Clinical Research Site Director - San Diego, United States - Evolution Research Group

Description

Job Details

Job Location
LOC020 PRN Pacific Research Network San Diego - San Diego, CA

Clinical Research Site Manager/Director


Title:
Site Director


Location:
San Diego, CA

Exciting opportunity at local clinical research site. Great benefits, competitive salary and matching 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 access to over 32 million patients/subjects and completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.

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 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.

Why work here?

We are committed to fostering, cultivating & preserving a culture of Diversity, Equity & Inclusion.

We believe that this isn't just the right thing to do, it is crucial to the success of the company.

Our employees are our most valuable asset.

Benefits-matching 401k, PTO, medical, vision, dental and competitive compensation


Responsibilities:
Employee Management Responsibilities
Serve as supervisor and mentor to all direct reports as detailed by the organizational chart.

Perform and/or oversee all HR responsibilities for reporting staff including but not limited to performance evaluations, corrective action plans, staff recognition, recruitment and onboarding of new employees, 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 Director of Operations, develop and implement business plans for achieving the strategic and tactical goals and objectives of the business.

Maintain Standard Operating Procedures, working guidelines and associated training programs for the effective management of subject recruitment, appointment scheduling, informed consent, subject visits, source document preparation, timely Case Report Form and EDC completion and regulatory affairs.

Ensure that all staff are adequately trained and adhere to Standard Operating Procedure and working guidelines.

Business Development
Participate in weekly Business Development (BD) calls 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 and contributes to decision as to which studies to pursue.

Coordinate site visits and PI Meetings with the BD team and sponsoring organizations prior to study implementation and works with Clinical Research Staff to provide ongoing coordination of sponsor communications thereafter.

Subject Recruitment
Oversee plans for recruiting subjects into each study.
Direct activities of the Recruitment Manager.
Approve media and resources to be used for subject recruitment.

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).

Work closely with the VP of Quality to design and implement a Quality Assurance program for all research activities.

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 as needed.
Support the Senior Research Coordinator on training and management of Clinical Research Coordinators and all other research staff.
Coordinate the support services (e.g., accounting/finance, contracting, facilities, etc.).
Ensure that Study Manager is being used by staff to effectively manage and business activity.
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)

#MEDHP
#J-18808-Ljbffr