JOB TITLE: Clinical Research Coordinator (CRC II)

GENERAL SUMMARY OF DUTIES – Responsible for coordinating all aspects of clinical trials with limited oversight with the strictest adherence to ICH, GCP, protocol, and ACMR guidelines, regulations, and policies; Responsible for the delegation of tasks to Research Assistants ensuring the accurate completion and maintenance of study components and duties.

MANAGER – Clinical Trial Manager

RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

Supervisory

• 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
• Assessing the daily performance and productivity of designated Research Assistants
• Delegating tasks to RA’s; ensuring goals of accuracy and timeliness are met
• On-going education and training of RA’s regarding protocol specific tools, updates, roles, responsibilities and expectations
• Work closely with management in maintaining a positive and productive work environment
• Assist with selection and hiring of study staff
• Assist with disciplinary process as needed including employee meetings and write-ups
• Assist the CTM in planning, creating processes and training's
• Other duties as assigned

Study Coordination

• Maintaining overall protocol timeliness and study enrollment goals
• Coordinating all aspects of patient involvement from study initiation until study completion;
• Study start-up:


• Assist in the creation of thorough and accurate source documents;
• Work collaboratively with other internal departments, sponsors and investigators to ensure protocols are understood and assist in the training's of staff members
• Participate in IMs and SIVs; communicating with sponsors and representatives
• Ensure site receives accurate information and supplies from sponsors (ie: source, protocol, scales, supplies, approvals, contacts, etc.)
• Assists CTM with study start-up tasks as needed
• Screening participants for actively enrolling studies
• Assist in reviewing all subject history from Pre-Enrollment and Enrollment confirming information with potential subject and study physician
• Educating potential participants and caregivers on protocol specific details and expectations;
• Working with the physician to address all questions and concerns relates to the trial and informed consent process;
• Maintaining thorough knowledge of study specific inclusion/exclusion criteria
• Coordinating scheduled visits and adhering to protocol visit windows and timelines
  • vital signs, EKGs, blood draws and other assessments as assigned


• Performing safety and efficacy assessments per protocol
• Collaborating with the research pharmacist to perform drug accountability and compliance at each visit and educating subject on proper dosing regimen
• Accurate and timely completion of source documents recording participant’s participation in study
• Communicate closely with all departments to ensure study visits are coordinated in compliance with protocol and GCP guidelines
• Assist investigators in collection of information from participants regarding AEs, concomitant medications and other changes throughout participation
• Responsible for subject scheduling
• Responsible for timely data entry and query resolution
• Timely reporting of study events (SAEs, protocol deviations, etc) to appropriate departments and other outside agencies (Sponsors, CRO’s, etc.)
• Following subjects through study completion and creating follow-up care plan with physician, study subject and primary care provider;
• Ensuring preparation for and facilitating of all study monitoring visits and following up promptly with monitor follow-up letters
• Prompt and professional communication with sponsors, representatives and other study related parties
• Maintaining professional and appropriate interactions with study subjects, caregivers, sponsors and all other study related personnel, and staff members
• Interacting with nursing/unit staff on a daily basis as applicable to ensure communication and accurate completion of source through daily chart review
• Keeping CTM informed of study status and any study-related issues
• Assist CTM with oversight of Vendors, Accounting, Regulatory, Client Satisfaction, Recruitment, Quality and Trial Outcomes
• Other duties as assigned

• Demonstrated expertise in:


• knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials
• providing strong leadership and mentor ship to others
• developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level
• crisis management and problem solving; ability to react calmly and effectively in emergent situations
• working independently with limited supervision as well as functioning as part of a team
• communicating clearly both written and verbally
• Highly proficient in:
• In the use of technology required for the completion of study visits and study conduct
• completing paperwork with precision, accuracy, and attention to detail
• meeting timelines and attention to detail
• prioritizing daily tasks with minimal guidance
• using medical equipment and instruments to administer study subject care
• Established skill in
• Basic clinical skills to obtain patient safety measures (measure pulse, respiration rate, blood pressure, EKG, height and weight, draw and process blood samples)
• Medical terminology
• Handling high enrolling inpatient studies with limited supervision
• Consistently handling a heavy workload with limited supervision

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.

• Service Excellence: We believe all relationships with co-workers, sponsors, and subjects are partnerships. We demonstrate service excellence through a personal commitment to producing high quality, high value work, and delivering on time and on target results for every partner.
• Safety: We believe that physical and psychological safety are foundational for a healthy organization. We proactively identify and mitigate safety risks as part of our daily work and value those who speak up for safety.
• Resilience: We believe resilience is critical for doing our best work. We demonstrate resilience by remaining flexible, adapting to sudden change, and bouncing back from difficult situations with grace and confidence.
• Team Orientation: We believe that having a team orientation leads to individual and organizational success. We demonstrate team orientation by working collaboratively and leveraging collective knowledge, ideas, and strengths to achieve a common goal.
• Ethical Behavior: We believe the pillars of ethical behavior are integrity, honesty, respect, courtesy, and caring. We demonstrate ethical behavior by modeling professional standards of conduct.
• Mutual Respect: We believe that mutual respect cultivates a supportive workplace. We demonstrate mutual respect by embracing diverse perspectives, sharing ideas, and trusting in each other’s abilities.
• Open Communication: We believe that open communication results in a rich and rewarding dialogue that allows for the flow of energy and creativity. We demonstrate open communication by listening for understanding, speaking up without fear, freely sharing experiences, and soliciting ideas and opinions from others.

CERTIFICATE/LICENSE – CCRC required CPR training provided; other training provided on an as needed basis

EDUCATION REQUIREMENTS- Bachelors Required

PHYSICAL DEMANDS/WORKING CONDITIONS – Standard operating hours are Monday through Friday, 8:00. to 4:30p.m. CRC’s are often required to see patients or 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 and medical/psychiatric diagnoses disorders; therefore, candidates must possess the ability to resolve conflicts immediately and diffuse potentially escalating events before they occur.