Clinical Research Associate Job at Cypress HCM, Maple Grove, MN

UWM5R2hvM0lzOGZoN09PUjcwNGZxV05SY1E9PQ==
  • Cypress HCM
  • Maple Grove, MN

Job Description

A medical device company is looking to hire a Clinical Research Specialist, onsite in Maple Grove, Minnesota. This direct hire employee will report to the Director of Clinical Operations and under their general supervision, will develop, coordinate, administer the logistical aspects of clinical trials according to GCP and SOPs. This person will act as a pivotal point of contact and communication between department staff, clinical sites, as well as vendors.

What You'll Do:

  • Develops, tests, and implements clinical tools to provide relevant information for clinical studies management.
  • Manages clinical study site information and documentation.
  • Requests, tracks, reviews and assures receipt of proper study documentation (IRB approval letters, Signature Pages, Informed Consent materials, signed Clinical Study Agreements, Confidentiality Agreements, etc.).
  • Obtains, reviews, and files site personnel documentation to ensure site compliance.
  • Develops and distributes clinical study documents (Protocol, Case Report Forms, Informed Consent, Agreements, etc.).
  • Routinely corresponds with clinical study sites.
  • Promptly answers sites’ questions and requests with accuracy.
  • Generates and submits memos and study documents (protocol amendments, newsletters, brochures, etc.) to clinical study sites.
  • Generates, reviews, and responds, to queries
  • Coordinates all information regarding reportable Serious Adverse Events and ensures all information is received by the internal team and clinical study sites.
  • Manages payments for sites, data management groups, core laboratories, and Contract Research Organizations, as required.
  • Maintains accurate records and files of study patient data.
  • Coordinates accurate completion of Case Report Forms by timely reviewing Case Report Forms and corresponding with sites to update data and/or creating corrective action plans.
  • Coordinates and performs data input and data verification from Case Report Forms retrieved from sites.
  • Coordinates on-site and off-site Investigator, Study Coordinator and Technologist training meetings and conference calls.
  • Orders, assembles, and maintains supplies of study materials and equipment (handbooks, Case Report Form books, IDE copies, medical equipment, etc.).
  • Other duties, as assigned by supervisor. Takes work direction from the department head and/or clinical research project managers.

Must Have Skills:

  • Bachelor’s degree in engineering, biology, physical sciences, nursing or another related field.
  • One plus years of experience in clinical/medical affairs in the medical device industry
  • Strong organizational skills and detail orientation required.
  • Ability to handle multiple priorities in a fast-paced environment
  • Interpersonal and communication skills necessary to interact with study site personnel and physicians
  • Knowledge of medical terminology and anatomy.
  • Knowledge of FDA guidelines and regulations governing conduct of clinical trials
  • Analytical skills to determine clinical requirements and evaluate software solutions.
  • Ability to make independent judgments.
  • Intermediate skills in Microsoft Office, Word, and Power Point.
  • Advanced skills in Excel, Access, and clinical database software.
  • Ability to travel as needed up to 20% for site openings, trainings and conferences

Salary of $75K-$95K annually

Job Tags

Contract work,

Similar Jobs

Hilton Hotels

Guest Service Agent - Conrad Orlando Job at Hilton Hotels

 ...Hilton Hotels - JobID: HOT0BHW9 [Front Desk Agent / Concierge] As a Guest Service Agent at Hilton, you'll: Greet guests and complete the registration process; Assist guests with check-out; Demonstrate a thorough knowledge of hotel information; Use up-selling techniques... 

LaborMAX

Pressure Washer Job at LaborMAX

LaborMax Staffing is seeking a reliable and experienced pressure washer to join our team! As a pressure washer, you will be responsible for cleaning outdoor surfaces at our clients' homes and businesses. To be successful in this role, you should have at least one year of... 

Kelly Science, Engineering, Technology & Telecom

Design History File Engineer Job at Kelly Science, Engineering, Technology & Telecom

 ...Senior Engineer (Medical Design History/ Product Validation) Location: Lakeland, FL (Hybrid) - Expected to be on site at the Lakeland facility at least three days per week. Type: W2 contract (NO C2C OR THIRD PARTY) Length: until 12/26/2025 (Contract extension... 

Hilton

Guest Service Agent - New York Hilton Midtown Job at Hilton

The New York Hilton Midtownis looking for a Guest Service Agent to join our team. It's all about location in NYC and New York Hilton...  ...greeting and registering guests and checking guests out of the hotel. Specifically, you would be responsible for performing the following... 

Creative Financial Staffing

Tax Accountant Job at Creative Financial Staffing

 ...Are you a detail-oriented Tax Accountant looking to join a reputable, growth-focused organization in the Lutherville area? We're working with a well-established firm that values accuracy, client service, and team collaboration. *This role is 100% on-site. Offering...