Career Opportunities

Description

Top clinical manager who effectively identifies, develops and leads a team of interdependent clinical support staff and department leaders

Direct Reports:

• Clinical Medical Assistant Staff to PENTA’s Physicians and Advanced Practice Providers
• Clinical Department leaders: Allergy Supervisor, Lead Clinical Research Coordinator, Lead Scribe
• Estimated 75% of time involved with CMA staff and 25% with direct-report supervisor(s) and lead(s)

Essential Functions:

1. Ability to lead and develop clinical support staff by building a cohesive and skilled clinical staff who reflect PENTA’s Core Values of Caring, Respect, Teamwork, and Quality
2. A results-oriented leader who has the ability to cultivate a culture of interdependent teamwork and personal accountability
3. Critical thinker who has a “big picture” approach to optimize the talents and abilities of the clinical support staff Sees the “big picture” and assigns support
4. The ability to lead and manage the entire team without bias or favoritism
5. Supports clear communication of clinical information by acting as a clinical liaison with those involved in the patient care continuum
6. Manages a clinical purchasing system that contains cost, sets par levels, orders in a timely manner, and uses supplies within expiration dates
7. Maintains a safe work environment by ensuring compliance with OSHA standards and public health protocols for infection control and disease transmission prevention

Core Competencies:

• Leadership: Clear in setting expectations, effective in delegation, fair and firm in oversight
• Team Builder: Develops staff who takes the initiative to serve their provider and others
• Critical Thinker: Anticipates needs and draws fluidly from all assigned departments
• Effective Communicator: Spoken and written word should be clear and concise
• Organizer: Ability to deploy human capital and supply resources for optimal benefit

Requirements

• Bachelor’s Degree from accredited university
• Minimum eight years of clinical experience
• Minimum five years of experience managing a team of five to ten staff
• Highly desired – Degree in Healthcare/Science or BSN

Job Summary:

Responsible for the overall leadership and direction of all clinical research operations including, but not limited to, fiscal management, study and site operations, regulatory processes, and patient recruitment.  The Lead Clinical Research Coordinator is responsible for developing growth strategies and managing and/or coordinating clinical studies.

Essential Functions:

• Promote business growth with PENTA investigators and increase visibility within the pharmaceutical industry. Ensure the safety of study subjects across all trials.
• Assess clinical trials in terms of study impact on-site resources, labor cost, cost by procedure, and practice suitability. Complete feasibilities, facilitate sponsor pre-site visits, and secure clinical trials for the PENTA research department.
• Coordinate Phase I through Phase IV clinical pharmaceutical trials. Duties include obtaining suitable patients who meet all admission criteria, assisting with patient education, adhering to the study protocol, and maintaining proper documentation according to the protocol and regulatory requirements.  Documenting laboratory data and adverse reactions, correcting discrepancies, anticipating possible problems and resolutions, maintaining communication with the monitor from the sponsoring company, and performing technical requirements of the protocol which included phlebotomy.
• Develop and implement the marketing plan for PENTA research as well as the recruitment plan for each enrolling study. Monitor subject accrual rates and implement action plans for accrual issues. 
• Complete all IRB documents to obtain regulatory approval. Manage annual reports to the IRB.  Document protocol deviations and report back to the IRB as required.
• Develop the budget for each study and perform negotiations with study sponsors, invoice sponsors as required and prepare the allocation spreadsheet for each check. Manage research expenses.  Review and approve study contracts.
• Develop and revise the PENTA research Standard Operating Procedures (SOP’s). Ensure research staff adherence to SOP’s and federal requirements.
• Train and supervise support staff ensuring adherence to protocol and regulatory requirements.
• Manage special projects and other research initiatives as assigned.

Requirements

• Relevant degree (e.g. Bachelor’s degree in a relevant discipline such as Health Administration, Nursing or Business) or equivalent combination of experience and education (certification CCRC).
• Minimum 5 years of experience in pharmaceutical research including supervisory experience

Key Competencies:

Knowledge of ICH, GCP, CFR guidelines, and industry requirements
IATA certification – knowledge in specimen processing and shipment
Clinical knowledge (Phlebotomy, ECG’s)
Excellent communication skills both oral and written
Excellent interpersonal skills
Management experience
Problem-solving skills
Attention to detail