Institutional Research Director - Assistant jobs in Middletown, OH

Title: Site Director

Site Director needed for our Clinical Research Site in Dayton, OH

*This position is onsite*

We offer competitive benefits, PTO and 401k

About us:

ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with expertise in early and late-stage neuroscience drug development. With 20 wholly owned clinical sites and 4 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 400 in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes, and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With 5000 completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs.

Job Description:

The Site Director is responsible for the profitable management of the clinical research business, consistent with company policies, principles, strategies, and objectives. Accountable for the overall coordination, organization, and efficient implementation of clinical trials management, operations, and regulatory compliance. Works closely with the Chief Operating Officer, Therapeutic Lead, Chief Medical Officer, Principal Investigators, Recruitment Team and Clinical Research Coordinators to evaluate clinical trials and ensure that all study-related procedures are completed properly from a clinical and a regulatory perspective. In executing these position responsibilities, the Site Director is guided by Good Clinical Practices (GCP), International Committee on Harmonization (ICH) guidelines, HIPAA and company standard operating procedures and policies.

Responsibilities:

Employee Management Responsibilities

• Serve as supervisor and mentor to all direct reports as assigned.
• Perform and/or oversee all HR responsibilities for site staff including but not limited to performance evaluations, corrective action plans, staff recognition, recruitment and onboarding of new employees, optimal conflict resolution, and management of staff schedules.
• Provide access and/or resources for all employees to complete the training needed to perform job responsibilities.

Planning and Management

• Work closely with the site head of Operations (e.g., Clinical Operations Manager, Director or Clinical Operations), develop and implement business plans for achieving the strategic and tactical goals and objectives of the site business.
• Maintain Standard Operating Procedures, working guidelines, quality management plan, and associated training programs for the effective management of all aspects of clinical trial delivery, including but not limited to subject recruitment, appointment scheduling, vendor contracting, IRB approval and interactions, informed consent, subject visits, subject stipend delivery system, source document preparation, timely completion and entry of Case Report Form in EDC and Clinical Trial Management System.
• Manage and motivate site staff to contractual and expected enrollment goals.
• Ensure that all staff are adequately trained and adhere to Standard Operating Procedure and working guidelines.

Business Development

• Participate in Business Development (BD) calls, and or other forums, to review the site’s pipeline for planning purposes and to provide feedback.
• Work with the BD team to complete feasibilities, expedite protocol reviews and “Go-No Go” decisions.
• Evaluate study protocols (e.g., with respect to enrollment/retention potential, site capacity and capabilities, and other determinants of success), with input from the Principal Investigator, Recruitment Manager and Clinical Research team, as necessary for feasibility
• Coordinate site visits and PI Meetings with sponsoring organizations and Clinical Research Staff; provide ongoing coordination of sponsor communications thereafter.
• Interface proactively and collaboratively with centralized services (e.g., Quality Assurance, Central Recruiting, Business Development, etc.). Serve as primary point of contact at the site for ERG leadership.

Subject Recruitment

• Oversee and coordinate plans for recruiting subjects into each study.
• Responsible for proper implementation, expansion, and utilization of subject database.
• Manage and motivate study teams to enrollment goals.
• Participate in Community Outreach events as appropriate.

Quality Assurance and Regulatory Review and Management

• Oversee the preparation and submission of regulatory materials to sponsors and oversight organizations.
• Coordinate approval of materials developed or modified at site by sponsoring or managing organization, as required.
• Coordinate approval of materials developed by site or sponsoring or managing organization by Institutional Review Boards (IRBs) and other outside regulatory organizations, as required.
• Ensure that studies are implemented in compliance with Good Clinical Practice (GCP) guidelines as promulgated by the Food and Drug Administration (FDA) and the International Conference on Harmonization (ICH).
• Design, implement, and / or oversee the ongoing Quality Assurance program for the site. Develop and maintain complete training files for all staff as outlined in the company’s Standard Operating Procedures.

Study Operations

• Contribute to effective management of all aspects of clinical research studies and related office operations.
• Approve all hires and contractors in consultation with Human Resources and the Director of Operations / Clinical Operations Manager as needed.
• Oversee Clinical Research Coordinators on training of all staff for study related procedures. of.
• Coordinate the centralized support services (e.g., Accounting/Finance, Contracting, Business Development, Quality Assurance, etc..).
• Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG’s objectives.

Skills and Qualifications:

• Education and experience
  • B.A. or B.S. required; advanced degree preferred.
  • Minimum of 3 years’ experience in managing clinical trials.
  • Understand regulatory requirements, as well as Good Clinical Practices (GCP), HIPAA and International Conference on Harmonization (ICH) guidelines.
  • Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.
  • Knowledgeable in medical terminology to communicate with physician offices, pharmacists, and laboratory staff.
  • Able to manage a staff of clinical professionals and create a productive, satisfying work environment.
  • Demonstrate the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.
• Requirements
  • Excellent communication skills (interpersonal, written, verbal)
  • Ability to perform overnight business travel.
  • Good organizational and interpersonal skills
  • Attention to detail.
  • Excellent Computer Skills to include Word, Excel, PowerPoint, as well as proprietary applications unique to the clinical research industry (such as Study Manager)