Clinical Research Manager I

Join the HJF Team!

HJF is seeking a Clinical Research Manager I to manage in the implementation of clinical research protocols. This is the first of three Clinical Research Manager positions. This position is distinguished by troubleshooting standard operating procedures, dealing with moderately complex problems, and working with higher level managers to deliver solutions.

This position will be in support of Gynecologic Cancer-Center of Excellence (GYN-COE)

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.

• Supervise internal clinical research staff and provide management and oversight of day-to-day clinical research activities at external sites. Implement process and workflow improvements, QC routines and QA reviews. Develop and maintain standard operating procedures (SOPs) for clinical research management, coordinators and assistants. Ensure consistency and accuracy for all clinical and patient-reported data. Strengthen and execute SOPs and training materials. Assess and promote competency and proficiency for internal and external staff and team members and trainees, including but not limited to interns, medical students, residents and fellows as needed.
• Provide internal staff and collaborating sites with assignments, priorities, and SMART goals. Implement initiatives to enhance data quality, recruitment, resolution of queries, and priorities. Investigate issues and provide tailored training, support, and mentorship to team members. Develop and execute corrective action plans, prepare incident reports and perform root cause assessments. Lead by example, meet goals and complete assignments. Maintain compliance with regulations, policies, requirements, and guidance.
• Implement data preparation and clean up, harmonization and standardization for special initiative, projects, and studies. Upgrade and harmonize research records to align different versions of disease classification, staging, grading, disease distribution, and residual disease data. Assemble and distribute clinical dataset lockouts for research investigations.
• Track activities, provide written and verbal updates, generate reports, run teleconference, and give PowerPoint presentations. Create, organize, catalog, disseminate, and maintain the legacy and current data files. Generate weekly, monthly, annual, and final program and site-level reports on staff activities, patient enrollments and characteristics, clinical data, and patient-reported data. Provide content for continuing reviews, briefings, presentations, and updates to summarize OKRs, knowledge products, activities, deliverables, cohorts, clinical datasets and SOPs.
• Interacts regularly with supervisor, clinical team members, clinical investigators, clinical site coordinators, regulatory and safety monitoring staff, data analysts, biostatisticians, program managers, and administrative staff to comply with research, regulatory, compliance, and sponsor requirements. Actively contribute to manuscripts, research investigations, and new funding or collaborative opportunities
• May perform other duties and responsibilities as assigned or directed by the supervisor, including participation and completion of required training and continuing education for this position.

Supervisory Responsibilities

• Assigned Lead: May recommend the following: employee hiring, disciplinary action, and starting salaries; provide input on employee performance evaluations.

Education and Experience

• Bachelor's Degree required in Biology, Epidemiology, Public Health or related field.
• Minimum of 6-8 years experience required.

Or

• Master's Degree required in Biology, Epidemiology, Public Health or related field.
• Minimum of 3-5 years experience required.

Required Knowledge, Skills and Abilities

• Knowledge of federal and local regulations and policies pertinent to research involving human subjects.
• Knowledge of biomedical sciences and clinical research.
• Familiarity with clinical research methods.
• Basic knowledge of microbiology and infectious disease epidemiology.
• Knowledge of PCs including MS Word, Excel, and PowerPoint.
• Ability to write clearly and concisely.
• Excellent communication and interpersonal skills.
• Ability to establish goals and agendas.

Physical Capabilities

• Lifting: Requires lifting materials up to 10 lbs.
• Ability to stand or sit at a computer for prolonged periods

Work Environment

• This position will take place primarily in an office setting.

Compensation

• The annual salary range for this position is $64,200-$95,000. Actual salary will be determined based on experience, education, etc.

Benefits

• HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more.

Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.