DEFINITION An individual who, under the direction and ongoing supervision of the Principal Investigator, aids in the daily function of clinical research studies being performed by Alliance Clinical Network.

ESSENTIAL DUTIES AND RESPONSIBILITIES: Responsibilities may include, but are not limited to the following:

Manage entire office & staff to ensure operation success

Communicates effectively and courteously with study patients, staff, and vendors

Manage study start-up documentation, training, supplies, and timelines on study protocols

Work closely with CRO/CRA/IRB

Comprehensive knowledge of FDA, GCP and HIPAA as applied to clinical research

Knowledge of current studies being conducted

Comprehensive knowledge of company's SOPs, policies and Confidentiality agreements

Hire and Train new staff

Management of staff

Conduct continuous staff training and meeting

Quality control of studies and study documents

Maintains office site regulatory files

Document temperatures for IP stored on-site

Participate in offsite recruitment events as directed by Alliance Clinical Network

Audit study e-source documents to comply with study protocol

Other tasks and responsibilities as required by Alliance Clinical Network to facilitate business needs

Compensation is an annual base salary of $80,000 plus bonus. Maximum eligible bonus annually is $80,000.

Work Experience:

Minimum requirements include knowledge and skills developed through 5-10 years of work experience in Clinical research.

5 years of Clinical Research Coordinator

5 years Management experience

Education:

Associate's degree preferred or the equivalent experience in related field

Technical Skills or Knowledge:

Proficient in Microsoft Word, Excel and Adobe Acrobat.

Clinical Research & Market knowledge.

Certified Medical Assistant and/or phlebotomy

CPR and first aid certification

IATA and/or Safe-T-Pak certification for shipment lab specimens and/or dry ice

GCP and protection of Human Subject Participants

Preferred Competencies

Management skills

Communication and negotiation skills

Ability to build rapport

Time management and planning skills

Good presentation skills

Analytical skills.

Excellent multi-tasking

Spanish speaker preferred

Ability to operate with limited direction

Good customer service skills

Conflict resolution

Problem solver

Benefits:

Dental insurance

Health insurance

Paid time off

Vision insurance

Schedule:

Day shift

Monday to Friday

Weekend availability

Supplemental pay types:

Bonus pay

Ability to commute/relocate:

Dallas, TX 75230: Reliably commute or planning to relocate before starting work (Required)