Clinical Research Associate - Western Region

Healthpoint, Ltd. is uniquely committed to the prevention and treatment of diseased and traumatized skin and related soft tissue.  Healthpoint, Ltd. is an operating company of DFB Pharmaceuticals, Inc., a privately owned specialty pharmaceutical company located in Fort Worth, Texas.  Established in 1990 following the purchase of Dermatology Products of Texas (DPT), a San Antonio based pharmaceutical manufacturing firm which began operations in the 1930’s, DFB has grown to over 1,700 employees encompassing three operating divisions.  Through acquisitions paired with organic growth, DFB has become a fully integrated pharmaceutical business with plans for further near-term growth.  The company is segregated into distinct branded pharmaceutical business units (Healthpoint Ltd., tissue management focus; Coria Laboratories Ltd., dermatology focus), and a contract services unit (DPT Laboratories).

 

Research and Development is located adjacent to the company headquarters in Fort Worth, Texas, close to the University of North Texas Health Sciences Center.  Basic and applied research, project management, regulatory affairs, quality, medical and clinical affairs occupy adjacent space and work closely together in a newly constructed 80,000 ft2 facility. 

Sales and marketing activities are enhanced by formal corporate development and training, a responsive Customer Care organization, a dedicated Healthcare Systems group ensuring product availability in all distribution centers, and a professional Clinical Education team that coordinates continuing medical education to practitioners.

By attracting and retaining dynamic and innovative employees, Healthpoint is well positioned to grow its core businesses, pursue strategic business partnerships, and expand its portfolio of products and technologies through dedicated research and NDA development efforts.

 

Healthpoint is currently seeking candidates to fill the following role in our western region: Clinical Research Associate.

 

Candidates may live anywhere within the region, preferably near a major metro or airport.

 

JOB SUMMARY:

 

Within Clinical Affairs, under the guidance of a Senior Clinical Research Associate or Study Management Specialist, the position accurately performs clinical site monitoring functions to internal standard operating procedures and work practice guidelines and external GCP/ICH and FDA standards on Phase I through IV clinical trials from investigator selection and study initiation through study close-out. Demonstrates strong organizational and interpersonal skills and competency with various computer applications including word processing. Estimated travel time is up to 80%. Reports to the Study Management Specialist (Study Manager).

 

DUTIES AND RESPONSIBILIITIES 

 

·  Under the direction of a Study Manager or Lead CRA, provide clinical support on assigned studies. 

·  Assist with identification of investigators and clinical sites; conduct telephone screening and pre-study (evaluation/qualifying) visits.

·  Ensure collection, accuracy and filing of required regulatory documents.

·  Participate with site budget management.

·  Conduct study initiation visits.

·  Monitor clinical sites per the specific monitoring plan including enrollment expectations, review of CRFs, source data verification, and GCP compliance.

·  Conduct study closeout visits.

·  Complete and file all required reports and CRFs accurately and in a timely fashion.

·  Assist with program or study activities as assigned including general correspondence, database updates, central technical services, central IRB and Investigator Meeting planning. 

·  Become proficient with concepts of drug development, clinical study design, and study management. Becomes knowledgeable in assigned therapeutic area including an understanding of the disease, benefits and risks of therapy, and safety and efficacy evaluations.

·  Become knowledgeable in all Company written Standard Operating Procedures (SOPs) and Work Practice Guidelines as well as all applicable and established Good Clinical Practice (GCP)/ICH guidelines and regulations. 

·  Represents the company to external audiences.

·  Responsible for oversight of clinical site budgets and payments. May have limited responsibility for evaluation of vendor services, including contract monitors.

·  Regularly works with restricted information. Maintains subject confidentiality and prevents inappropriate disclosure of confidential information to persons inside and outside of the organization.

·  Participates in development of an outline of duties and project assignments. A degree of independence is exercised in completing assignments according to established guidelines and procedures.

 

CANDIDATE QUALIFICATIONS, SKILLS, EXPERIENCE & ATTRIBUTES:

 

·  Bachelor’s Degree (or equivalent) from an accredited College or University in nursing, pharmacy, biological sciences, chemistry, health related science or other appropriate scientific/technical discipline (Required).

·  Knowledge of GCP guidelines and regulations

·  2 years of experience in clinical research (Preferred)

·  Ability to use multiple technical and customer-focused skills/tasks. 

·  Experience in handling multiple tasks concurrently.

·  Possess excellent interpersonal skills.

·  Demonstrate complex and interrelated problem solving skills. 

·  Must be open to travel up to 80%

 

 

Keywords:  Nationwide, Massachusetts, New York, New England, Pennsylvania, Connecticut, Delaware, New Hampshire, Vermont, California, Oregon, Washington, Virginia, Florida, Idaho, Nevada, Utah, Arizona, Rhode Island, New Jersey, MA, NY, PA, CT, DE, NH, VT, CA, OR, WA, VA, FL, ID, NV, UT, AZ, RI, NJ, West, Western, Regional