Responsible for managing resource management, training related to study protocols professional development and all activities associated with the day to day management of GTO Clinical Research Nurses and Coordinators; ensures all operations follow applicable regulations: Code of Federal Regulations Good Clinical Practices (GCP) and International Conference on Harmonization GCP guidelines; state regulations and departmental/institutional standard operating procedures. In close partnership with the Administrative Director, the Research NP Lead and the Regulatory Lead, the Clinical Research Operations Manager is to ensure that all participants involved in clinical research trials in the Gene Therapy Operations are managed uneventfully, safely, and as effectively as possible through their episode of care and participation in the clinical research trial, ensuring participant care is not compromised while participating in a clinical research trial or study.

 

 

Essential Functions:

• Directly responsible for the management and oversight of clinical research nurses and coordinators within the clinical research/inpatient/outpatient spaces and all clinical research projects conducted to ensure compliance with all applicable hospital and research regulations and policies, protection of human subjects, high-quality data collection and effective study enrollment and completion.
• Provides guidance/oversight in close collaboration with the Research NP Lead and Regulatory Lead in all aspects of clinical study coordination including resource and staff management as well as patient safety; troubleshoots clinical study issues including those issues that have operational, compliance and/or regulatory impact.
• Works closely with the Administrative Director and Business Project Manager to ensure staffing and clinical care resources are adequate and compliant with available clinical trial or study budgets.
• Assists investigators and clinical research staff in planning, implementing, educating and evaluating care plans using Evidence-Based Practices in accordance with the requirements of the study protocol. Clearly documents and communicates information both in written and verbal forms.
• Collaborates effectively and communicates needs/expectations/priorities related to clinical trial participation to all involved care providers including GTO clinical staff, attending physician, ancillary service providers (radiology, cardiology, physical therapy, pharmacy, etc.) to facilitate positive patient outcomes both in clinical care and in clinical trial participation.
• Works with the GTO Training/Compliance and Regulatory Teams on the development and implementation of quality and training standards for Clinical Research Nurses and Coordinators to ensure all research is in compliance with regulations.
• Responsible for planning and assigning Clinical Research Coordinators and Nurses to various studies, making organizational and/or resource adjustments as appropriate; Responsible for hiring, training, performance evaluations and firing of Research NPs in collaboration with the Administrative Director and Lead Research NP.
• Commits to continued professional development of self and others.
• Maintains current knowledge of federal, local and institutional hospital and research regulations by serving on hospital committees, reviewing current publications and attending conferences; Advises GTO leadership of regulation/policy changes and projected impact to clinical research operations.

Education Requirement:

BA/BS degree or equivalent experience in medical/science field. Masters

preferred.

Licensure Requirement:

(not specified)

Certifications:

Certification by the Association of Clinical Research Professionals or Society of Clinical Research Administrators or able to obtain within 12 months of hire.

Skills:

• Demonstrated in-depth knowledge of clinical research, IRB, and regulatory regulations, policies and procedures.
• Strong verbal, written, interpersonal communication.
• Goal-oriented; self-directive, initiation, self-motivation, creativity, flexibility.
• Ability to lead others; positive attitude; excellent problem-solving skills, highly effective critical thinking skills.
• Excellent organizational, attention to detail and prioritization skills
• Demonstrated effective conflict management; provides feedback in a constructive way.
• Working knowledge of PCs, word processing, and data management software.
  

Experience:

• Three years of Clinical Research Operations experience.
• Three to five years coordination experience required; past position requiring analytical and organizational skills to compile and analyze data; regulatory/IRB processes; experience managing multiple activities simultaneously.
  

Physical Requirements:

OCCASIONALLY: 1-33% of time (0.5-2.5 hours): Bend/twist, Squat/kneel, Climb stairs/ladder, Flexing/extending of neck

Reaching above shoulder, Hand use: grasping, gripping, turning, Driving (work required) **additional testing may be required, Lifting/Carrying up to 61-100 lbs or greater (with assistance) - Department specific, Pushing/pulling up to or greater than 100 lbs (with assistance) - Department specific, Vision: Depth perception, Color vision, Seeing - far/near, Peripheral vision, Work Environment: Blood and/or bodily fluids, Communicable diseases and/or Pathogens, Chemicals/medications, Patient equipment, Fumes/Gases/Vapors, Biohazard waste, Electricity, Loud noises, Hot and cold temperatures

FREQUENTLY: 34-66% of time (2.6-5 hours): Standing, Walking, Interpreting data

CONTINUOUSLY: 67-100% of time (5.1-12 hours+): Sitting, Repetitive hand/arm use, Computer skills, Audible speech, Hearing acuity, Problem solving, Decision making

Additional Physical Requirements performed but not listed above:

(not specified)