Job Description

JOB DESCRIPTION

Tandem Clinical Research is a clinical research company dedicated to testing investigational medications and devices that cover a broad range of diseases and disorders. We are actively seeking a Regional Director of Operations to join our Albany Team.

The Site Director oversees all aspects of the clinic and staff. The Site Director is responsible for supporting the department managers as they manage the day to day of the operation while ensuring that all required procedures and visits occur according to protocol and within local and federal guidelines.

RESPONSIBILITIES

· Manage operations of the Clinics

· Train and develop department leaders

· Defining, implementing and revising operational policies and guidelines for the organization

· Monitor productivity of the clinic

· Participate in Financial meetings

· Manage forecast and budget for the clinics

· Ensure financial success of the clinic

· Engage department leaders in all aspects of the operation

· Work with HR department to implement hiring procedures

· Oversee department training programs

· Selecting and retaining top talent

· Lead all departments to ensure successful trials

· Conduct informed consent process and conduct study related visits.

· Monitor subjects per protocol requirements.

· Assess, monitor, and report adverse events per protocol.

· Maintain required records of study activity including source documentation, case report forms, drug dispensation records, and data management system entry.

· Dispense test articles, calculate dosages if needed, and provide instructions

· Complete case report forms and resolve queries.

· Report protocol deviations to PI, sponsor, and IRB as required.

· Obtain, process and ship study related specimens.

· Provide assistance to fellow study coordinators.

· Manage quality assurance activities for assigned protocols per site SOP’s.

· Ensure adherence to study protocols and study quality, maintains subject confidentiality.

· Prepare and present corrective action

· Monitor all aspects of the clinical trials assigned

· Lead investigator meetings, site initiation meetings, etc. as needed

· Monitor all departments and ensure compliance with protocol and all applicable regulations

· Ensure adherence to study protocols and study quality, maintains subject confidentiality

· All other related duties as assigned

· Participate in occasional outreach community events

KNOWLEDGE, SKILLS, AND ABILITIES

· Must possess excellent leadership, organizational, computer, and communication skills.

· Ability to manage managers.

· Ability to multi-task, prioritize appropriately, and work well both individually and as part of a team.

· Ability to use time productively and contribute to high levels of company operational efficiency and effectiveness.

· Ability to maintain confidentiality of information.

· Ability to communicate in an active multi-office environment.

· Ability to efficiently operate all job-related office equipment (telephone, computer, calculator, fax, copier, study-specific equipment).

· Conflict resolution skills.

Required Experience:

· Bachelor’s Degree Required

· MS, LPN, RN, or other medical license or certification a plus

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