Clinical Research Manager

2 weeks ago


St Louis, Missouri, United States Medix™ Full time

Job Overview - Clinical Research Coordinator

Company: Medix™

Compensation: $50,000 - $65,000

Schedule: Monday to Friday, 8 AM to 5 PM

The Clinical Research Coordinator is responsible for overseeing and executing various clinical trials from initiation to completion, ensuring compliance with the study protocol, Good Clinical Practice (GCP), and Standard Operating Procedures (SOPs).

Key Responsibilities:

  • Oversee and execute clinical trials in alignment with the study protocol, GCP, ICH Guidelines, and SOPs.
  • Perform necessary procedures such as venipuncture and other fluid collection methods as permitted by local regulations.
  • Handle the processing, packaging, and shipping of laboratory specimens as required by the protocol.
  • Implement and manage assigned clinical trials, including vendor coordination, subject recruitment, and regulatory document collection.
  • Utilize project management principles to mitigate risks and enhance quality throughout the clinical research process.
  • Develop and execute research and administrative strategies to effectively manage assigned protocols.
  • Communicate professionally with colleagues, leadership, study participants, sponsors, and vendors.
  • Ensure accurate documentation in accordance with ALCOA-C principles during data collection and correction.
  • Maintain confidentiality regarding patient health information and sponsor-related data.
  • Monitor patient safety by ensuring all adverse events are reported in compliance with the protocol.
  • Ensure timely data entry into the sponsor's data portal and resolve all queries promptly.
  • Delegate tasks and provide training to staff as necessary.
  • Prepare and submit regulatory documents to Sponsors and Institutional Review Boards (IRBs) as mandated.
  • Evaluate potential participants for clinical trials through both phone and in-person screenings.
  • Develop and implement recruitment strategies as defined by the Clinical Research Team.
  • Understand critical timelines, endpoints, and patient demographics for each assigned protocol.
  • Comprehend the product development lifecycle and the importance of protocol design.
  • Collaborate with the Clinical Research Team to establish a Quality Control strategy for ongoing work reviews.
  • Perform clinical tasks such as drug preparation and administration within the scope of practice.
  • Other responsibilities as assigned.

Qualifications:

Education and Experience:

  • Bachelor's degree with 2 years of relevant experience in the life sciences OR
  • Associate's degree with 4 years of relevant experience in the life sciences OR
  • High School diploma or technical degree with a minimum of 6 years of relevant experience in the life sciences and 1 year as a Clinical Research Coordinator.

Licenses and Certifications:

  • Phlebotomy certification if required by state law.
  • Certification in intramuscular dose administration if applicable.
  • Certification as a Clinical Research Coordinator through ACRP or SOCRA within six months of employment.

Skills:

  • Strong understanding of medical terminology.
  • Proficient in technology including computers and Microsoft Office Suite.
  • Able to thrive in a fast-paced environment.
  • Excellent verbal, written, and organizational skills.
  • Strong interpersonal and communication abilities.
  • Ability to work collaboratively within a team.
  • Fluent in English, both written and spoken.
  • Capable of managing multiple tasks effectively.
  • Ability to follow established guidelines and protocols.
  • Self-motivated with strong planning and prioritization skills.
  • Adaptable to changing schedules and priorities.
  • Detail-oriented with strong problem-solving skills.
  • Demonstrated leadership capabilities.


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