Clinical Research Specialist

Integrated Resources Inc.; Mounds View (MN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Bonus de référence de 500$ par candidat

Job summary

Une entreprise leader dans le domaine des sciences de la vie recherche un Clinical Research Specialist pour superviser des études cliniques. Le candidat idéal aura une expérience en gestion d'essais cliniques et une connaissance des réglementations GCP. Ce rôle clés implique des interactions fréquentes avec les équipes fonctionnelles pour garantir le respect des normes et l'atteinte des objectifs de l'étude.

Qualifications

• Minimum 3 ans d'expérience en recherche clinique.
• Connaissance des bonnes pratiques cliniques (GCP) et des réglementations.
• Compétences écrites et orales solides.

Responsibilities

• Surveillance des études cliniques, y compris le recrutement.
• Audit des fichiers d'étude pour conformité.
• Préparation et communication des rapports d'étude.

Skills

Gestion de projets

Communication

Résolution de problèmes

Attention aux détails

Education

Bachelor's Degree in a scientific field

Tools

MS Office

Job description

Location: Mounds View, MN
Duration: 6 + months (Possibility of extension)

Local candidate needed on site.

Top 3 things CSH is looking for:
1. Clinical trial experience
2. Site Management experience
3. Medical Device experience

DESCRIPTION:

· Coronary Structural Heart Clinical is looking for an enthusiastic, motivated candidate to be a contract Clinical Research Specialist in our dynamic environment.

· The incumbent has responsibility for meeting the milestones of a clinical study in compliance with applicable clinical and regulatory standards and in alignment with the Study Manager as well as business needs.

· Work is completed under general direction.

Travel: N/A
Site: USA-MN-Mounds View
Shift Type: First

POSITION RESPONSIBILITIES

• Oversight of a clinical study including enrolment, long-term follow-up, trial master file maintenance and study activation phases.
• Ensure site compliance in regulatory requirements in regards to tracking site activation documents and ongoing study files by performing study file audits.
• Track device accountability reconciliation.
• Evaluate protocol deviation data during the conduct of the study and for completion of clinical study deviation trending requirements.
• Prepare weekly study reports and record meeting minutes.
• Assist in planning, coordination and preparation of meeting materials for investigator meetings.
• Regularly communicates study status to management.

BASIC QUALIFICATIONS
• Bachelor's Degree in a scientific field of study.
• Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.
• Minimum 3 years' experience directly supporting clinical research or relevant experience in medical/scientific area.
• Master's degree will substitute for 1 year of experience. PhD or MD will substitute for 2 years of experience.
• Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology.
• Computer skills (MS Office products, word processing, spreadsheets, etc.).
• High attention to detail and accuracy.
• Ability to manage multiple tasks.
• Good prioritization and organizational skills.
• Excellent problem solving skills
• Positive outlook.
• Flexible and dependable.
• Works effectively on cross-functional teams.
• Presents professional manner and appearance

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.

Additional Information

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 – 318 -6506| (W) #732-549-2030– Ext – 324 | (F)732-549-5549
Email id – seema @irionline.com| www.irionline.com
LinkedIn: https://in.linkedin.com/in/seemachawhan