Pharm-Olam, LLC

Clinical Research Associate I (CRA ACADEMY)

Job Locations US | US-NC-Raleigh-Durham | US
Job ID
2022-3173
Category
Clinical Operations

Why Pharm-Olam

Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.

 

This is Important Work

Ensures that Investigators are conducting clinical trials in accordance with international Regulatory and Ethical guidelines for Good Clinical Practices (GCP) and International Conference on Harmonization (ICH).

 

This is a full-time, direct hire opportunity for clinical research professionals who are interested in becoming a CRA I - participating in our CRA Academy. Ideal candidates should already possess experience within clinical research working as Clinical Research Coordinators / Study Coordinators, Clinical Research Assistants/Specialists with direct patient experience & interaction. Oncology experience would be helpful. Candidates of interest would need to be available to join us for a start date of Monday, 11 July 2022.

 

Your Role

  • Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule.  Adheres to project guidelines and POI SOPs for monitoring requirements.
  • Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
  • Collects and reviews regulatory documents as required.
  • Prepares site visit reports and telephone contact reports.
  • May participate in the start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, and developing study documents.
  • Resolves site issues, including site recruitment challenges and determines status for IP shipment.
  • Works with Project Manager (PM), Clinical Team Leader and/or LCRA (CTL/LCRA), regulatory team members or sponsors to secure authorization of regulatory documents and site contracts.
  • Informs team members of completion of regulatory and contractual documents for individual sites.
  • Attends Investigator Meetings (IM) and study specific training meetings.
  • May translate, coordinate translations or review completed translations of critical documents.
  • May participate in feasibility and/or site identification activities.  Contact local opinion leaders, medical consultants or specified investigators and identify sites with the potential for participation.  Follows the feasibility procedures for documentation of feasibilities performed.
  • Performs internal in-house monitoring tasks.
  • Prepares and attends an Assessment Visit with a more senior CRA, Clinical Team Leader or Clinical Research Manager as required.
  • Assists the Project Team with the day-to-day management of clinical studies as required, including attendance at team meetings.
  • Other responsibilities as required.

Required Education and Qualifications

  • Relevant life science medical / nursing degree or relevant degree or background preferred.
  • Customer service orientation.
  • Sound knowledge of medical terminology and clinical monitoring process.
  • Attention to detail.
  • Ability to perform travel an average of 65%, depending on project needs.
  • Excellent communication in English in both written and verbal skills.
  • Computer literate and proficient in Microsoft Office.
  • Excellent interpersonal and organizational skills.
  • Ability to work independently and to effectively prioritize tasks.
  • Ability to manage multiple projects/tasks, establish and maintain strong working relationships with co-workers, managers, investigators, site personnel and clients.

Apply Now:

 

Please apply online at www.pharm-olam.com/careers

 

Pharm-Olam, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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