Trial Disclosure Associate

Title: Trial Disclosure Associate
Length of assignment: 1 year
Location: Remote
Minimum Pay Rate:$38 an hour

Responsibilities:
The Trial Disclosure Associate will be responsible for a variety of activities including but not limited to, study Registration/Results Postings, Agency Disclosure activities, companywide Redaction/Anonymization of clinical documents for public disclose,, and Access To Data processes.
Works closely with supports the Senior Associate, Trial Disclosure, CT,D, and Manager(s) of TD: to determine the drug trials required to be registered and results disclosed, to effectively communicate this information and related timelines to the applicable individuals involved in these activities, to provide guidance to and build cross-functional collaborative relationships, to coordinate the completion of these activities to achieve/ensure timely disclosure of accurate Works closely with/support the Senior Associate, Trial Disclosure, CTD and Manager(s) of TD: to provide writing support for global study registrations/results postings and amendment, support global registration updates and administrative needs, and monitoring milestone compliance and to provide support forcompany-widee Redaction/Anonymization of clinical documents for public disclosure and Access To Data processes.
Works supports/support the Senior Associate, Trial Disclosure, and Manager(s) of TD in operationalizing changes in both the US and International regulatory environment via participation in the development and implementation of SOPs/processes as create creates efficiency improvements/furthers system automation and related communication and training activities.
Identifies issues and escalates appropriately Participates in TD compliance prevention by providing QC checks and metrics as requested. Cross-trains with other Trial Disclosure staff.
Accountable for meeting the main objectives of assigned projects/roles and responsibilities within established timelines and with an appropriate quality level.
Daily interaction with Trial Disclosure Associate II and/or Manager(s) of TD as well as significant interface/communication with cross-functional areas.

Job Qualifications:
A bachelor degree (BA/BS) from an accredited college or university is required, preferably in a health or biological science field.
Must have 2+ years of experience in clinical trial registries, regulatory agency transparency,y or experience in a related area such as quality or regulatory and working knowledge of drug development.
Must be familiar with ICH and GCP guidelines have good organizational and communication skills and d competent in the n application of standard business procedures (SOPs/Work Instructions, OEC).
Must have the ability to prioritize tasks and responsibilities daily and work well under deadline pressure in a team environment to execute goals to ensure they are achieved (i.emaximizees individual skills utilizing the collective skills of the CTD area).
Comfortable working in and Excel, Word and open to learning new systems

What are the top 3-5 skills, exp,erience or education required for this position:
1 Authoring of clinical or technical documents, or strong experience in writing.
2 Excellent communication (written & verbal), clear and concise communications.
3 Demonstrated ability to project manage and prioritize workload to meet deadlines. Ability to shift daily priorities
4 Exceptional attention to detail
5 Comfortable working in Excel,and Word and comfortable with learning new systems.
What is nice to have (but not required) regarding skills, experience, education, or certification: - Previous working knowledge of clinicaltrials.gov
- Previous work experience as a medical writer. Experience with writing study protocols or other technical documents

About Us
Below is a brief introduction of SPECTRAFORCE, the benefits we offer, and the disclaimers:
Established in 2004, SPECTRAFORCE is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes and strong and passionate client-engaged teams.

We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 130 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities, and Transportation.

SPECTRAFORCE is built on a concept of "human connection," defined by our branding attitude of NEWJOBPHORIA, which is the excitement of bringing joy and freedom to the work lifestyle so our people (and clients) can reach their highest potential. Our entire workflow and teams are trained to cultivate the joy of NEWJOBPHORIA with candidates and employees throughout their engagement with SPECTRAFORCE.

Benefits: SPECTRAFORCE offers ACA-compliant health benefits as well as dental, vision, accident, and hospital indemnity insurance. Additional benefits SPECTRAFORCE offers to eligible employees include commuter benefits, a 401K plan with matching, and a referral bonus program. SPECTRAFORCE offers unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability, or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at if you require reasonable accommodation