Senior Clinical Research Manager Medicine Clinical Trials Office

The Senior Clinical Research Manager leads the planning coordination and execution of clinical trials within the Department of Medicine over several divisions. This role ensures regulatory compliance manages research teams and safeguards data integrity to advance medical research and improve patient care.
In partnership with the MCTO Medical Director investigators and MCTO Administration the manager provides administrative oversight for the Department of Medicine Clinical Trials Office (MCTO). The candidate is responsible for implementing and conducting trials involving investigational agents and must possess a strong understanding of medical treatment modalities and clinical research processes.

Senior Clinical Research Manager will report into the Director (for research responsibilities) and MCTO Medical Director (for clinical needs).

Administrative Responsibilities:
Supervises Clinical Research Staff to ensure protocol compliance accurate data collection and sample acquisition.
Manage clinical trials portfolio and assure timely regulatory start-up of protocols.
Monitor accruals and identify growth opportunities for research program.
Maintain clinical research systems required for protocol implementation and data tracking.
Serve as liaison with industry sponsors CROs and MCTO office.
Lead recruitment hiring training evaluation and retention of staff.
Coach and develop team members to foster a high-performance culture.
Oversee clinical research budgets for divisions including forecasting tracking and reconciliation.
Collaborate with business operations to ensure accurate grant and contract management.
Review and approve expenditures ensuring alignment with project goals and compliance standards.

Clinical Research Responsibilities:
Oversee all phases of clinical trials from initiation to closeout in designated clinical area.
Develops and implements ongoing quality improvement activities. Ensures safe efficient and quality research patient care by following the medical centers policies and protocols
The manager is also responsible for cultivating relationships with faculty to support trial development and execution and for creating strategic recruitment plans to ensure timely and effective patient enrollment.
Responsible for establishing a database of patients protocol treatment and follow-up care for patients participating in clinical trials.
Collaborates with primary nursing staff to provide nursing care to patients receiving therapy on a clinical research trial.
Assists the principal investigator in the process of assuring adequate informed consent.
Assures the primary nursing staff understands how to administer investigational agents per specifications of the protocol.
Administration of investigational agents when necessitated.
Assures that blood sampling and specimen preparation is accomplished per specifications of the protocol; and monitors test results as appropriate Documents clinical study and therapy in patients chart and all other databases as required.
Communicates observations/findings to attending physicians and in medical records are required.
Ensures that drug dosing and sample collections times are recorded on study source documentation.
Provides in-service training and serves as a resource to other clinical personnel including physicians nurses pharmacists and other allied health care professionals.
Communicates with referring and affiliated physicians to ensure documentation of clinical findings throughout the clinical trial.
Establishes and maintains database of prospective patients within CTMS.
Oversees scheduling of patient laboratory and radiologic assessments admissions and clinic visits.
Establishes mechanisms to ensure complete and accurate data collection and documentation.
Under supervision may assist in review of protocols informed consents case report forms monitoring plans abstracts presentations manuscripts and Clinical Study Reports (CSRS)
Contributes to SOP development on an as needed basis
Helps resolve routine study monitoring issues

• Bachelors degree in Nursing Biology and Public Health or related scientific/health field Masters preferred.
• 6 years of experience managing clinical trials including 2 years in a management/leadership role
• Must be able to work onsite with occasional travel required

Preferred:

• Strong knowledge of GCP FDA regulations and other applicable clinical research guidelines.
  Working knowledge of regulations and standards applied in clinical area and medical devices is essential
  Advanced project management and multitasking abilities.
  Familiarity with EPIC OnCore REDCap and clinical trial management systems
  Exceptional project management skills with the ability to manage multiple priorities and deadlines.
  Effective written and oral communication skills
  Effective interpersonal skills; able to establish good working relationships and collaborate with networks of employees of all levels; able to foster cooperation in others; creative problem-solver.
  Proficiency in financial management including budgeting and resource allocation.
  Ability to foster a collaborative supportive and high-performance team environment
• Experience in managing and financial management
  Experience in managing cross-functional teams and complex projects