Clinical Research Manager

Bristol Bay Native Corportation•Fort Bragg, NC

17d•Onsite

About The Position

Glacier Support Services (GSS), LLC is seeking a qualified Clinical Research Manager at Ft. Bragg, NC to provide the following: Responsibilities: Interacts regularly with clinical investigators, clinical site coordinators, regulatory and safety monitoring staff, laboratory personnel, data coordination center personnel, data analysts, biostatisticians, program managers and administrative staff. Coordinates the execution of clinical research proposals, coordination of the proposal submission and scientific/ethical review processes, management of protocol development activities, oversight, and guidance of protocol execution activities at clinical sites, and ensuring project completion and final product development (e.g., presentation and/or publication, recommendations for changes in clinical practice, provision of pivotal data for product licensure, etc.). Conducts literature reviews and drafts scientific and technical documents under the direction of clinical investigators and other members of the investigative team. Makes recommendations for process improvements and/or enhancements. Contributes to the design and overall goals of the quality control and quality assurance plan for a study, when needed. Contributes to the development and modifications of study budgets and is responsible for budget compliance and development/tracking of protocol performance metrics. May include budgetary responsibility to include plan/forecast and prepare. Adheres to compliance and privacy/ confidentiality requirements and standards, including DOD specific regulations and guidance. Adheres to GCP and compliance regulations for clinical trials. Interview potential participants for clinical trials, collect and analyze data to validate eligibility and subject commitment. Conduct and document informed consent discussions for subjects and inform them of their rights and responsibilities. Educate participants about the clinical trial, their roles in the protocol and any other vital information Act as a research case manager for the subjects. Serve as initial POC for subjects. Collect data appropriately to research protocols. Analyze data resulting from the tests performed on the subjects. Help determine whether data is clinically significant. Address data queries. Act as liaison between participants and physicians. Observe the subjects for improvements, setbacks and changes in conditions as required by protocol. Prepare and maintain manual and computerized data in subject study files according to prescribed standards. Administer investigational drugs as specified in protocols. May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.

Requirements

Bachelor’s degree in related area. Advanced degree preferred.
5-7 years of experience with BA/BS or equivalent years of relevant experience in research environment, preferably in DoD, other government agency, or academia.
Ability to analyze complex problems involving long and short-range planning, including obtaining sources for data and information, recruitment of subjects, and performing study activities.
Excellent interpersonal, organizational, and time management skills.
Ability to take initiative and demonstrate strong commitment to duties.
Organizational skills to establish effective workload priorities to facilitate multiple programmatic functions such as clinical, research, and administrative.
Skill in performing a variety of duties, often changing from one to another with frequent interruptions.
Adaptable to quickly changing priorities and situations.
Performs effectively as motivator of other employees.
Working knowledge of clinical protocol design, content, and categories for inclusion in final document.
Demonstrated skills in employee supervision and HR administration.
Demonstrated ability to develop and implement plans for evaluation and activation of complex research protocols at new sites.
Competent in Microsoft Office (Teams, Outlook, Word, Excel, and PowerPoint).
Excellent computer skills required.
Clearance Requirements: Public Trust

Nice To Haves

Advanced degree preferred.

Responsibilities

Interacts regularly with clinical investigators, clinical site coordinators, regulatory and safety monitoring staff, laboratory personnel, data coordination center personnel, data analysts, biostatisticians, program managers and administrative staff.
Coordinates the execution of clinical research proposals, coordination of the proposal submission and scientific/ethical review processes, management of protocol development activities, oversight, and guidance of protocol execution activities at clinical sites, and ensuring project completion and final product development (e.g., presentation and/or publication, recommendations for changes in clinical practice, provision of pivotal data for product licensure, etc.).
Conducts literature reviews and drafts scientific and technical documents under the direction of clinical investigators and other members of the investigative team.
Makes recommendations for process improvements and/or enhancements. Contributes to the design and overall goals of the quality control and quality assurance plan for a study, when needed.
Contributes to the development and modifications of study budgets and is responsible for budget compliance and development/tracking of protocol performance metrics.
May include budgetary responsibility to include plan/forecast and prepare.
Adheres to compliance and privacy/ confidentiality requirements and standards, including DOD specific regulations and guidance. Adheres to GCP and compliance regulations for clinical trials.
Interview potential participants for clinical trials, collect and analyze data to validate eligibility and subject commitment.
Conduct and document informed consent discussions for subjects and inform them of their rights and responsibilities.
Educate participants about the clinical trial, their roles in the protocol and any other vital information Act as a research case manager for the subjects. Serve as initial POC for subjects.
Collect data appropriately to research protocols. Analyze data resulting from the tests performed on the subjects. Help determine whether data is clinically significant. Address data queries.
Act as liaison between participants and physicians. Observe the subjects for improvements, setbacks and changes in conditions as required by protocol.
Prepare and maintain manual and computerized data in subject study files according to prescribed standards. Administer investigational drugs as specified in protocols.
May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.