Clinical Research Manager (Sr HSRC)
Company: University of Rochester
Location: Rochester
Posted on: May 28, 2023
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Job Description:
GENERAL PURPOSE:
Under general direction from the Research Program Administrator,
with direct supervision from Division Research Administrator, and
with considerable latitude for the exercise of independent
judgment, manages the technical/administrative, financial, quality,
and personnel management functions of the Clinical Research Group
in the Division of Pulmonary and Critical Care. Plans, directs,
monitors and coordinates all phases of human subject research
(which may include multi-site and community-based research, as well
as multiple therapeutic areas). Manages, designs, implements and
evaluates study changes. May supervise others.
JOB DUTIES AND RESPONSIBILITIES:
Oversight of assigned study personnel including orientation,
training, documentation of core competencies, certification
mandates, safety/responsible conduct of research education and
performance evaluations, including the following tasks:
Manages the day to day communication and shared activities for
human subject research studies involving units within and external
to the University, issue resolution, and supervision of assigned
staff
Completes annual performance evaluation process, in tandem with
Research Administrator; ensures fair and accurate evaluation
following standards of performance. Provides counseling and
constructive feedback for employee development.
Performs QA and supervision of team OnCore entries, research tabs
and reports.
Participates in staff recruitment and retention initiatives
Manages coordinator effort reporting activities.
Participates in department wide team building and training
activities.
Manages the studies and portfolio including the following
tasks:
Provides professional direction for the projects. Creates, plans,
develops, implements and manages study design, budgets, protocols,
consent forms, processes and policies that may include multiple
therapeutic areas.
Organizes and plans project start-up including working with the
sponsor and internal resources (CRC, IDS Pharmacy) on budget and
agreement, applying for IRB other ancillary approvals.
Prepares and negotiates clinical trial budget for sponsor approval
and compliance review
Reviews potential projects for feasibility, in terms of staffing
needs, recruitment, financial break even analysis and scientific
overlap with existing studies
Manages all aspects of OnCore for study start up; creates study in
OnCore, works with OCR on study calendar build, and enters budget
for compliance review
Designs source documents and databases. Prepares documents for
study sponsor and regulatory agencies including WIRB, RSRB, NIH,
and FDA.
Prepares reports for FDA and IRB.
Evaluates protocols and develops protocols from awarded grants.
Writes informed consent forms.
Provides coverage and back-up for team CRCs (Clinical Research
Coordinators) as needed.
Provides leadership in problem solving logistical challenges to
assure study objectives are achieved according to protocol and
projected time-lines.
Acts as point person for clinical triage as PI is often not readily
available on a daily basis.
Uses clinical judgment in reviewing clinical labs and adverse
events as well as prepares and reviews Serious Adverse Event
reports.
Reviews and responds to data queries.
Project Management:
Provides professional direction and oversight for multicenter
projects which include providing direction for institutions outside
of URMC, participating as subawards.
Maintains and tracks regulatory compliance for multicenter studies
and assists in IRB approval and documentation at URMC and other
participating institutions.
Tracks and documents research milestones and activities conducted
both at URMC and outside of URMC for the purpose of meeting NIH
goals and managing external institution invoicing and payments.
Communicates frequently with external institutions to assure
compliance with multicenter research activities and provides
direction for those institutions in regards to research compliance,
training recruitment, invoicing and reporting.
Assists in the training, onboarding and participation of URMC
staff/faculty and staff/faculty at external institutions.
Assists in the development and creation of project specific
documents used at multiple institutions such as protocols, consent
forms, source materials, recruitment materials and database
forms.
Professional Development:
Obtains and/or maintains clinical research certification.
Demonstrates accountability for continuous learning in accordance
with Good Clinical Practice standards and guidelines.
Maintains requisite skills and mandatory training in safety,
equality, responsible conduct of research, continuing education,
and research competencies.
Maintains CITI and Conflict of Interest (COI) certification and
renewal as required.
Maintains proficiency in UR-specific research software needed to
manage clinical research protocols.
Assumes personal responsibility for keeping up with new
developments in the field, related literature, and relevant
clinical standards. Assists in helping others in same.
Participates in protocol-related training as required.
Complies with Good Clinical Practice and the Code of Federal
Regulations:
Performs Division audits for compliance.
Ensures proper study documentation is on file in the investigators'
files for the Sponsor, IRB, FDA or other federal agencies.
Oversees compliance with and effectiveness of Clinical Research
procedures; recommends revisions as needed.
Demonstrates initiative in improving operational and financial
performance with effective decision-making, planning and
implementation skills.
Keeps current with all federal, state, sponsor, and institutional
policies and laws, standard operating procedures (SOPs), and
guidelines.
Keeps current with industry standards, best practices, and trends
relevant to research studies.
Ensures proper study documentation is on file in the investigators'
files for the Sponsor, IRB, FDA or other federal agencies.
Oversees compliance with and effectiveness of Clinical Research
procedures; recommends revisions as needed.
Demonstrates initiative in improving operational and financial
performance with effective decision-making, planning and
implementation skills.
Keeps current with all federal, state, sponsor, and institutional
policies and laws, standard operating procedures (SOPs), and
guidelines.
Keeps current with industry standards, best practices, and trends
relevant to research studies.
QUALIFICATIONS:
Bachelor's Degree required.
Master's Degree in a health-related field preferred
5 years of experience in human subject research coordination
required
or equivalent combination of education and experience required
Preferred:
Experience as Human Subject Research Coordinator II
Demonstrated leadership skills and competency.
Ability to effectively manage complex research
protocols/procedures.
Proficiency in medical terminology, the clinical research process
and applicable regulatory guidelines and standards.
Proficiency in managing multiple and competing
priorities/demands.
Thorough knowledge of and established track record in assuring GCP,
Responsible Conduct of Research standards, applicable safety
standards, OSHA guidelines, throughout study implementation.
Exceptional interpersonal, organizational, and time management
skills; highly collaborative, promotes teamwork.
Ability to build collaboration among research team members,
laboratory staff, patients and families, clinical services
(requires tact, sensitivity, clarity, flexibility, empathy for
patients).
Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email,
internet.
Possesses a high degree of self-motivation; recognized ability to
function independently.
SoCRA or ACRP and CLASP certification preferred.
The University of Rochester is committed to fostering, cultivating,
and preserving a culture of equity, diversity, and inclusion to
advance the University's mission to Learn, Discover, Heal, Create -
and Make the World Ever Better. In support of our values and those
of our society, the University is committed to not discriminating
on the basis of age, color, disability, ethnicity, gender identity
or expression, genetic information, marital status,
military/veteran status, national origin, race, religion/creed,
sex, sexual orientation, citizenship status, or any other status
protected by law. This commitment extends to the administration of
our policies, admissions, employment, access, and recruitment of
candidates from underrepresented populations, veterans, and persons
with disabilities consistent with these values and government
contractor Affirmative Action obligations.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled
Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
Opening: Full Time 40 hours Grade 055
Keywords: University of Rochester, Rochester , Clinical Research Manager (Sr HSRC), Executive , Rochester, New York
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