Site Director

Charlotte, NC 

Our rapidly growing clinical research facility is looking to hire a qualified candidate for the full-time position of Lead Clinical Research Coordinator. The ideal candidate will possess certification such as an RN, LPN, MA, phlebotomy, or comparable, prior clinical research experience, and the ability to work in a high-volume setting and exhibit strong interpersonal skills. Pay is commensurate with skill and experience.

The ObjectiveHealth Way

Our approach is to directly impact lives. We are identifying and caring for patients where they’re already being seen – in the gastroenterology practice. By partnering with leading GI physicians, we have created premier clinical trial centers that are working together to provide the necessary data aimed at developing new therapies for NASH and improving patient outcomes.

Everything we do at ObjectiveHealth is focused on helping patients. We’re offering them more regular, specialized care. We’re addressing a need. We’re making innovative, new treatment options available. We’re changing lives through an innovative approach to research and patient care. But what sets us apart isn’t our methodology, our science, or even our decades of experience in the medical field. It’s our people. People who view medicine in a new way – one that’s aimed at developing groundbreaking treatment options for patients. People who share a passion for advancing our unique brand of patient care.

We invite you to be part of the innovation we’re working toward.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Identification, screening, randomization and enrollment of patients in IRB approved clinical trial protocols.
• Complete all trial related procedures, including clinic visits, etc., according to each individual IRB approved clinical trial protocol, established Standard Operating Procedures (SOPs), Sponsor specifications and Good Clinical Practice (GCP).
• Ability to perform direct patient care activities such as consenting patients, physical assessments, blood draws, medication administration, ECG, etc.
• Building and maintaining excellent communication with Principal Investigators and others needed to conduct quality research to foster an excellent reputation of site research.
• Ensure efficient monitoring of all trials by ensuring that the data is clean and entered accurately into the sponsor EDC in timely fashion.
• Supervise site initiation activities as well as oversee the set-up and maintenance of studies.
• Create and submit Regulatory and associating documents as needed to start new clinical trials.
• Maintain both new and ongoing IRB processes.
• Revise IRB submissions in response to identified problems and resolve issues in a timely manner.
• Create and maintain up to date Source Documents (paper and electronic) for each study.
• Review audit findings from medical monitor and/or internal auditor and discuss with Associate Site Director and/or other Executives when needed.
• Tracks and obtains knowledge to observe and report adverse/serious adverse events, protocol violations/deviations in a timely and accurate manner.
• Attend all clinical operations meetings and conduct strategic planning as needed.
• Attend Investigator meetings and training sessions as needed. This may require occasional out of town travel.
• Additional duties as assigned.
• Employee evaluations will be conducted by the Executive Site Director annually, or more frequently if deemed necessary.

KNOWLEDGE, SKILLS AND ABILITIES:

• Certification, specifically to complete blood draws.
• Ability to maintain professionalism and professional standards.
• Technologically advanced: Ability to learn new software systems easily.
• Must have a sense of urgency and set priorities.
• Must have the desire for regular and efficient patient interaction including in-person scheduled office visits, phone calls, and emails.
• Identify and resolve problems effectively and efficiently.
• Excellent communication and organizational skills for managing workflow and follow-up.
• Ability to demonstrate reliability and maintain confidentiality.
• Knowledge of electronic medical record systems and EDC systems required.
• Knowledge of CTMS systems preferred.
• Experience submitting IRB applications (new and amendments) preferred.

EDUCATION AND EXPERIENCE:

• High School Diploma or Equivalent required.
• Related medical certification (RN, Phlebotomy, etc.) required.
• 2 years experience in related industry-funded clinical research.
• Valid U.S. Driver’s License
  

BENEFITS:

ObjectiveHealth offers competitive compensation, 401(k), Short and Long Term Disability, Health Savings and Flexible Spending Accounts, health, dental and vision insurance, generous PTO, and several other benefits.

EEO EMPLOYER:

ObjectiveHealth provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

E-VERIFY PARTICIPANT:

Please Note: ObjectiveHealth participates in E-Verify and performs background checks on all new hires. We will provide the Social Security Administration (SSA) and if necessary, the Department of Homeland Security (DHS), with information from each new employee’s form I-9 to confirm work authorization.

COMPENSATION:

Pay is commensurate with skill and experience. Sign on bonus eligible.

Job Type: Full-time, Non-exempt

COVID-19 considerations:
Providing continued in-person care is necessary for the health and well-being of our patients. To further protect employees during this time, we have implemented COVID-19 specific policies and PPE procedures based on current CDC recommendations.