Clinical Research Supervisor (Research Department)Apply Now
Essential Job Functions:
- Supervise the Clinical Research Coordinators at SMGO-BMC in the coordination and facilitation of site qualification visits, site initiation visits, site closure visits and interim monitoring visits and assure all required attendees are notified in advance and available.
- Evaluate potential clinical research studies together with clinicians.
- Responsible for budgeting for clinical trials and negotiating budget with Sponsor. Create AR/AP spreadsheets for each Protocol and work directly with finance to facilitate physician compensation and patient stipends, if any.
- Together with investigator, assess Protocol requirements for patients and identify standard of care vs. non standard of care.
- Maintain specific knowledge of protocol(s), including objectives, rationale, and description of investigational product inclusion/exclusion criteria, study visits/procedures and medications.
- Perform Clinical Trial-related evaluations as required by Protocol and commensurate with skills and experience (medical histories, vital signs, blood draws, EKG's, etc.)
- Work with the Principal Investigators and staff Clinical Research Coordinators to ensure proper subject recruitment, screening, enrollment, and scheduling. Together with staff Clinical Research Coordinators, assist Principal Investigators with Informed Consent process.
- Work with the Principal Investigators to recruit patients, monitor their study progress, and work closely with patients to assure visit schedule compliance.
- Responsible for administrative and regulatory aspects of pre-study and site initiation planning.
- Assure accuracy and integrity of Clinical Trial study data in compliance with Protocols, FDA regulations, and Sponsor requirements.
- Under the supervision of the Principal Investigator, transcribe clinical data from the medical chart to the Sponsor data collection tool.
- Manage and supervise the Clinical Research Coordinators as it relates to tracking data forms, reports, and documents necessary for completion of Clinical Trials.
- Under the supervision of the Principal Investigator, collect and manage laboratory specimen collection and shipping according to Protocol and other applicable regulations.
- Monitor subject safety through routine subject follow-up and records Adverse Events (AEs) as governed by GCPs.
- Develop study specific source document templates, forms, and tools to expedite the accurate collection of data.
- Develop and maintain Standard Operating Procedures for Clinical Research at the organization.
- Provide recommendations for continuous process improvement and maintains working knowledge of the Research Department Standard Operating Procedures.
- Together with the Clinical Research Coordinators, perform periodic QA; review ICFs, source documentation, IP logs of research team members to ensure accuracy and compliance.
- Maintain Active New, Visit and Deviation logs.
- Manage and supervise team of Clinical Research Coordinators at SMGO-BMC.
- Oversee the planning of Department and Research Review Committee meetings; work collaboratively with the physician leadership on meeting agenda.
- Work collaboratively with Physician Acquisition/Integration and Business Development to coordinate and oversee onboarding of physicians and physician practices to educate on the function and role of the Clinical Research Department.
- Perform other related duties as assigned.
General Job functions:
- Other job duties as required, working under the supervision of the Principal Investigators, physician leadership and the Vice President -- Associate General Counsel.
Education, Certification, Computer and Training Requirements:
- Associate's Degree required; Bachelor's Degree preferred
- RN, LPN, MA, or equivalent with proper licensure. ACRP Certified Clinical Research Coordinator. Maintain a valid CPR certification.
- 10+ years of experience working in the clinical research setting at a health care institution
- Knowledge of FDA regulations for Clinical Trials.
- Ability to follow protocol precisely, without deviation.
- Ability to effectively communicate in English, both orally and in writing.
- Must possess strong attention to detail and organizational skills.
- Ability to multi-task and prioritize workload.
- Ability to maintain confidentiality.
- Experience with Standard Office Equipment (Phone, Fax, Copy Machine, Scanner, Email/Voice Mail) required.
- Experience with Standard Office Technology in a Windows based environment.
Physical Job Requirements:
- Physical mobility, which includes movement from place to place on the job, taking distance and speed into account.
- Dexterity of hands and fingers
- Endurance (e.g. continuous typing, prolonged standing/bending, walking)
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