Clinical Research Site Manager

The Site Manager oversees the daily operations and site personnel participating in clinical research. This position performs a diverse role of managerial and administrative responsibilities. This includes but is not limited to analysis, advanced knowledge of study protocols, sound judgment, and strong managerial skills.

The Site Manager reports to the Clinical Site Director/Associate Site Director.

Classification:
Exempt

• Manage all site level clinical research staff to ensure optimal performance on each study.
• Implement company's SOP and site manual procedures, ensuring compliance.
• Collaborate with team to develop and implement an effective enrollment plan to ensure consistent enrollment in line with sponsor's protocol and enrollment period.
• Review and prepare the team of all components of a study prior to initiation date to ensure the teams understands their role and responsibilities for each study.
• Maintain accurate and complete drug/device distribution and accountability records for all investigational products, including proper storage.
li>Ensure compliance according to FDA regulations, GCP guidelines and company's SOP.
• Provide direction and support to team during screenings to ensure qualified subjects are identified and enrolled in the study in a timely manner.
• Ensure Coordinators complete accurate case reports forms per company's SOP, FDA and Sponsor requirements.
• Complete Vendor assessments for any vendors that can affect the integrity of company data.
• Ensure prompt reporting of adverse events to the principal investigator, Sponsor, IRB in compliance with FDA regulations and sponsor requirements.
• Ensure serious adverse events are reported by the coordinator immediately to the Principal Investigator and within 24 hours to the Sponsor, CRO and IRB.
• Ensure complete and accurate information is sent to Sponsor as required per the agreement.
• Inform sponsors and company's QA of upcoming/prospective FDA audits.
• Collaborate with QA to develop an action plan to correct deficiencies identified during the audit. Notify SD/ASD of changes.
• Meet and greet monitors during site visits.
• Complete monthly waterfall in a timely manner.
• Manage sites revenues for maximum site performance.
• Interview potential candidates and identify new team members.
• Train and develop team members.
• Provide constructive feedback to team members in a timely manner.
• Coordinate and lead meetings with the team at least once a month.
• Lead employee performance evaluations and develop goals tailored to each team member.
• Comply with OSHA regulations.
• Other duties as assigned.

• 3 years of clinical research experience preferred.
• 4 years of experience in healthcare field required.
• Minimum 4 years of experience leading and managing teams required.
• Demonstrates superior knowledge of clinical research processes preferred.
• Previous training and experience in clinical research, good clinical practice guidelines, and all applicable FDA regulations, highly preferred.
• Strong understanding of financials and performance metrics.
• Advanced knowledge of computer software in a variety of programs, i.e. Word, Excel, etc.
• Excellent task management and prioritization skills.
• Critical thinking, analytical and mathematical skills.
• Great interpersonal skills.
• Attention to detail.
• Ability to work independently and demonstrate initiative.
• Positive, collaborative, and team oriented.
• Ability to work in a fast‑paced environment and multi‑task in an evolving environment.
• Ability to be ambulatory most of the workday.
• Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination.

We do not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non‑merit factor.

This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job‑related tasks other than those stated in this description.