Edc Project Manager Jobs in Texas (NOW HIRING)

Summary: The Pharmacy Assistant is responsible for assisting with the day-to-day operations of clinical trials and office support activities for the pharmacy to facilitate the efficient operation of the Clinical team. They will attend meetings and events to promote studies, work closely with Laboratory and Clinical team to assist and cross train, as well as document and report on the daily operations of pharmacy activities and status. This person must be able to understand clinical research priorities and establish a workflow to complete all required activities in a timely manner. This position is responsible for a broad range of duties involving confidential information. The Pharmacy Assistant must be organized, excel at multi-tasking, detail-oriented, an excellent written and oral communicator, and be able to provide high quality patient care. This person will collaborate very closely with other members of the PCR team, external vendors, and therefore must be highly collaborative, goal-oriented, flexible, and communicative. An ideal candidate will be responsive, thoughtful, empathetic, self-motivated, and a team-player. This role reports directly to the Clinical Operations Manager.

Duties and Responsibilities:

Pharmacy Duties:

• Receive investigational product (IP) shipments on site.
• Account for all shipment contents and complete required documentation.
• Confirm in sponsor assigned vendor portal (example: IWRS/IXRS/EDC) shipment received or notify sponsor that shipment was received if there was no IWRS/IXRS system.
• Document shipment and its contents on the IP logs.
• Upload monthly temperature logs within the first week of the month for individual or multiple sites
• Assessing, documenting, and reporting temperature excursions as they occur to include completion of any excursion paperwork provided by the sponsor
• IP dispensing and return accountability from clinical team
• Double verification of IP dispensation and returns.
• Manage Pharmacy Binder on CRIO eREG
• Host unblinded routine monitoring visits
• Daily reconciliation of applicable pharmacy logs
• Maintain pharmacy organization and current IP supply
• Coordinate routine temperature monitor calibrations
• Complete manual temperature recording as applicable
• Perform IP administration
• Orders supplies as needed from local pharmacy or selected vendors if applicable
• Maintains pharmacy supply inventories
• Ensures appropriate temperature conditions for pharmacy and pharmacy equipment (i.e. refrigerators and freezers)
• Provides training to support staff members
• Coordinates the return of IP with Sponsor/CRO
• Calls in prescriptions on behalf of PCR for patients if applicable to site process
• Labels IP for internal tracking
• Provides subjects with IP instruction and education
• Collaborate and cross-train with Lab and Clinic personnel if applicable at site
• Always maintain subject and document confidentiality, understand, and comply with the appropriate sponsor requirements and regulations which include the Food and Drug Administration, good clinical practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures
• Willing to travel to provide additional support to other sites as needed

Administration:

• Create and maintain reports and/or spreadsheets as requested
• Assist with maintaining study documents and electronic regulatory documents
• Schedules and coordinates meetings with sponsors for purposes of review of pharmacy related items alongside Clinical Research Project Manager

Duties, responsibilities, and activities may change, or new ones may be assigned at any time.

Qualifications, Education & Experience:

• High School Diploma or general education degree (GED)
• Medical Assistant with 2 years of front and back-office experience or 2 years Pharmacy Technician experience
• Proficient in all Microsoft Office applications
• Demonstrated organizational skills and outstanding time management, including keen attention to detail with the ability to track multiple projects at one time
• Strong written and oral communication skills
• Knowledge of basic medical terminology
• Possess impeccable integrity and personal and professional values that are consistent with PCR’s high standards and mission
• Comply with the company policies, code of ethics, and guiding values always
• Proficient in English and Spanish preferred

Knowledge Skills and Other Abilities:

• Must be able to effectively communicate with all levels of internal and external contacts
• Ability to work independently and multi-task in a fast-paced team environment
• Strong people skills including ability to interact with individuals from diverse backgrounds and to oversee confidential matters and sensitive information with discretion and judgment
• Must possess a positive, friendly, and professional demeanor, particularly when interacting with patients
• Must be able to work independently and collaborate with a team
• Ability to interpret and adhere to clinical research protocols
• Strong problem-solving and decision-making skills, particularly when under pressure
• Proactive at identifying, addressing, and solving issues in real time
• Energetic self-starter, results oriented, and the ability to work effectively in an entrepreneurial environment

Work Environment and Physical Demands:

The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Work is performed in an office/laboratory and/or a clinical environment.
• Occasional travel may be required domestic and/or international.
• Ability to work in an upright and/or stationary position for 6-10 hours per day.
• Frequent mobility required.
• Occasional squatting, kneeling, or bending.
• Light to moderate lifting and carrying (or otherwise moves) objects with a maximum lift of 20-50 lbs.

Perks of working at Summit Pinnacle Clinical Research:

• 401k
• Medical, dental, vision, long term disability, short term disability, FSA, and life insurance
• 3 weeks of paid time off
• 14 paid company holidays
• Scrub voucher (specific positions apply)
• And more!

Summit Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.