JOB TITLE – Clinical Trial Manager
GENERAL SUMMARY OF DUTIES – Responsible for directing and supporting the daily operational and administrative functions of clinical research teams with a focus on project and resource management. Ensures that the work product, policies, and procedures of Atlanta Center for Medical Research, as well as regulatory agencies, are upheld and met/exceeded.
MANAGER- VP, Clinical Operations
SUPERVISES – Research Assistants (RAs), Clinical Research Coordinators
DUTIES INCLUDE, BUT ARE NOT LIMITED TO:
- Performs duties and job responsibilities in a manner that supports the mission, vision, and culture of the company. Communicate and coordinate with all staff levels to assure alignment of strategies, goals, and policies
- Coordinating with cross discipline team members to make sure that all parties are on track with project requirements, deadlines, and schedules
- Champion innovation, leading practices, and continuous improvement within company culture. Benchmark company practices and assess efficiencies and provide recommendations for process and/or system improvements
- Leading the daily clinical operations for study teams, to include:
- Developing, analyzing and implementing timelines for each study/study team
- Managing the study to those commitments and adjusting when needed
- Assigning studies to clinical staff based upon experience and workload
- Maintaining overall protocol timeliness and study enrollment goals
- Submitting project deliverable s and ensuring that they adhere to quality standards
- Drive study start up initiatives and company budgetary requirements
- Collaborating with management team and Investigators to ensure that studies are conducted efficiently and are completed with the highest quality standards and outcomes
- Oversees the following aspect of trials but is not limited to:
- Vendors, Accounting, Regulatory, Client Satisfaction, Recruitment, Quality, Study Start-up and Trial Outcomes
- Monitoring the progress and completion of routine action items and ensuring timely follow-up
- Ensuring proper internal procedures are followed and documentation is obtained from coordinators for approval of retest, unscheduled visits, admits, AE treatments, etc.
Ensuring the proper use of Clinical Conductor (CC) by study team for the tracking of visits procedures as they occur in real time:
On daily basis, reviewing scheduled appointments to ensure they are scheduled to appropriate staff, reassigning as needed
- At the end of day, ensuring all started visits for team have been properly completed and stipends approved if appropriate
- Ensuring proper internal procedures are followed and documentation is obtained from coordinators for approval of inpatient days, retest, unscheduled visits, admits, AE treatments, etc.
- Facilitating change requests to ensure that all parties are informed of the impacts on schedule and budget
- Providing guidance and direction to all clinical staff, including setting performance standards and monitoring performance.
- Identifying the development needs of direct reports and providing coaching or mentoring to improve knowledge or skills
- Assisting external vendors including contract research organizations, sponsors, monitors and external physicians/techs
- Overseeing and facilitating the formal, as well as study-specific, training of study staff, including: New Hire training, EDC, GCP, etc.
- Working to facilitate and support both Inpatient and Outpatient trials
- Working with members of management to prepare, participate in and/or lead study initiations, Investigator meetings, close-out meetings, monitor visits, sponsor audits, etc.
- Acting as liaison between the sponsor, investigator and study coordinator, and other staff, to address issues relating to protocol compliance
- Coordinating/working with study participants to resolve participant issues as they arise
- Working with clinical staff and management to ensure enrollment goals are met
- Writing, helping to compile, and even analyzing reports for teams and/or multiple departments
- Maintaining work area and environment
- Responsible for participating in the selection and hiring of all study staff
- Responsible for participating in the disciplinary process including employee meetings, write-ups, and terminations
- All other duties as assigned
KNOWLEDGE, SKILLS & ABILITIES – This position requires the following minimal requirements:
- Thorough understanding of clinical research terminology, good clinical practices, regulatory and ethical guidelines and regulations as they apply to the conduct studies
- Strong leadership, personnel management and supervisory skills
- Strong customer service and client relationship skills
- Ability to maintain confidentiality as it relates to studies, protocols and client information
- Strong project management skills
- Ability to be flexible and react to change on a daily basis
- Demonstrated ability to identify and analyze complex issues or problems and to recommend and implement appropriate solutions
- Excellent organization and time management skills with strong ability to prioritize and multi-task across competing demands
- Excellent verbal/written communication skills with evidence of effective collaboration across businesses and functions
- High-level computer skills and proficiency with Microsoft Office and Clinical Conductor
- Maintain consistent professional presentation at all times
A successful candidate will be responsible for ensuring Participants, Sponsors and Staff are cared for by following the guidelines provided by Management. The ideal candidate will be a detail-oriented individual that is adaptable to change and has a strong background in Supervision and Organizational Success. The ideal person is a team player able to work in a fast-paced environment and is willing to adhere to the guiding principles and core values of ACMR.
- 5 or more years of experience in Clinical Research environment; 2+ years at ACMR preferred
- 2 or more years of direct project management and/or personnel management experience required
- Experience coordinating clinical research trials preferred
- CCRC Certificated preferred
- CPR training provided
PHYSICAL DEMANDS/WORKING CONDITIONS – Standard operating hours are Monday through Friday, 8:00 a.m. to 4:30 p.m. May be required to complete job-related tasks outside of that time frame, in excess of a standard 40-hour work week. Requires prolonged walking, standing, some bending, stooping and stretching. Requires hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. Requires occasional lifting of boxes up to 50 pounds. Work is performed in a medical office environment and includes exposure to blood-born pathogens and bio-hazardous materials. This role requires the ability to work with a broad range of personalities, situations and psychiatric disorders; therefore, candidates must possess the ability to resolve conflicts immediately and diffuse potentially escalating events before they occur.
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