Clinical Research Coordinator (52749)

Responsibilities

Perform all research coordinator duties required to adhere to FDA guidelines and study protocols, and facilitate the daily clinical trial activities required to conduct the study including, but not limited to:

Subject recruitment, screening and enrollment

Collection of laboratory specimens, informed consent and other data from subject

Maintenance of source documents including CRF (case report form) completion and review for accuracy

Participation in site monitoring visits and audits

Documentation of laboratory and histological procedures. Ensure accurate labeling of slide photos

Filing and maintenance of all study related documents

Documents adverse events and notifies principal investigator and appropriate agencies. Notifies Director, sponsor and IRB of any serious adverse events

Assist physician with all procedures to include excisions, injections, laser treatments, wound care, post-op care and dressing changes. Set up exam room for specific procedure as indicated

Provide patient education and literature. Take pre- and post-treatment pictures

Clean pack and sterilize instruments. Assists in cleaning rooms

Monitor physician’s schedule to maintain timely flow

Ensure studies are conducted according to protocol and in accordance with GCP, ICH and FDA guidelines. Ensure IRB guideline and SOP compliance

Ensure all study timelines are met and study folders are kept updated and accurate

Work closely with the physician(s) and medical provider(s) assigned to the study

Oversee, participate and enter in timely manner data entry, perform study monitoring in peer-to-peer inter- rated methodology

Enter all data within 2 days of study visit by Research Coordinators and query resolution performed within 2 days of query. Random QC monitoring process to be established by Director and conducted by Research Coordinators in peer-to-peer inter-rated methodology

Perform other tasks/duties as requested or assigned by PI/sub-I and Director

Must be able to travel to oversee studies in multiple sites as required

Coordinate study schedules with practice personnel

Train other team members on study protocols and visits

Preferred

Health Sciences background preferred

Certified Clinical Research Coordinator (CCRC) designation a plus

Benefits

Medical, Dental, and Vision insurance

Short-term/Long-term disability

Life and other voluntary plans

401(k) plan

Employee Referral Program

Paid Time-Off

Company-Paid Holidays

Platinum Dermatology builds partnerships with reputable dermatology practices to empower growth and best-in-class dermatology services. It is a sub-organization of West Dermatology.

Dallas, Texas, USA

http://www.platinumderm.com

Late Stage

Total Funding

unknown

2022-06-22

Acquired

Leadership Team

Michael Pennington

Chief Executive Officer

Jerald Sklar M.D.

Founding Partner

Recent News

Business Wire

Platinum Dermatology Partners Launches Platinum Aesthetics Research Committee to Shape The Future of Aesthetic Dermatology

2024-12-05

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Qualifications

Bachelor's Degree required

3 years prior experience; knowledge of phlebotomy techniques

Knowledge of IRB regulatory submission process, GCPs, and CFR related to research

Committed to executing exceptional patient service and satisfaction

Ability to support the organization's preferences and priorities

Ability to generate respect and trust from colleagues and leadership

Excellent listening, oral and written communication skills

Tactful, mature and able to interact well with diverse personalities

Able to exemplify professional behavior in all aspects of position

Computer literate with good keyboarding skills

Ability to operate basic office equipment such as a phone, fax, copier, printer etc

Must have a valid driver's license

Health Sciences background preferred

Certified Clinical Research Coordinator (CCRC) designation a plus

Required skills

Clinical Trial Research, Phlebotomy, IRB Regulatory Submissions, Clinical Practice (GCP), FDA Research Guidelines, ICH Guidelines, Code of Federal Regulations (CFR)

Preferred skills

Health Sciences background preferred

Experience

3+ years