Clinical Research Manager - Emergency Medicine

Albany Medical Center • Albany, NY

1d • $86,651 - $134,309

About The Position

The Clinical Research Manager is expected to provide organizational oversight and management of research staff as well as multiple clinical trials and industry sponsored studies. The position is accountable for assisting in the timely and accurate conduct of research studies being concerned primarily for the protections and care of the patient as a research participant from initiation to completion of study. Activities include participating in the study start up and termination procedures, financial aspects of the study, working with study participants in various study tasks including study recruitment, screening for eligibility, scheduling, physical assessments and biospecimen collection and processing, as well as data collection and study completion duties. Serves as liaison between PI, research site, and sponsor site.

Requirements

• Bachelor's Degree in a related field is required
• Minimum of 4-6 years in a clinical research required and 1-3 years of managerial experience preferred
• Ability to act independently and initiate decisions with attention to detail and follow-up.
• Possess or successfully complete Human Subjects Protection training certification and Shipping of Dangerous Goods certification
• Self-disciplined with excellent organization skills essential
• Must be reliable, flexible and possess excellent communication skills
• Demonstrate a sense of professional responsibility
• Establish a good working rapport with study patients, professional staff, department, institution, and sponsors, and be able to work as a team member
• Ability to work a flexible schedule to meet the needs of the study.
• Familiarity with office equipment (faxes, copiers, phones) and personal computers skills including word processing, spreadsheet and database skills.

Responsibilities

• Oversee and manage clinical research coordinator staff
• Complete and submit protocol specific research site information and confidentiality forms
• Determine feasibility of study considering, appropriateness for patient population, probability of positive outcomes, maintenance of subject safety and confidentiality, fiscal soundness and logistical capabilities
• Knowledgeable on each protocol’s specific inclusion, exclusion, therapy, clinical monitoring oversight, laboratory evaluation, safety monitoring and data management requirements
• Communicate and interact with PI, research team, IRB, WIRB, Institutional Biosafety Committee, Radiation Safety Committee, Impact Analysis Committee, Research Administration, appropriate AMC departments (finance, faculty practice, pharmacy, radiology etc.)
• Communicate and interact with NIH/NCI cooperative groups, pharmaceutical companies, foundations, clinical research organizations (CRO’s), and site research organizations(SRO’s) and government regulatory organizations
• Develop and negotiate budget with sponsor (with assistance of the Research Administration office only as needed)
• Submit the contract agreement draft to the Office of Research Affairs (ORA) for review and approval and work with ORA to address contractual issues with sponsor
• Prepare documents for CMS protocol review required for Medicare coverage
• Prepare and submit all required pre-IRB approval documents for review and approval by the following institutional committees as appropriate: Impact Analysis Committee, Antibiotic sub-committee, Radiation Safety Committee, and Institutional Biosafety Committee.
• Develop, prepare and submit all study documents requiring IRB review, approval or notification. Documents include: submission application, abstract, protocol, informed consent, advertisements, investigator brochures, amendments, progress reports, change in investigators, safety reports, serious adverse event reports, protocol deviation reports
• Prepare and submit documents required by federal regulation and maintain regulatory file and documents to be current and complete. (1572, financial disclosure forms etc.)
• Prepare site for initiation of study by coordinating initiation and training site visits, and preparing documents, clinical units, administrative space and personnel for the study.
• Comply with all regulatory agency requirements and protocol guidelines in implementing clinical trials
• Develop research finance documents including research encounter forms
• Coordinate and conduct recruitment efforts, in-service education and screening programs
• Prepare and coordinate advertisement and media coverage efforts with appropriate AMC departments
• Coordinate dispensing of study therapy through the AMCH pharmacy
• Ensures safety of study specific medical equipment used with research subjects, i.e., EKG machine, phlebotomy supplies; and is prepared for emergencies, equipment failure, user errors and reports such events to management.
• Protect subject confidentiality by assuring compliance with federal regulations and guidelines regarding confidentiality in storage, release of information and disposal of records.
• Plan, prepare for and coordinate monitor and auditor site, pharmacy, and study termination visits
• Assist PI to design, and implement investigator initiated research protocols and supportive database(s).
• Manage and maintain supportive databases integrity
• Assist PI with any special requests for data retrieval, evaluation, and analysis
• Coordinate secure maintenance and storage of all source and study documents.
• Prepare and submit cost center application forms ( pink pages, clinical research checklist, Request to set up Billing form, budget spreadsheet, Unrelated Business Income Tax form) along with negotiated sponsor budget and contract
• Coordinate study closure per protocol and regulatory agency guidelines, ensuring subject safety, preparing all necessary paperwork and summaries, returning unused supplies, complying with audits, and responding to any post study correspondence.
• At all times throughout the study, collaborate with the PI for the protection of human subjects in all the above noted manner and always follow FDA, OHRP and GCP regulations and ICH guidelines and institutional policies and procedures.
• At all times throughout the study, coordinate the subject’s health care in the interest of the patient first in communication, education, clinical decision making, assessing needs, and utilizing resources.

Benefits

• Excellent health care coverage with no copay at Albany Medical Center providers
• A wide array of services and programs to support emotional, physical, and mental wellbeing

What This Job Offers

• Job Type: Full-time
• Career Level: Manager