Clinical Site Manager I Permanent I Florida, USA

My client is a multitherapeutic network of research sites based in Florida, Alabama and Georgia. They are currently working on the Covid-19 vaccine and are looking to acquire an exceptional Clinical Site Manager to join their team.

The Role

The Site Manager (SM) will serve as the primary contact point between the Sponsor and the Investigational Site. The Site Manager will be assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and applicable regulations and guidelines from study start-up through study closure. The SM will collaborate with the Clinical Trial Assistants (CTA), Clinical Data Management, and Clinical Trial Manager (CTM) to ensure overall site management while performing trial related activities for assigned protocols.

About you

Primary Responsibilities:

• Act as primary contact for assigned sites.
• Execute all activities related to site selection, initiation, maintenance, and close-out
• Ensure site staff is adequately trained (including ongoing site training as needed) and the corresponding training records are complete and accurate at any time point.
• Perform ongoing evaluations of the quality and integrity of site practices.
• Manage progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data entry and query resolution.
• Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
• Promptly communicate relevant status information and issues to CTM and clinical team.

Required Qualifications:

• A Bachelor's degree in a health care or scientific discipline or educational equivalent.
• Minimum of four (4) years of on-site monitoring or relevant experience preferred.
• Alternatively, you should have an equivalent combination of education, training and experience.
• Excellent verbal and written communication skills.

Preferred Qualifications:

• Interpersonal skills - open to others’ ideas and willing to learn new things; respond well to questions and challenges.
• Problem solving – gather and analyze information skillfully
• In-depth knowledge of clinical research operations, regulatory affairs, GCP, and other related clinical research issues.
• Strong ability to work collaboratively in a team environment
• Demonstrate a high level of attention to detail
• Problem solving – gather and analyze information skillfully

Connect

If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.

Medella Life

As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives

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