We are currently searching for a skilled professional to join a well-known client’s team as a Remote Clinical Affairs Consultant.  The Clinical Affairs Consultant will be responsible for the management of clinical trials and clinical trial vendors/CRO, achieving clinical trial goals and timelines, and being proactive with internal/external team communications. The consultant is required to be an expert in their assigned disease state(s) and clinical landscape, and therefore providing input for a clinical development program. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

• Responsible for the management of assigned clinical trial(s) and the physician training events by leading cross functional teams that may include tasks specific to study start-up, regulatory, contract and budgeting, safety, medical monitoring, training event planning, etc.
• Serves as the clinical trial/project point of contact and the liaison with the CRO, third party vendors, and organization.
• Responsible for tracking of timelines, vendor management and oversight, regular internal/external team communications, identification and escalation of issues, and coordination with internal departments.
• Supports new studies or product launches, including start-up activities and ongoing field support, as requested.
• Helps to manage and maintain the eTMF and associated files for assigned clinical trial(s) and the physician training events. Knowledge, Skills, and Abilities

EXPERIENCE

• Proficient knowledge of Microsoft Office software, and other general office equipment.
• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing Education/Qualification Requirements

EDUCATION

• Undergraduate degree in Natural Science, Nursing, Clinical Research, Regulatory Affairs or Business or 4 years direct, relevant experience in clinical research or clinical trial-related work and GCP environment to provide a comparable background.

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.