JOB DUTIES INCLUDE BUT NOT LIMITED TO:
- Assist with the initiation, monitoring, and close-out of investigative sites in accordance with FDA/ICH regulations.
- Preparation of monitoring reports and visit letters.
- Track and maintain study specific non-Case Report Form database.
- Administer Clinical research projects; collect investigator documentation, site management, and clinical contact.
- Monitoring of Case Report Forms to identify erroneous, missing, or incomplete data.
- Source documentation verification.
- Auditing of site regulatory files and maintenance of in-house regulatory files.
- Assist with the preparation of scientific reports and study related documents, CRF tracking.
- Perform data analysis and prepare data tabulations.
- Generate queries to resolve problematic data to appropriate personnel, and review responses to assure the database is updated accordingly.
- Report, write narratives, and follow-up on reported serious adverse events.
- Verify study drug accountability, generate and track drug shipments and storage.
- Travel as necessary, based on project needs.
- Perform data collection, retrieval, entry and clean up as necessary.
- Adhere to all policies and procedures related to Safety and Infection Control.
- BS/BA in Life Sciences, Pharmacy, or Nursing,
- Pharmaceutical experience in the pharmaceutical industry or at the hospital segment is preferable.
- Strong verbal and written communication skills
- Ability to work and travel independently with minimal supervision.
- Self-motivated attitude.
- Computer, email and MS Office competency
- Ability to approach problems/decisions analytically
- Time management and prioritization skills
- Attention to detail and the ability to work under tight deadlines
- 401K, Paid Time Off, Life Insurance, Health Insurance and Dental Insurance
Our Company is an equal employment opportunity employer. The Company's policy is not to discriminate against any applicant or employee based on race, color, sex, sexual orientation, gender identity, genetic information, religion, national origin, age, disability, veteran status, or any other basis protected by federal, state, or local laws. The Company also prohibits harassment of applicants or employees based on any of these protected categories. It is also the Company's policy to comply with all applicable state and federal laws respecting consideration of unemployment status in making hiring decisions.
Clinical Research Manager