We are currently searching for a skilled professional to join a well-known client’s team as a remote Regional Clinical Regional Associate. The Regional Clinical Research Associate provides site qualification, initiation, remote and interim monitoring, and study closeout visits.  Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

Responsibilities:

Conduct site qualification, initiation, remote and interim monitoring and study closeout visits for pediatric and adult nutrition and Phase 1-4 studies in accordance with the protocols, federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Company Standard Operating Procedures (SOPs) and business processes.  Set up study site management in Clinical Trial Management System (CTMS).  Collect and manage essential documents for assigned study sites.  Conduct all clinical site activities according to the monitoring plan and in accordance with the study timelines and company objectives.

This includes but is not limited to:

Manage the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas.

Manage the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives.

Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.

Ensure safety and protection of study subjects according to the monitoring plan, SOPs, ICH Guidelines, and federal regulations.

Perform CTMS site management set up for assigned sites.

Collect and upload into SharePoint critical documents & maintain Permanent Study Files for assigned sites throughout the life of the trial. Prepare, review, submit to second reviewer and sign-off on Essential Documents Packages (EDP).

Perform on-site product inventory count and for unblinded studies compare to site’s product inventory records to identify any discrepancies.

Prepare and make IRB submissions for sites, as needed.

Train study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.

Appropriately escalate serious or outstanding issues to the Clinical Operations Project Lead or the appropriate project team member(s).

Facilitate Quality Assurance Audit processes as indicated.

Ensure regulatory inspection readiness at assigned clinical sites.

RESPONSIBILITIES:                                                                                                     

Report monitoring activities and study site conduct accurately and completely.  Prepare and submit written reports, both monitoring and administrative, in a timely, concise, and objective manner.

Interact and build professional and collaborative relationships with all study personnel (investigator, study coordinator), peers and office-based personnel.  Use multiple technologies to maintain open and frequent communication with personnel.

Identify, evaluate, and recommend new/potential investigators/sites on an on-going basis.  Potential sites may be identified through networking or internal requests to assist in the placement of planned clinical studies with qualified investigators.

Participate in departmental and clinical study team meetings.

Employ good fiscal management to conserve costs of departmental operation and control travel expenses, with guidance from the Clinical Operations Project Lead and managers.

Identify and partner with other personnel to develop innovative processes and technologies to increase the quality, productivity, and efficiency of Clinical Operations and conserve overall departmental operating costs.

Maintain knowledge and expertise across multi-therapeutic areas through clinical and scientific literature review, ongoing awareness of industry practices and participation in professional activities.

Create a positive work environment by encouraging mutual respect, innovation, and accountability at all levels.

Travel up to 70%

Qualifications:

• Bachelor’s Degree, preferably in a clinical science/nutrition/nursing field, or Associate's Degree/RN, with relevant clinical experience is required
• Minimum of 3-5 years of clinically-related experience, of which 3 years must be in clinical research monitoring
• Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials
• Solid knowledge of regulations governing clinical research, ICH/GCP Guidelines and/or federal regulations, and applicable local regulations
• Experience in on-site monitoring of investigational products (e.g. drug, device, medical food, and/or infant formula) is required.
• Demonstrated strong site management and monitoring skills
• Exhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
• Good written and verbal communication skills
• Acute observational skills, analytical and conceptual capabilities
• Exhibit high degree of flexibility when facing changes in the work environment
• Competence in the use of personal computers, including experience with word processing, spread sheets, email and web-browser applications.
• Previous experience with electronic data capture systems desirable
• Strong ability to work independently with minimal supervision.