Sr. Clinical Research Associate

Summary:

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).

Primary Key Responsibilities:

  • Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule.  Adheres to project guidelines and Pharm-Olam 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.


Working Relationship:

  • Reports directly to Clinical Team Leader, Clinical Research Manager or Clinical Operations Manager.
  • Collaborates with Pharm-Olam project team members.
  • Collaborates with Pharm-Olam and local support personnel.
  • Liaises with Investigators, Site Staff, Regulatory Authorities and Ethics Committees.
  • Liaises with Sponsor scientific and medical personnel.
  • Liaises with Vendors and Sub-contractors such as Central Laboratory and Courier organisations.
  • Liaises with Quality Assurance personnel.

Education Requirements 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.

For confidential consideration, please send CV to hr-belgium@pharm-olam.com