Clinical research director job description

EAMC MISSION

At East Alabama Medical Center, our mission is high quality, compassionate health care, and that statement guides everything we do. We set high standards for customer service, quality, and keeping costs under control.

Essential Job Functions:

Adheres to GCP, FDA, and Organization guidelines when implementing research trials to ensure highest quality research within Organization.

Ensures patient eligibility in research study, all protocol procedures and data collected are completed per protocol.

Ensures all documentation is completed to ensure high quality of research and sponsor satisfaction.

Coordinates and prioritize multiple clinical trials to ensure production in the Institute of Research and Education.

Works in a collaborative manner with research staff in order to meet research objectives of the team.

Has detailed knowledge of all components of the research study protocol by creation of study packets, in servicing hospital staff and departments, and completion of all regulatory documents complete

Ensures all regulatory documents are complete and submitted to Institutional Review Board and study sponsor prior to any research activities being initiated

Identifies prospective research patients by rounding and screening appropriate areas demonstrated by screening logs and enrollment handed in weekly to sponsor and management coordinator

Recognizes and interprets diagnostic, physical and psychological findings and incorporates these findings to determine patient eligibility in study as demonstrated by appropriate patients enrolled in studies and no protocol deviations identified by sponsors

Completes all procedures identified by protocol demonstrated by no protocol violations from the sponsor and quality review tool by Institute of Research and Education staff

All data points and case reports forms are completed with in 4 weeks of patient enrollment or study visit.

All Institutional Review Board documentation and notifications of AE, SAE amendments and continual reviews are reported to Institutional Review Board per Institute of Research and Education/Institutional Review Board SOP's.

Manage multiple clinical trials.

Maintains study enrollment as measured by 75% enrollment rate

Assist, volunteers and communicates with peers for 24 hour coverage of all research protocols

Serves on one unit or hospital committee as requested

Attends 90% of weekly team meetings and 90% of all staff meetings

Completes weekly tracking sheets

Minimum Education

? Bachelor's Degree

Minimum Experience ? Minimum 5 years clinical research experience

Required Registration/License/Certification Obtain and pass CRC req's after 2 years (and with required number of hours worked in the research field) of Organization's Research experience. Registered Nursing License; ACRP

Experienced Virtual Site Operations Director who will be responsible for the operational oversight and daily management of the Clinical Research Coordinator team and Site Operations Managers. The Virtual Site Operations Director will problem-solve complex situations, develop and implement group training, and process and document best practices.
**What you will do:**

+ Supervise Site Operations Managers/Clinical Research Coordinators and regularly communicate performance expectations and guidelines

+ Work with and advise the Site Operations Managers and Clinical Project Managers to identify the appropriate Clinical Research Coordinator for trial studies based on the individual's experience, knowledge, etc.

+ Assess clinical trial projects to appropriately scope resourcing needs on a per-project basis

+ Gauge virtual site risks and aid in providing mitigation strategies for complex problems

+ Develop, oversee, and optimize the Clinical Research Coordinator hiring and onboarding processes

+ Participate in project meetings, as needed Identify and recommend improvement initiatives

+ Participate in required training and education programs.

+ Responsible for education of other personnel and vendors regarding clinical research, as necessary

+ Conducts performance reviews, calibration sessions, and feedback discussions.

+ Performs competency assessments across his/her team, and implements and monitors development plans with direct reports

**About you:**

+ Bachelor s degree in biology, clinical research, project management, clinical research nursing or related field 7+ years of pharmaceutical-sponsored clinical research experience

+ 3-5+ years of experience managing Clinical Research Coordinators Experience with staff/task oversight, ideally in a matrixes environment

+ Tech-savvy with the skills and ability to apply new systems to everyday tasks

+ Experience with call center solutions is a plus

+ Understand the importance of adaptability and eagerness to learn and adapt to technology changes over time

+ Extraordinary organizational skills and ability to manage tasks with competing priorities

+ Strategic thinking and problem-solving aptitude

+ Exceptional team management skills

+ Excellent verbal and written communication

+ Strong interpersonal, leadership, and analytical skills

**About the Organization:**

This organization is reinventing decentralized clinical trials to help the vast majority of potential patients that currently cannot access clinical research. The vision is that any patient, no matter where they are located, should be able to participate in clinical trials at home and with their doctors. This is made possible through a unique suite of tools designed to engage patients in clinical trials across all settings, be it at home, at their local clinic, or other places in their community. This starts with a leading decentralized clinical trial software platform which is an all-in-one, purpose-built eClinical software system, with every tool needed to manage and collect data for decentralized clinical trials. This includes ePRO, eCOA, eConsent, Telemedicine, and much more. This organization also offers a virtual research site, complete with virtual investigators, research coordinators, mobile nursing, and other healthcare staff that administer care to patients where convenient for them, just like any other research site, but with the ability to stand up anywhere and with greater patient convenience and reach. Notably, this organization is the pioneer of the BYOP or Bring Your Physician model, allowing patients to use their doctors to participate in clinical trials.

P1

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** ** ** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

**About Kelly** ** **

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center.
Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Wake Research is a recognized leader in clinical research and one of the largest Phase I-IV clinical trial service companies in North America. Wake Research is owned by M3, Inc., a global healthcare services company. M3-Wake Research is an organization of integrated investigational sites, committed to excellence, working closely with and meeting the needs of biopharmaceutical, biotechnology, medical device, and pharmaceutical industries. M3-Wake Research's 23 sites, with over 35 years of clinical research experience, have conducted over 7,000 research studies for hundreds of pharmaceutical and biotech sponsors and CROs. Due to continued growth and expansion, we are seeking a Site Director in Dunn, NC.

Manages site activities to ensure delivery of site targets as received from senior management. Provides direct or indirect supervision of all clinical and administrative aspects of a clinical trial within the research site to ensure delivery of targets and quality.
Essential Duties and Responsibilities:

Including, but not limited to the following:

Responsible for site assessments, pre-trial assessments, site initiation, subject recruitment and retention, monitoring and close-out

Conducts pre-study site selection visits and assessments

Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct

Schedules staff to cover subjects' visit needs

Conducts staff reviews

Works to ensure enrollment goals of the study center are being met

Monitors subject visits

Supports the team and investigators in overall conduct of the trials

Follows the established monitoring SOPs both corporate and clinical, as well as protocol for specific monitoring plan

Works with QA/QC program prior to sponsor visit

Oversees employees' work before monitoring

Reviews budgets, including clinical research and physicians' costs

Works with the corporate office to evaluate recruitment plans and study start up

Oversees protocol, regulations, and compliance training; ensures training is up to date

Oversee the site financial performance

Train and develop site staff. Ensure that site team understands and performs according to established KPI

Supervisory Responsibility: Yes

Requirements

Education and Training Required: Bachelor's degree or equivalent and relevant formal academic experience. Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA) or equivalent certification, preferred.

Minimum Experience: 5+ years of relevant experience as a clinical research associate or clinical research coordinator is required. Must have experience managing trials.

Knowledge, Skill, Ability: Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs. Solid teamwork, organizational, interpersonal, attention to detail, and problem-solving skills.

Strong written and verbal communication skills. An ability to consume, absorb, and analyze large amounts of information. Ability to multi-task, work under time constraints, work independently and cooperatively with interdisciplinary teams. Strong computer skills in appropriate software and related company clinical systems are required

Benefits

Competitive salary

Advancement and career opportunities

401(k), 401(k) matching

Dental insurance

Disability insurance

Employee assistance program

Flexible spending account

Health insurance

Life insurance

Paid time off

Vision insurance