Job Description

The Clinical Research Project Manager position is an excellent opportunity for an individual who is interested in assisting a fast-emerging biopharmaceutical company conduct unique first-in-human, clinical research trials with multiple therapeutics. You will work under general supervision to manager a number of clinical research studies and manages data collection and submissions for multiple clinical trials. This position entails a high volume of document control and data abstraction; no patient contact.

Principal Duties And Responsibilities

The following duties will be performed under general supervision by the VP of Research and Manufacturing:

· Manage several ongoing and future clinical research project

· Write clinical research protocols

· Monitor and evaluate protocol compliance

· Manage data collection via chart abstraction and submit data

· Write informed consent documents

· Monitor and report adverse events as required by institutional/federal regulations

· Prepare submission of protocol revisions and safety reports to the IRB

· Prepare annual progress reports for IND and IRB renewal of ongoing studies

· Organize monitoring visits as requested by sponsors and make data corrections as required by monitor

· Resolve data discrepancies

· Assess impact of new risk information on consent documents and revise appropriately

· Exercise sound judgment in making critical decisions

Skills/Abilities/Competencies Required

· Careful attention to detail

· Good organizational skills

· Ability to follow directions

· Good communication skills

· Computer literacy

· Working knowledge of clinical research protocols

· Ability to demonstrate respect and professionalism for subjects’ rights and individual needs

Education

· Bachelor’s degree required.

· Minimum 2 years of relevant experience

Primary Location

Remote

Job

Research-Management

Organization

ZEO ScientifiX

Seniority Level

Mid-level Associate

Industry

• Biotechnology

Employment Type

Full-time

Job Tags

Similar Jobs