process improvement initiatives and participate in training to enhance knowledge

Basic Qualifications:

· Bachelor’s degree

· 4+ years’ experience in clinical research (Master’s degree will substitute for 1 year experience)

Desired/Preferred Qualifications:
• Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for conducting clinical studies
• Proficient knowledge of medical terminology
• Computer skill competency (MS Office products, spreadsheets, power points, etc.)
• Ability to work well within teams, build relationships
• Good prioritization and organizational skills, able to manage multiple tasks
• Excellent oral and written communication
• Positive outlook
• Strong communication skills (efficient, effective, transparent)
Physical Job Requirements:

· The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.

· Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

· While performing the duties of this job, the employee is regularly required to be independently mobile.

· The employee is also required to interact with a computer, and communicate with peers and co-workers.

· Ability to travel 10-20%

We do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job.

Thanks & Regards,

Seema Chawhan

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I

DIRECT # - 732-844-8724

Email id – seema @irionline.com| www.irionline.com

LinkedIn: https://in.linkedin.com/in/seemachawhan

Gold Seal JCAHO Certified ™ for Health Care Staffing

“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row