MANAGER OF CLINICAL RESEARCH


  • Location: Bozeman, MT
  • Posted: Oct 16, 2019

Job Description


Operational management and oversight of the clinical research department. Responsible for providing overall administrative leadership, business development and operational management for organizing and managing clinic operations. Oversees all aspects of research including seeking out clinical trial opportunities, developing and managing financial performance, directing all activities required to conduct and monitor clinical trials, working with physicians/clinicians, pharmaceutical companies and clinical research organizations (CROs). Ensures adherence to ICH/GCP guidelines, FDA and other additional regulatory requirements or standards of practice. Ensures projects are resourced appropriately and employees are trained to meet project needs. Oversees day to day activities of clinic staff and operations, and functions as a resource for all staff. Creates standards and guidelines for clinical research services.

REQUIREMENTS

EDUCATION

Required:

Bachelor Degree

Preferred:

LICENSURE and CERTIFICATION

Required:

Preferred:

Registered Nurse licensed in Montana

EXPERIENCE

Required:

Minimum of 5 years experience in clinical research. Public relations skills.

Preferred:

KNOWLEDGE OF, SKILLS IN, ABILITY TO, COMPLEXITY AND DIFFICULY:

KNOWLEDGE OF:

All aspects of clinical research site including HIPPA, Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) guidelines, medication and device standards, legal and regulatory aspects (FDA, state and local), personnel management, risk management and research study designs, data review and safety surveillance.
Safety reporting principles, including FDA safety reporting regulations.

SKILLS IN:

Interpersonal and effective verbal and writing communication skills.
Effectively working with departments with diverse needs.
Organizational and time management.
Problem solving.

ABILITY TO:

Work independently, prioritize tasks efficiently and meet time expectations.
Perform reviews of legal records in a timely manner.
Function as a team member.
Interact and collaborate with professionals in various departments, regulatory agencies, pharmaceutical companies, clinical research organizations and investigators.
Comply with written procedures, instructions, and regulatory guidelines
Make timely and well-reasoned decisions and adapt to shifting priorities and demands.
Follow established policies and procedures.

COMPLEXITY AND DIFFICULTY:

Participation in continuing education and other learning experiences.

ESSENTIAL FUNCTIONS

20% Time Spent -
Manages multiple phase 2 through 4 clinical trials in all therapeutic areas.
Accountable for day-to-day operations and execution of clinical trials to ensure trial activities are conducted and adhere to protocol, ICH/GCP, regulatory and SOPs compliance.
Completes all study start up documents needed to initiate the study and submits to sponsor or CRO.
Serves as the primary contact source with sponsors and CROs and works with them on a daily basis from initial contact with site through the close out visit. On site during all visits with sponsors and CROs.

10% Time Spent -
Reviews Clinical Trial Agreements and budgets, negotiates on BH's behalf.
Solicits industry sponsored trials through contacts and professional organizations.
Completes potential study's feasibility assessments.

10% Time Spent -
Prepares and oversees yearly budget
Reviews and approves all appropriate invoices
Coordinates timely payments to study participants as per study inform consent form
Approves office and medical supply purchases
Works to assure study is in compliance with all terms and conditions including IRB approval and conflict of interest.

10% Time Spent -
Serves as primary contact to Institutional Review Board (IRB). Completes and submits start up reports, site status reports, close out reports and any other required reports.
Works closing with coordinators, sponsors and IRB on adverse events and protocol deviations, completing and submitting required documentation.
Primary contact for off-site investigators.
Back up for data entry into studys electronic data base. Answers queries.

10% Time Spent -
Recruits, hires, reviews, supervisors staff and submits payroll
Ensures all key personnel involved in research have completed the required education for their involvement in studies and remains current
Manages staffing productivity
Fosters teamwork, demonstrates effective leadership and communication to providers and staff
Leads internal meetings and ensures minutes and attendance is documented

10% Time Spent -
Works closely with marketing on study advertising. Submits to sponsors and IRBs for approval, maintaining advertising schedule and informing the appropriate individuals of the schedule.
Attends required study related WebExs and teleconferences.
Completes study specific training.
Maintains GCP, BLS and NIH certifications.
On call after hours.

20% Time Spent -
Reviews, develops and ensures compliance with SOPs.
Prepares for and participates in quality assurance audits conducted by study sponsors, federal agencies or specially designated review groups.
Ensures compliance with all appropriate agencies including federal, state and local agencies.
Collaborates with investigators and study site team members.
Meets with system director regularly to discuss on going studies and stratagize for the future.
Establishes and organizes study files including site investigator files.
Retains all records in accordance with sponsor requirements and federal regulations.
Arranges secure storage of study documents that will be maintained according to BH policy or the contract time, whichever is longer.

10% Time Spent -

Other duties as assigned.

Employment Type


  • Full Time

Bozeman Health

915 Highland Blvd
Bozeman, MT 59715

Phone: (406) 414-5421

Web: http://www.bozemanhealth.org

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