Medical Director

About Us

CenExel is a leading nationwide clinical research site and patient network
serving the life sciences industry. Leading in CNS and early phase studies, our
18 science-led Centers of Excellence deliver the right patients, at the right
time, in the right place. Recently acquired by BayPine Capital Partners, our
research sites provide unparalleled medical and scientific support in the design
and execution of clinical trials. Our world-class PIs, advanced patient
engagement strategies, premium data analytics, and integrated operations
optimize every step of the clinical trial process.

Along with an exceptional work environment that promotes teamwork, positive
leadership, and optimal work-life balance, CenExel Clinical Research also
provides highly competitive compensation and a generous benefits package to full
time employees after 30 days of employment including Health Insurance, Dental,
Vision, LTD, STD, Life Ins, and 401k.

Job Summary

The Medical Director assumes site responsibility other than those
responsibilities specifically intended for the PI. This role ensures adherence
to protocol requirements, protects the rights and welfare of participants,
assures the integrity of data generated at the site and directs the conduct of
the clinical investigation according to federal and state regulations and
guidance documents.

Essential Responsibilities and Duties

* Provides medical direction and overall supervision of the medical aspects of
the clinical trial site.
* Ensures that safety of study volunteers is not compromised.
* Develops, approves, and implements policies and best practices including
continuous quality improvement programs.
* Assists in determining the feasibility of site to execute protocols
effectively and efficiently.
* Assists in protocol development when request by sponsor or CRO.
* Monitors and evaluates implementation and effectiveness of quality programs
and assessments.
* Ensures that adequate resources are provided for performance of work and
assessment activities.
* Attends management reviews, monthly staff meetings, study initiation
meetings, monitoring visits, regulatory and sponsor audits as needed.
* Oversees and trains Investigators as needed.
* Provides updates and status reports to owners on a regular basis, report on
performance against plan.
* Acts as a liaison for site to external medical providers, the medical
community, sponsor, CRO and inspection agencies.
* Reviews clinical trial protocols and make recommendations as necessary.
* Interviews and hires new staff as needed.
* Takes part in communications, support, and provide insight for projects
including staffing, timelines and key data issues.
* Hires, trains, supervises, and evaluates personnel. Champions and enforces
the strictest adherence to best practices, FDA Code of Federal Regulations,
ICH (International Conference on Harmonization), GCP (Good Clinical
Practices), CenExel standard operating procedures, site Working Practices,
protocol, and company guidelines and policies. Retrains and implements
corrective and preventative actions, as needed.
* Assumes other duties and responsibilities as assigned. The above
responsibilities are a general description of the level and nature of the
work assigned to this classification and are not to be considered as all
inclusive.

Education/Experience/Skills

* Must be able to effectively communicate verbally and in writing.
* Licensed MD or Relevant Experience that will translate with Doctorate Degree.
* At least two years of Clinical Trial Management and Oversite required.
* Must be self-directed and able to work with minimal supervision.
* Must have in depth knowledge of FDA regulations.
* Able to take a flexible approach to shifting priorities.
* Able to manage multiple projects and responsibilities.
* Motivated to work consistently in a fast paced and rapidly changing
environment.

Working Conditions

1. Indoor, Office environment.
2. Essential physical requirements include sitting, typing, standing, walking.
3. Lightly active position, occasional lifting of up to 20 pounds.
4. Reporting to work, as scheduled, is essential.
5. On site work arrangement.
6. Occassional travel.

CenExel Clinical Research is an Equal Opportunity Employer. All applicants will
be considered for employment without regards to race, color, religion, sex,
sexual orientation, gender identity, national origin, veteran, or status.