Clinical Research Associate (Contract/Fulltime)

: Clinical Research Associate

Summary:

An important role of the CRA is to ensure 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).

· Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines and ClinChoice 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.

· 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 Investigational Product (IP) shipment.

· Works with Project Manager (PM), Clinical Team Leader (CTL) and/or Lead CRA (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 and may present at Investigator Meetings (IM) and study specific training meetings.

· May translate, coordinate translations or review completed translations of critical documents.

· Participate in feasibility and 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 assessment visits with less experienced CRAs, as required.

· Assists the Project Team with the day-to-day management of clinical studies as required, including attendance at team meetings.

Working Relationship:

· Collaborates with ClinChoice project team members.

· Collaborates with ClinChoice and local support personnel.

· Liaises with Investigators, Site Staff, Regulatory Authorities and Ethics Committees.

· Liaises with Sponsor scientific and medical personnel, as required.

· Liaises with Vendors and Sub-contractors such as Central Laboratory and Courier organizations.

· Liaises with Quality Assurance personnel.

Requirements

· Minimum of 2 to 3 years of CRA experience or 3 years’ experience as a study coordinator.

· BA/BS degree life science medical / nursing degree or relevant degree or background preferred.

· Customer service orientation.

· Sound knowledge of medical terminology.

· Attention to detail.

· Ability to travel for 3 to 5 days on site per month, this may increase or decrease depending on the 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 Sponsor.

· Ability to manage more than 1 study simultaneously.

ClinChoice is an Equal Opportunity Employer / Committed to Diversity