Operations Research Analysis Manager jobs in North Carolina

Protocol and Safety:

• Ensure the safety and welfare of study participants
• Conduct the study as per protocol, GCP, and SOPs including screening study participants based on protocol inclusion/exclusion, scheduling visits, and obtaining study specific assessments e.g. vitals
• Be knowledgeable of study protocol to ensure all study activities are completed correctly

Recruiting, Screening, and Enrolling Study Participants:

• Assist in local recruiting efforts for clinical trials
• Support to ensure operationally ready to achieve recruitment plans and objectives
• Lead regularly scheduled research meetings with focus on recruitment and retention, study and site updates, and ensuring engagement of CRP and Investigators
• Support site level physician engagement ensuring site recruitment and support

Study Visit Completion:

• Perform delegated research and administrative procedures to assist in conducting clinical studies under the direction of the Investigator
• Perform ECGs, vital signs, meal distribution, study participant monitoring, and other tasks as required by protocol/site
• Perform phlebotomy, point of care testing, sample collection, processing & shipping as required by protocol/site
• Obtain all necessary documentation as required by the protocol
• Timely and accurate completion of source, data, CRFs, queries and CTMS

Safety Reporting & Data Integrity:

• Verify input data and timely documentation regularly and accurately
• Support the review of source docs and other study documents, as required
• Support audit preparation for any site inspections
• Perform regular quality control (QC) checks and other QC tasks as deemed necessary

General:

• Abide by GCP, SOPs, company guidelines, and local healthcare privacy regulations
• Communicate study updates and learnings with applicable staff
• Communicate effectively both internally and externally
• Timely phone, TEAMS and email communication and follow-through
• General site level support
• Travel and support applicable sites within the region
• Ensure confidentiality
• Support feasibility review and submissions, where required
• Conduct/support PSV
• Work independently with little to no supervision

Management:

• Support quarterly recruitment targets and support efforts to achieve site/company KPIs
• Support admin to verify operations metrics are available and accurate
• Support in recruiting and hiring of CRPs
• Supervise, train, mentor and develop CRPs
• Serve as a resource for CRPs
• Train employees and model continuous improvement
• Provide ongoing feedback and coaching to all CRPs
• Conduct reviews/check-ins as outlined by HR and/or Operations Manager
• Approve time off request and timecards
• Anticipate issues and needs for the site based on trends seen at the site level
• Fostering cohesiveness at all levels of the company
• Unify site specific culture and Centricity fundamentals
• Other supervisory responsibilities as assigned

Minimum:

• Canada: College/University degree or equivalent in life sciences related field
• US: HS/GED
• At least 1 year of Centricity Research experience OR (External applicants) at least 3 years working in clinical research and 1 year of management experience

Preferred:

• Post-secondary education in a clinical research program

Prerequisite (Essential):

• Excellent communication skills (verbal and written)
• Excellent computer skills (MS Word, Excel and Outlook)
• Attention to detail
• Ability to manage time efficiently
• Self-directed
• Teamwork & Collaboration
• Proficient level of clinical, interpretive, and analytical skills with organizational skills for project planning
• Flexible & Adaptable
• Strong knowledge of ICH GCP, FDA & HC Division 5 guidelines

Foundation:

• Conflict resolution
• Receptive to feedback
• Empowering & Developing others
• Empathy Skills
• Planning and organizing skills
• Excellent problem-solving skills
• Achievement oriented
• Analytical ability
• Initiative
• Decision making

Leadership:

• Forward thinking
• Innovative
• Creative
• Strategic thinking
• Self confidence
• Strong interpersonal skills