Role: Site Director

Company: Profound Research

Location: Detroit Metro, Michigan

The Company

Profound enables community physicians to offer clinical research as a therapeutic option to their patients. We provide all the infrastructure, non-clinical services, and administrative heavy lifting. The physicians practice medicine, we do everything else, and your patients get access to the newest therapies available while you open up a new ancillary for your practice.

Mission, Vision, Values

• Mission: Ensure that every patient has access to the best treatments available.
• Vision: The future of medical innovation rests in the hands of physicians and their everyday care delivery decisions.
• Values:
• Compassion: Honor the patient-physician relationship above all else.
• Efficiency: Accountable for outcomes and strive for process perfection.
• Progress: Contribute to continued innovation in medicine while improving health outcomes.
• Integrity: Hold ourselves to the highest ethical, quality, and scientific standard in every activity.

Profound Ethos

• Physicians are the Vanguard
• All Decisions Improve Patient Care
• Never Compromise Quality

Why this Role Exists

The primary task of a site director (SD) is to manage all aspects of the clinical research program of the

site. The SD must be able to manage multiple trials and perform all tasks to execute, manage, and

coordinate research protocols, recruit subjects, data collection and operations of several concurrent

clinical research studies. The SD will coordinate with the principal investigator(s) (PIs) and sub

investigator(s) to integrate their research tasks with the clinical schedule. Working under the direction

of the PI, develop and maintain effective leadership and working relationships with all site personnel in

accordance with Profound’s policies and procedures. Responsible for guiding site with effective

leadership skills, professional demeanor, and positive approach.

Responsibilities

Lead, Manage and Hold Accountable (LMA)

• Lead and execute clinical research studies and programs for the company.
• Distill research protocols into research plans with time lines and delegation of duties to

appropriate research staff.

• Continually seek to improve site operations to enhance efficiencies to improve the overall

profitability of the site.

• Conduct weekly site meetings to communicate information, provide continuing education,

training and enhance teamwork.

• Manage and establish external clinical/contract research organization (CRO) and clinical study

site relationships. Establish rapport and maintain contact and interact with monitors and

sponsors to ensure customer satisfaction.

• Manage and establish rapport with various persons involved in the study, including but not

limited to the patients, relatives/friends of the patients, doctors, pharmaceutical sponsors and

all levels of the company.

• Act as liaison between site and other departments within company (budgets/contracts, finance,

regulatory).

• Serve as main daily contact to PIs and Sub-Investigator(s).
• Oversee the development, implementation, and updating of SOPs to ensure consistent, safe,

and efficient management of clinical trials and continuous improvements in the fiscal integrity of

clinical research activities.

• Lead the troubleshooting process to reach resolutions for any issues that arise during the course

of a study.

• Maintain responsibility for the cost-effective requisition of needed equipment, supplies, and

outsourced services with acceptable suppliers.

• Ensure site is maintained in an attractive, safe and efficient manner.

Enrollment Accountability

• Provide leadership and manage the study recruitment to ensure enrollment goals are met or
• Generate reports for supervisor on patient enrollment and tracking.
• Tabulate enrollment statistics and implement immediate actions to correct any inadequacies in reaching the site’s enrollment goals.

Feasibility Support

• Facilitate with the submission of feasibility questionnaires by providing prompt responses for

necessary information regarding patient database and other study-related questions.

Quality Control

• Perform quality reviews to ensure the adequate execution of protocols and ensure adequate

site staff training as needed. Ensure that training of investigators and staff are current for all

research studies on an ongoing basis.

• Assist with the development and implementation of corrective and preventive actions to

maintain a high-quality site.

• Maintain meticulous oversight of how the research plan is executed and the performance of

each member of the team.

• Monitor and ensure site compliance with company policies and procedures, quality assurance

guidelines and all federal, state, and local laws.

• Adhere to good clinical practice (GCP), International Conference on Harmonisation of Technical

Requirements for Registration of Pharmaceuticals for Human Use (ICH), National Institutes of

Health (NIH), Health Insurance Portability and Accountability Act (HIPAA), U.S. Food and Drug

Administration (FDA) regulations and standard operating procedures (SOPs) and provides

guidance to site staff on adequate compliance.

• Practical knowledge of document processes and reporting of serious adverse events (SAEs),

1572s, case review forms (CRFs), informed consent forms (ICFs), and other study related

documentation to provide guidance to site staff as well as reviewing to ensure compliance.

• Maintain source documents and subject files in accordance with policies and procedures.
• Ensure accurate, confidential, and complete compilation of data.
• Assist in the maintaining of ongoing regulatory documents.
• Audit operations to ensure compliance with protocol and applicable regulations.
• Coordinate all aspects of the preparation for regulatory agency site visits, including paperwork

required.

• Data analysis and reporting.

Training

• Select, coach, counsel, and develop all site staff to ensure they possess the necessary knowledge
• and skills to achieve quality and revenue objectives.
• Supervise the securing and shipping of clinical specimens as required by the protocol.

Site Business Development

• Assist in defining and developing clinical research strategy and study protocols.

Requirements

• At least two years of clinical research experience preferred. Healthcare experience will be

considered in lieu of research experience.

• Leadership experience required.
• Friendly and outgoing demeanor.
• Must demonstrate a passion for direct patient interaction.
• Demonstrate clinical competence, positive leadership and ability to work collaboratively with a

multi-disciplinary team.

• Regular and punctual attendance.
• Perform other duties as assigned.

Travel Requirements

• Occasional travel may be required in this position (less than 1 month per year)

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer, standing and walking.
• Must be able to lift 25 pounds at times.
• Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.
• Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.
• Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound.
• The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.